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Last week we saw some FDA approvals come through, as well as research that explored the psychosocial outcomes of individuals who survived pediatric rhabdosarcoma. And finally, we’ll discuss another cancer vaccine clinical trial that got the green light from the Food and Drug Administration.
FDA Approved Besponsa for Children With Acute Lymphoblastic Leukemia
The first FDA approval of last week was one in the pediatric cancer space. The agency approved Besponsa for children who are at least 1 year old and have relapsed or refractory CD22-positive precursor acute lymphoblastic leukemia., also known as ALL.
The approval is coming after findings from a single-arm study involving 53 children. Of which, 22 — that’s 42% — achieved a complete response from the therapy, with the median duration of complete response being 8.2 months. Additionally, the majority of patients who achieved a complete response also had minimal residual disease negativity, which indicates that there were 5% or less blasts found in the bone marrow and no cancer cells detected in the blood.
Having a new treatment option for children with ALL is particularly exciting, as ALL is one of the most common pediatric cancers, according to the American Cancer Society.
FDA Approves Opdivo Plus Chemo for Unresectable or Metastatic Bladder Cancer
Last week, the FDA also approved an immunotherapy/chemotherapy regimen for certain patients with bladder cancer. Specifically, the agency OKed Opdivo plus cisplatin and gemcitabine for the frontline treatment of adults with unresectable or metastatic urothelial carcinoma.
This approval was backed by findings from the CheckMate-901 trial, which showed that the Opdivo-chemotherapy regimen improved overall survival (which is the time patients live before death of any cause) and progression-free survival (which is the time patients live without their disease worsening) compared to those who did not receive Opdivo. The median overall survival was 21.7 months for those who received Opdivo compared to 18.9 months for those who did not, while progression-free survival was 7.9 and 7.6 months, respectively.
FDA Approves Brukinsa, Gazyva Combo for Relapsed, Refractory Follicular Lymphoma
Last week, the Food and Drug Administration also approved Brukinsa plus Gazyva for patients with relapsed or refractory follicular lymphoma after findings from the ROSEWOOD trial showed that not only did more patients respond to the two-drug treatment compared to Gazyva alone, but also at a median follow-up of 19 months, more patients were still responding compared to the Gazvya arm as well.
Rhabdomyosarcoma Survivors May Have Poor Psychological Outcomes
A study published in the journal, Cancer, found that survivors of rhabdomyosarcoma — which is a rare cancer affecting soft tissues — may face increased risk of psychological challenges, especially if they were exposed to previous radiation therapy or have a history of smoking.
Researchers examined neurocognitive impairment, emotional distress and health-related quality of life in survivors compared to their siblings. Results showed higher rates of issues like memory impairment and emotional distress among survivors, with smoking linked to poorer outcomes. The CURE® team spoke with study author, Ellen van der Plas on the findings. Here is what she had to say.
Ovarian Cancer Vaccine Trial Gets FDA Clearance to Proceed
The FDA has given the green light for a clinical trial of a vaccine designed to treat advanced ovarian cancer. Known as Innocell, this personalized therapy utilizes cells from the patient's own tumor which is inactivated via riboflavin and UV light. The drug is being manufactured at City of Hope in Los Angeles, and the trial aims to assess the vaccine's safety and effectiveness in stimulating immune response.
This is one of the many cancer vaccines being explored and developed in the oncology space. Check back on prior CURE® coverage for updates on vaccines to treat breast, lung, skin and other cancers.
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In addition to a breakthrough therapy designation for a lung cancer drug, this week we’ll be talking a lot about additional side effects and health conditions that may come with a cancer diagnosis, and how to manage them.
We heard from an expert about using cannabis during cancer care, took a look at a patient population that may be more prone to cardiometabolic conditions after cancer treatment and we’ll highlight a study that’s looking at preventing infection and GVHD in patients with blood cancer who underwent a stem cell transplant.
Patients Should ‘Have the Conversation’ About Cannabis With Care Teams
The use of cannabis seems to be growing when it comes to mitigating side effects from cancer treatment, though it is important that patients talk to their providers if they are using these products or have questions about them, explained Dr. Brooke Worster from Thomas Jefferson University.
I recently spoke to Woster about the conversations patients with cancer should be having if they’re using or considering using cannabis. Namely, she discussed seeking guidance and having open discussions with the care team, but also remembering that cannabis is not a proven cure for any kinds of cancer.
Drug Gets Breakthrough Therapy Designation for HER2-Mutant Lung Cancer
A novel drug, BAY 2927088 received a breakthrough therapy designation for treating HER2-mutant non-small cell lung cancer. This designation, granted by the FDA, signifies a potential advancement in treatment options for patients with this specific type of lung cancer, which happens in approximately 2% to 4% of advanced NSCLC cases. Now that the drug has a breakthrough therapy designation, its review will be fast tracked.
BAY 2927088, an oral tyrosine kinase inhibitor, has shown promising results in a phase 1 trial, with a focus on safety, efficacy and patient outcomes. The drug works by blocking HER2, which can contribute to lung cancer proliferation.
Hispanic/Latino Survivors May Be Higher Risk for Cardiometabolic Comorbidities
A recent study found that Hispanic/Latino cancer survivors have higher rates of cardiometabolic comorbidities — meaning health conditions that affect the heart and/or metabolic system — such as diabetes, hypertension and heart disease, which can complicate cancer treatment and post-treatment health management.
The study showed that survivors with cardiometabolic conditions experienced lower health-related quality of life and had unmet supportive care needs, particularly in terms of emotional and physical well-being. The research also found that socioeconomic factors, such as income levels, were also linked to the prevalence of cardiometabolic conditions among Hispanic/Latino survivors, highlighting the importance of access to health care and healthy lifestyle behaviors in managing these health challenges. The study emphasized the need for holistic approaches to health that consider environmental influences and support policies promoting heart-healthy behaviors within communities.
Trial Evaluates Reduced Chemo Post-Stem Cell Transplant in Blood Cancers
Patients with blood cancers can talk to their cancer care team about possible enrollment in the OPTIMIZE trial, which is investigating a lower dose of post-transplant cyclophosphamide — also referred to as “PTCy” — to reduce infection risk post-stem cell transplant while preventing graft-versus-host disease in patients who underwent a stem cell transplant from a partially matched unrelated donor.
This phase 2 trial aims to enroll 190 patients across cancer centers across the United States, and is expected to conclude in June 2026. By exploring reduced PTCy dosages, researchers hope to enhance patient survival and quality of life by minimizing toxicities associated with standard dosing.
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Last week, the Food and Drug Administration (FDA) approved four different therapies in the oncology space — one of which, Amtagvi, marks the first cellular therapy for the treatment of solid cancers.
The week’s first approval (an Onivyde regimen for metastatic pancreatic cancer) was covered in last week’s episode, but here’s a list of what has happened since that last recording.
FDA Approves Tepmetko for Metastatic NSCLC Subtype
Patients with metastatic non-small cell lung cancer that has MET exon 14 skipping alterations may soon have a new treatment option, as the FDA approved Tepmetko in this indication.
Notably, this full approval is coming three years after the agency’s accelerated approval of the agent back in February 2021. Follow-up clinical trial data showed that 57% of previously untreated patients responded to therapy with Tepmetko, with 40% having a duration of response that lasted a year or longer.
FDA Approves Amtagvi for Pretreated, Advanced Melanoma
On Feb. 16, the FDA approved Amtagvi for patients with advanced melanoma who had previously been treated with an immunotherapy or targeted therapy. Notably, Amtagvi is a cell-based therapy and is actually the first cell-based treatment to be approved in the solid tumor space.
According to trial results that led to the approval, 31.5% of patients responded to therapy. Now this is a pretty exciting number, considering that this heavily pretreated population tends to have low response rates. Not to mention, TIL therapies like Amtagvi — while upfront they require about a three-week hospital stay — may set patients up for years without having to undergo more treatment, according to Dr. Rodabe Amaria from The University of Texas MD Anderson Cancer Center, who I spoke with after the approval.
Tagrisso Plus Chemo Approved by FDA for EGFR-Mutated NSCLC
In the lung cancer space, we saw the approval of Tagrisso plus platinum-based chemotherapy for patients with locally advanced or metastatic non-small cell lung cancer whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations.
Findings from the FLAURA 2 trial led to this approval, as data showed that progression-free survival was 25.5 months for patients who received Tagrisso plus chemotherapy, compared to 16.7 months for patients who received Tagrisso alone. Overall survival data is still immature at this point — meaning that the researchers just don’t have enough data to calculate averages — so stay tuned for more on that.
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Last week, we saw some FDA approvals for a new drug regimens, as well as some expert opinion about cancer vaccines. Additionally research touched upon the potential benefit of concurrent ctDNA and tumor testing, and physical activity for pain reduction in cancer survivors.
FDA Approves Onivyde as First-Line Treatment of Metastatic Pancreatic Cancer
On Tuesday, the Food and Drug Administration approved Onivyde plus oxaliplatin, fluorouracil and leucovorin — a regimen referred to as NALIRIFOX — for the frontline treatment of patients with metastatic adenocarcinoma. The approval was based on findings from the NAPOLI 3 trial, which showed that the drug combination improved overall survival (which is the time after treatment patients live before death of any cause) and progression-free survival (time they live before their disease worsens) compared to a combination of gemcitabine plus nab-paclitaxel.
While this approval provides a new, promising treatment for this patient population, Dr. Anthony Shields of the Karmanos Cancer Center in Detroit mentioned that the Onivyde-containing regimen is not a cure.
“In our patients with advanced disease, this is not a curative therapy at this point,” Shields said in an interview with CURE®. “It clearly improves survival. It's still got its share of toxicities, though. … We need better drugs, despite the improvements. If patients get this regimen is the first line, inevitably if they're doing OK we will give gemcitabine/nab-paclitaxel (combination) as the second-line regimen. But we really don't have a third line regimen.”
Cancer Vaccine Could Go ‘Above and Beyond Standard of Care’ For Patients
The oncology community is on the cusp of a sea change regarding cancer vaccines, as one expert told us.
“Current vaccines have a dismal record, and minimal evidence of efficacy,” said Dr. Jeffrey S. Weber, deputy director of the NYU Langone Perlmutter Cancer Center and Laura and Isaac Perlmutter Professor of Oncology at NYU Grossman School of Medicine, via email.
Weber was among the researchers on recent KEYNOTE-942 study investigating mRNA vaccine mRNA-4157 (V940) and Keytruda versus standalone Keytruda for the treatment of patients with advanced-stage melanoma.With a median follow-up of 23 and 24 months, the recurrence or death rates were 22% and 40% and the 18-month recurrence-free survival rates were 79% and 62%, respectively.
The Food and Drug Administration (FDA) granted Breakthrough Therapy Designation to the combination for the post-surgical treatment of patients with high-risk melanoma in 2023 based on the results of KEYNOTE-942.
“This mRNA vaccine would be the first approved cancer vaccine with clear cut evidence of efficacy in a well-done phase 3 trial [which was recently initiated],” Weber said of mRNA-4157.
Pharmaceutical companies Moderna and Merck have initiated V940-001, a phase 3 study evaluating mRNA-4157 and Keytruda as postsurgical treatment for stage 2B to 4 melanoma, announcing in June of 2023 that global patient recruitment had begun following primary analysis of the findings of KEYNOTE-942.
Tumor Testing, ctDNA Finds More Patients Eligible for Personalized Drugs
Circulating tumor DNA and tumor tissue-based testing can both help identify cancer characteristics that may point a patient toward a more targeted treatment regimen. Oftentimes, patients undergo only one of these two tests, but recent research showed that undergoing both of these tests may improve patients’ chance of identifying targetable mutations.
Now, some patient populations — such as those with non-small cell lung cancer — may already be undergoing both tests in accordance with NCCN guidelines. The findings support that other groups in particular, such as those with breast cancer, may benefit from the dual testing modality.
In an interview with CURE, one of the study authors noted that the two tests can be “highly complementary,” and patients should talk to their health care teams about which test to undergo.
Physical Activity May Help Reduce Pain in Cancer Survivors
Increased physical activity may be able to lessen pain in cancer survivors, according to one study.
Specifically, the researchers wrote, “Meeting or exceeding physical activity guidelines was associated with less pain intensity compared to being physically inactive. People who remained active longer term, were previously physically active or became active also reported less pain than those who remained inactive.”
These benefits were also seen in patients who were previously active but then became inactive — highlighting the possibility that the when it comes to pain reduction, the benefits of being active can stretch long-term. But interestingly, the was no association between physical activity and painkiller use.
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Last week, we saw a few moving parts in the regulatory space, from new NCCN guidelines for pediatric neuroblastoma treatment to FDA Fast Tracks and Priority Reviews. Also last week, we covered research showing that a lower dose of an anti-emetic drug could have similar efficacy — and fewer side effects — than the standard, higher dose.
NCCN Guidelines Give Framework for Childhood Neuroblastoma Treatment
The National Comprehensive Cancer Network recently published guidelines for the treatment of pediatric patients with neuroblastoma. This resource is geared toward mitigating unnecessary side effects and over treatment in patients with low-risk disease, while also developing the best treatment plans for high-risk patients.
CURE® spoke with Dr. Rochelle Bagatell, professor of Pediatrics and Solid Tumor Section Chief at Children's Hospital of Philadelphia, and Chair of the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Panel for Neuroblastoma, who emphasized that while these guidelines can influence treatment strategies, conversations between patient families and clinicians and even insurance coverage, each patient’s care should be as personalized as possible.
“There may be specific cases where the nuances of a particular patient's case means that you have to adjust your thinking from what's written on those nice, clear lines,” Bagatell said. “But the general guidance about how to think about the risk of recurrence, what general type of therapy would be appropriate, how much chemotherapy when to do surgery. Those are the kinds of things that patients and families can look at and bring to their doctor and discuss.”
FDA Fast Tracks ARV-471 for Metastatic Breast Cancer
Last week the Food and Drug Administration (FDA) granted a Fast Track designation to ARV-471, a novel drug being studied for the treatment of patients with ER-positive, HER2-negative locally advanced or metastatic breast cancer. Specifically, this indication of ARV-471 is for patients who previously underwent endocrine therapy.
Fast Track designations are given to drugs that show promise in treating serious conditions and fill an unmet need. The goal is to speed up the review and potential approval of these therapies.
ARV-471 is being studied in the phase 3 VERITAC-2 clinical trial, which is comparing ARV-471 to Faslodex in this patient population. Preclinical studies showed that the drug induced tumor shrinkage and degradation.
FDA Grants Priority Review for Alecensa in Some ALK-Positive NSCLC
Also in FDA news from last week, the agency granted a priority review to Alecensa as a postsurgical treatment for patients with early-stage ALK-positive non-small cell lung cancer.
The priority review is based off findings from the phase 3 ALINA trial, which showed that the drug led to a 76% reduction in the risk of disease recurrence or death compared with chemotherapy treatment. Findings from this study also showed that at two years, 93.8% of patients taking Alecensa experienced disease-free survival (which is the time after treatment when patients do not have symptoms of complications from their cancer), compared with 63% in the chemotherapy group. At three years, disease-free survival rates were 88.3% and 53.3%, respectively.
With the priority review, the FDA said that they plan on making an approval decision on Alecensa on or by May 22, 2023, though those dates can always change.
Lower Dose of Nausea, Vomiting Drug Controls Chemo Symptoms
Finally, research showed that a lower dose of a nausea and vomiting drug could be just as effective as the higher, standard dose when it comes to controlling chemotherapy-induced nausea and vomiting.
A study published in The Lancet Oncology found that a 2.5-milligram dose of olanzapine is not inferior (meaning it is no less effective) than a 10-milligram dose. Specifically, the researchers looked at the use of rescue medications, vomiting episodes and mild nausea over the course of 120 hours.
Notably, this lower dose can also lead to a decrease in side effects related to the drug, such as feeling of lethargy and drowsiness.
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Last week, we saw some research regarding how a popular tool used to plan breast cancer treatment may be misguiding therapy for Black women, as well as an update on when we can expect to see a new cancer vaccine be readily available for patients.
And on the FDA front, we’ll discuss a priority review for Enhertu for patients with HER2-positive solid cancers, as well as a fast track designation for a new drug duo in the lung cancer space.
Cancer Vaccine Likely ‘Several Years’ Away From Wide Availability
ELI-002 is a vaccine being investigated for the treatment of patients with KRAS-mutant pancreatic or colorectal cancers. While cancer vaccines have been in the headlines a lot in recent months, this one, at least, is still a ways away from being readily available for patients across the United States.
Findings from a phase 1 trial showed that the vaccine could be beneficial for this patient population, and now, a phase 2 trial recently started that will evaluate the efficacy of an injection version of ELI-002, compared to observation. The first patient was dosed in the trial in January 2024, so it could still be several more years until the drug is available, Dr. Christopher Haqq, chief medical officer and vice president, head of research and development at Elicio Therapeutics, said in an interview with CURE®.
“We'll be talking to the regulators like the US Food and Drug Administration and others around the world to align on the data that we'll need to provide for a marketing application. And so, we haven't had that input yet. So I can't give an exact answer for you (on when the vaccine will be commercially available). But we'll work as fast as possible. It's even possible that the type of evidence that we gather in this randomized study could serve that purpose. But we won't know until we have further discussion,” he said.
Test May Be ‘Misguiding’ Breast Cancer Treatment for Black Women
A recent study showed that the 21-gene breast recurrence score may lead clinicians away from prescribing chemotherapy to Black women who may benefit from the treatment.
The 21-gene breast recurrence score is the standard test to help guide treatment decisions for patients with estrogen receptor-positive (also known as ER-positive) disease. Most patients with ER-positive cancer undergo hormone therapy, but the outcomes for this test may help decide if a patient would benefit from additional chemotherapy, too. Now, findings from a recent study discovered that Black women — and younger Black women, in particular — may be missing out on chemotherapy that they could potentially benefit from.
Now, this research team is conducting further research looking at potential molecular differences in breast cancer in Black women, as well as how other social disparities could be playing into an increased risk of breast cancer death in these women.
FDA Grants Priority Review to Enhertu for HER2-Positive Solid Cancers
The Food and Drug Administration granted a priority review for a supplemental biologics license to Enhertu for the treatment of patients with previously treated metastatic HER2-positive solid tumors that cannot be removed via surgery. Basically what that means is that the drug showed promise in a clinical trial, and now the FDA will work with the pharmaceutical company developing the drug to expedite the review and potential approval of the agent. The agency plans on making its decision on whether or not Enertu will be approved some time in the second quarter of this year.
Enertu is an antibody drug conjugate, which is a type of drug that works by finding and binding to certain proteins found on cancer cells — in this case, the HER2 protein. The drug was previously approved for patients with lung cancer and metastatic breast cancer, and now, the phase 2 DESTINY-PanTumo02 trial will help determine if it will be approved for patients with endometrial, cervical, ovarian, bladder, biliary tract, pancreatic or other cancers that are HER2 positive.
FDA Grants Fast Track Designation to Avutometinib-Lumakras Combo
Also in the regulatory space, the FDA granted a fast track designation to a two drug combination consisting of Lumakras and the novel agent, avutometinib for patients with KRAS G12C-mutant metastatic non-small cell lung cancer. The intended patient population for the regimen is those who have been treated with at least one systemic therapy and have not received a KRAS G12C inhibitor.
The regimen is being investigated in the ongoing phase 1/2 RAMP 203 trial, which will analyze the effectiveness of the drug, as well as the overall response rate — which is the percentage of patients whose cancer decreases from the drug — and safety. Findings from the second phase of the trial, which is specifically looking at patients who have not received or did not respond to a KRAS G12-inhibitor are expected to be published some time in the first half of 2024.
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It’s been a busy few weeks here at CURE® and in the oncology space as a whole, as the last two weekends had back-to-back meetings: the American Society of Clinical Oncology’s Gastrointestinal Cancers Symposium, and then their Genitourinary Cancers Symposium.
Here are some highlights from the conference, but as always, you can find all of our coverage at curetoday.com.
Gastrointestinal Cancers Symposium
Imfinzi, Avastin, TACE May ‘Set a New Standard of Care’ in Liver Cancer
For patients with liver cancer whose disease is not eligible to be removed via surgery, adding Imfinzi and Avastin to transarterial chemoembolization — also known as TACE — tended to lengthen the time patients lived before their disease got worse, according to findings from the EMRALD-1 trial. These improvements in progression-free survival over TACE alone could lead to a new standard of care for this patient population, according to the lead study author, Dr. Riccardo Lencioni.
More specifically, patients who received Imfinzi and Avastin plus TACE lived for a median of 15 months before death or disease worsening, compared to 8.2 months for patients who received TACE alone. This correlates to a 23% reduction in the risk of disease progression or death, and benefits were seen across different patient subgroups.
Notably, the researchers on EMRALD-1 are still monitoring how the addition of the two drugs impacts overall survival. Once those data become more clear, it is possible that the drug manufacturers could submit this regimen to the FDA for approval, thereby officially shaking up the standard of care of TACE, which has remained the main treatment in this setting for about two decades.
Cancer in Bloodstream May Predict CRC Outcomes
Circulating tumor DNA — also known as ctDNA — was another hot topic at the Gastrointestinal Cancers Symposium. So ctDNA measures little fragments of cancer that are found in the bloodstream after cancer treatment.
Now, findings from the BESPOKE trial highlight the fact that ctDNA may offer insight into the recurrence risk in patients with stage 2/3 colorectal cancer who underwent surgery and then chemotherapy. The researchers used ctDNA to help determine minimal residual disease, or MRD, status. Essentially, patients with disease still detected in the blood stream were MRD positive, while those without detectable cancer were MRD negative. Findings showed that those with MRD negativity tended to live longer without experiencing relapse or death compared to patients with MRD positivity.
Genitourinary Cancers Symposium
Survival Benefits with Keytruda and Padcev in Advanced Urothelial Cancer
Back in December, the Food and Drug Administration approved Padcev plus Keytruda for patients with previously treated locally advanced or metastatic bladder cancer. The approval was based on primary findings from the EV-302 trial. Now, updated findings from that trial are showing that the drug duo continues to outperform chemotherapy when it comes to progression-free survival — that’s the time patients live before their disease gets worse — as well as overall survival, which is the time patients live before death of any cause.
Notably, these survival benefits were seen across patient subgroups, such as those with visceral metastases and lymph node-only disease. According to the lead study author, Dr. Michiel S. Van Der Heijden, this could result in a new standard of care in patients with locally advanced or metastatic urothelial carcinoma.
Many Patients Miss Out on Testing to Guide Prostate Cancer Treatment
On the prostate cancer front, a study found that many people with metastatic castration-resistant prostate cancer are not undergoing germline or somatic testing. Now this is really important because back in 2020, two PARP inhibitors were approved in this setting. These are targeted drugs approved for patients whose cancers have certain characteristics, which can be determined by these types of tests.
Rates of germline and somatic testing have increased since the FDA approvals, but according to the study — which looked at real-world evidence of patients being treated in community cancer and urology centers — about 40% of patients did not undergo standard-of-care testing.
Study author, Dr. Neal Shore, said that this indicates the need for improved education on the importance of germline and somatic testing.
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Last week, we saw some big headlines in the oncology space, from Dexter Scott King’s death from prostate cancer and MLB Hall-of-Famer Ryne Sandberg announcing that he was diagnosed with the disease.
The FDA also requested a label update for CAR-T cell therapies that would warn patients and providers about secondary malignancies that have been reported from the treatment. Also, we took a look at laughter therapy, and how it could help patients and caregivers.
We’ve also been busy covering two conferences — ASCO’s Gastrointestinal Cancers Symposium, as well as their Genitourinary Cancers Symposium, so tune in later this week for a special podcast episode highlighting some major research from those events.
Dexter Scott King Dies of Prostate Cancer, Ryne Sandberg Diagnosed With the Disease
Last Monday, Jan. 22, we saw two big stories in the prostate cancer space. First, Dexter Scott King, the son of the Civil Rights activist, Martin Luther King, Jr., died of prostate cancer. He was 62 years old.
At the time of his death, King was the Chairman of the King Center, which is an organization focused on educating the world about the life and legacy of Dr. Martin Luther King Jr. Dexter Scott King was also the president of the King estate.
In a statement announcing King’s death, his wife, Leah Weber said, “He transitioned peacefully in his sleep at home with me in Malibu. He gave it everything and battled this terrible disease until the end.”
And on the same day Dexter Scott King died, Major League Baseball Hall-of-Famer, Ryne Sandberg, announced that he was diagnosed with metastatic prostate cancer.
The 64-year-old — who was a 10-time All Star during his tenure for the Chicago Cubs, which ran from 1982 to 1997 — announced his diagnosis on Instagram. He said that received the diagnosis a week earlier and has started treatment. He asked that fans keep him in their thoughts and prayers.
FDA Requests Warnings on CAR-T Cell Therapies, Citing Secondary Cancers
The investigation into CAR-T cell therapies continues. Recently, the Food and Drug Administration (FDA) requested that approved BCMA- or CD19-targeted CAR-T cell therapies update their labeling to include a warning of reports of T-cell malignancies, including CAR-positive lymphomas, which have been reported in patients who use this type of therapy.
Back in November, the FDA announced that it was investigating reports of secondary diseases in patients who underwent CAR-T cell therapy. The available data shows that these diseases are extremely rare, and researchers are still looking into what, exactly, is causing them.
Now, the FDA wrote letters to the manufacturers of five CAR-T cell therapies, requesting that they include a Boxed Warning — which is the highest safety-related warning for drugs — outlining the potential risks of CAR-T cell products. The companies must respond to the FDA within 30 days of receiving the letters, which were sent out on Jan. 19.
Laughter Therapy May Improve Mood, Decrease Pain in Patients With Cancer
And on a much lighter note, we covered recent research showing that laughter therapy can decrease mood disturbances in patients receiving palliative care for late-stage cancer, as well as their loved ones. The findings, which were published in the journal, Cancer Nursing, also found that the laughter therapy reduced pain perception in patients and decreased levels of burnout in caregivers.
Laughter therapy refers to alternative and complementary therapy using humor to help relieve stress and pain, in addition to potentially improving a patient’s sense of well-being, according to the National Cancer Institute. In this instance, it consisted of five 20- to 30-minute sessions held over five consecutive days. The participants introduced themselves using funny tools to relieve tension, and moved their bodies in laughing rhythms.
“This indicates that our palliative care patients and family caregivers would have a positive view of the use of laughter or humor in their palliative circumstances,” the researchers wrote.
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Often, receiving a cancer diagnosis can require a crash course in oncology that few patients ever expected to take.
For colorectal cancer specialist Dr. Dustin Deming, the ACI/Schwenn Family associate professor in the division of hematology, medical oncology and palliative care at UW School of Medicine and Public Health, a diagnosis of rectal cancer two weeks after receiving his first faculty appointment required an education of a different sort.
Deming, a gastrointestinal oncologist and laboratory researcher for UW Health | Carbone Cancer Center, told CURE®, needed to learn how to be a patient.
“For me, the crash course was in being able to allow my medical friends to be my doctors,” said Deming. “So, that was the part that I really had to wrap my head around. I knew what we needed to do. I knew I knew what I was about to go through. But I hadn't sat in the patient chair before. And so, the crash course that I had to enter was the crash course in what it's like to be a patient.”
Deming was 31 at the time of his diagnosis in 2012, married and with a 12-week-old daughter who he’d brought to his colonoscopy appointment. Treatment with surgery, chemotherapy and radiation followed, with Deming working as he was able to do so.
While colorectal cancer is the fourth most common cancer diagnosis in the United States, only 2% of new cases occur in patients ages 20 to 34, with the majority of cases (25.5%) occurring in patients ages 65 to 74, according to the National Cancer Institute.
“It’s obviously extremely ironic, and (was) potentially life-shattering at the time,” Deming said. “You know, when I was diagnosed, I had a 12-week-old daughter who came to the colonoscopy with me. Getting that kind of news at 31, I don't think anybody's prepared for. Having been a colon cancer doctor and researcher was helpful in that it provided me in insight into what we needed to do. But it was also terrifying, in that I knew all the dirty secrets.”
After being cancer-free for eight and a half years, Deming experienced a recurrence in 2020. He received further chemotherapy, radiation and surgery, followed by a second recurrence about a year later that was treated with surgery and chemotherapy. Approximately 10 months after his latest surgery, he has no evidence of cancer.
Dustin spoke with CURE’s “Cancer Horizons” podcast about his cancer journey, the connections it’s created with his patients and his continuing dedication to treating others.
“Having been a patient myself, I feel like — now, I don't know how it feels for each individual patient, but I know how it feels for me — I know how it feels to hear the ‘cancer’ word, I know how it feels to have to go through chemo, radiation and multiple surgeries,” Deming said. “So, every time I meet a patient for the first time, I sit down and tell the patients kind of where I've been so that they know where I'm coming from and also (to) make sure that they know that I now get it and that I'm actually truly honored to be part of the team helping take care of them.
“I know what it means to trust oncologists with your care, and I'm so glad that I'm here to be able to help more patients.”
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It wasn’t even two weeks into the new year when the Food and Drug Administration made their first FDA approval. In this case, it was a Keytruda regimen for certain patients with gynecologic cancers. We at CURE® spoke with an the primary investigator on the study leading to the approval about what patients need to know about the latest new indication.
Also last week, we highlighted the Lymphedema Treatment Act and spoke to an expert about the new law.
Another story in the regulatory space: the FDA granted a Fast Track designation to speed up the review of a novel drug used to treat patients with relapsed or refractory CLL or SLL.
Finally, research from the American Cancer Society showed that Medicaid expansion states tended to have improved post-surgical outcomes in patients with non-small cell lung cancer.
Keytruda Plus CRT Offers ‘Better Chance of Cure’ in Advanced Cervical Cancer
The Food and Drug Administration has granted approval for Keytruda (pembrolizumab) in combination with chemoradiotherapy for the treatment of stages 3 to 4A cervical cancer, marking the first approval of an anti-PD-1 therapy with chemotherapy for this patient population and the third FDA approval for treating cervical cancer with Keytruda.
This week, I spoke with Dr. Linda R. Duska, a gynecologic oncologist and principal investigator on the study leading to the approval, who discussed the KEYNOTE-A18 trial, which enrolled 1,060 patients and demonstrated a 30% decrease in progression for those receiving the combination of Keytruda and chemotherapy. The overall survival data is not yet mature, but the treatment showed a 41% reduction in the risk of disease progression or death. While Dr. Duska emphasized that cervical cancer is preventable thanks to a safe and effective vaccine, she said that for patients with the disease, this new regimen is particularly exciting.
January is also Cervical Cancer Awareness month, so definitely stay tuned to curetoday.com for more of our coverage on the disease.
Medicare Must Now Cover Lymphedema Treatment Garments
The Lymphedema Treatment Act, signed into federal law on Dec. 23, 2022, is now in effect as of Jan. 1, 2024, allowing Medicare coverage for doctor-prescribed compression supplies for patients experiencing. The bill encompasses standard and custom-fitted gradient compression garments and other approved items prescribed by healthcare professionals to treat lymphedema. Now basically what that means is that patients insured by Medicare Part B can now have their lymphedema garments covered by insurance.
This coverage is expected to ease financial burdens on patients, especially as these garments can be expensive.
I spoke with Joanna Fawzy Doran, CEO of Triage Cancer, who emphasized the importance of patient and provider awareness about coverage rights, appealing denials and navigating the process. Although the law does not mandate private insurers to cover compression sleeves for lymphedema patients, Doran noted that Medicare's coverage sets a precedent for broader access in the future.
FDA Grants NX-5948 Fast Track Designation for R/R CLL, SLL
The FDA has granted Fast Track designation to NX-5948, a novel drug, for adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma who have previously undergone two lines of therapy, including a BTK inhibitor and a BCL2 inhibitor.
Fast Track designation aims to expedite the development and review of drugs addressing serious conditions with unmet medical needs.
NX-5948 is currently in a Phase 1a/1b clinical trial, with initial findings presented at the 2023 American Society of Hematology (ASH) annual meeting indicating safety, tolerance, and clinical activity. The drug showed no dose-limiting toxicities or treatment-related side effects leading to discontinuation, and the most common side effects were purpura/contusion, nausea, and thrombocytopenia.
Medicaid Expansion May Decrease Early Mortality in Some With NSCLC
States with Medicaid expansion tended to have a significant decrease in early, postoperative mortality from non-small cell lung cancer, according to recent research.
The research focused on nearly 15,000 patients undergoing surgery for NSCLC, with 62.1% residing in states supporting Medicaid expansion. The study found notable reductions in 30-day and 90-day postoperative mortality in patients with stages 1, 2, or 3 NSCLC in expansion states. Patients in non-expansion states were found to be younger, non-Hispanic Black, uninsured, and with comorbidities.
The study also evaluated changes in early mortality before and after the Affordable Care Act (ACA) implementation, showing a decrease in the 30-day mortality rate in expansion states from 0.97% to 0.26% after the ACA. Now, advocates, including the American Cancer Society, continue to emphasize the importance of expanding Medicaid eligibility to improve health outcomes.
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This week in oncology news, we saw a few decisions from the Food and Drug Administration, ranging from the agency agreeing to review a drug and potentially grant it a full approval to their citing manufacturing concerns for a gastric cancer drug.
Additionally, a small study showed 100% disease control rate in a subtype of non-Hodgkin lymphoma, and a clinical evaluation of a new prostate cancer drug will continue to enroll patients.
FDA Accepts sBLA For Tivdak in Recurrent or Metastatic Cervical Cancer
The Food and Drug Administration has accepted a supplemental Biologics License Application (sBLA) to Tivdak for the treatment of patients with recurrent or metastatic cervical cancer that has progressed after first-line therapy. Tivdak, the first antibody-drug conjugate for this patient population, received accelerated approval in 2021. Now, the sBLA is for the continued approval, which is contingent upon clinical benefit verification in confirmatory trials.
Results from the phase 3 innovaTV 301 trial presented at the 2023 ESMO Congress demonstrated that Tivdak reduced the risk of death by 30% compared to chemotherapy as a second- or third-line treatment for this patient population. The trial also showed improvements in overall survival, progression-free survival, and confirmed objective response rate. Treatment-related side effects were observed in a majority of patients, with anemia and nausea being the most common.
The FDA plans on making a decision on the approval by May 9, 2024.
FDA Cites Manufacturing Concerns in Missed Gastric Cancer Drug Deadline
Also in FDA news from the week, the agency will not meet the Jan. 12, 2024, deadline for approving zolbetuximab, a drug designed for the treatment of unresectable or metastatic HER2-negative, CLDN 18.2-positive gastric or gastroesophageal junction adenocarcinoma.
The FDA attributed the delay to "unresolved deficiencies following its pre-license inspection of a third-party manufacturing facility" and issued a complete response letter to Astellas, clarifying that no clinical concerns, including safety and efficacy, were identified.
Zolbetuximab, a monoclonal antibody targeting the CLDN 18.2 protein overexpressed in certain gastric cancers, has shown promise in preclinical studies by inducing cell death in cancer cells. The drug had received a priority review from the FDA based on positive outcomes in the phase 3 SPOTLIGHT clinical trial and the GLOW clinical trial. Astellas, the manufacturer of the drug, is now collaborating with the FDA and the third-party manufacturer to address the identified issues and establish a timeline for resolving them.
Enrollment Continues in Study Evaluating ONCT-534 For Advanced Prostate Cancer
Patients are still being enrolled in an assessment of the novel drug, ONCT-534, for the treatment of advanced prostate cancer that has relapsed or is refractory to approved androgen receptor pathway inhibitors (ARPIs).
The study's first two cohorts received daily oral doses of 40 mg and 80 mg of ONCT-534, while the third and fourth patients, part of the third cohort, will be administered a 160 mg daily oral dose.
The ongoing phase 1/2 ONCT-534-101 study aims to determine the drug's safety, tolerability and preliminary antitumor activity, with a total of 27 patients in the first phase and two cohorts of 16 patients each in the second phase.
The study is anticipated to conclude in January 2028.
Novel Drug Shows 100% Disease Control Rate in WM
And finally, a novel drug, iopofosine I 131, showed a 100% disease control rate in patients with Waldenstrom’s macroglobulinemia, according to topline findings from the CLOVER WaM study.
The CLOVER WaM trial investigated iopofosine I 131 in 50 WM patients who had undergone at least two prior lines of therapy, including a BTK inhibitor. In an efficacy evaluable population of 41 patients who received a total dose of 60 mCi 60 or more days ago, the trial met its primary endpoint with a major response rate of 61%. The overall response rate in evaluable patients was 75.6%, with 100% experiencing disease control and 76% not experiencing disease progression at an average follow-up of eight months. Notably, 8% of patients achieved a stringent complete remission.
Now we should note, however, that this is a small study sample size of only 50 patients, so we would expect to see future studies evaluating this drug in a larger patient population.
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Kate Rice is proof of the power of persistence and positivity while navigating a cancer journey.
Rice, an award-winning journalist, received a diagnosis of stage 4 anaplastic thyroid cancer in October 2021 — and quickly applied the same dogged dedication that had served her reporting in support of her own survival.
“When I was a reporter, none of my sources or desired sources could escape me. Sooner or later, they were going to have to talk to me, I just have that kind of determination,” Rice said. “And it wasn't so much that I wanted to find out about the cancer I got diagnosed with; I wanted to find out who could cure it.”
Years before receiving her thyroid cancer diagnosis, Rice had learned there were what doctors described as “indeterminant” nodules on her thyroid and was told to monitor them. She noticed small lumps on her neck in June 2021 and was told she would have to wait six months or so to be examined.
Rice, who had previously had a benign tumor removed from her neck and a case of melanoma, searched for doctors who could see her sooner — and, upon finally receiving her diagnosis, was told “I’ll pray for you” by a surgeon.
Anaplastic thyroid cancer, according to the American Thyroid Association, occurs in less than 2% of patients with thyroid cancers, but it is one of the fastest-growing and most aggressive of all cancers overall. The disease’s average survival rate is six months, and just approximately one-fifth of patients live longer than a year after receiving a diagnosis.
Immediately after receiving her diagnosis, Rice began sourcing for potential solutions, starting with a group text to her inner circle of loved ones.
“My cousin, who had been one of the first people I'd sent (a message to when I) cast that wide net out to try to get information, had promptly gone online and found that (The University of Texas) MD Anderson Cancer Center in Houston had a clinic that specialized in this very rare (cancer) … and actually cured people with it. So, I got my diagnosis, I think, at two o'clock Friday afternoon, I was walking home up Columbus Avenue, I guess, and on the phone with MD Anderson, to get in there because I can jump on the phone with both feet.”
Within days of receiving her diagnosis, Rice left New York City for Houston, Texas, seeking treatment from the Facilitating Anaplastic Thyroid Cancer Specialized Treatment Team at MD Anderson Cancer Center.
Such determined self-advocacy, Rice said, is “absolutely essential.”
“You have to stand up for yourself, you have to recognize that your doctors are specialists in whatever it is they're specialists in, but you're the specialist in your body,” she said. “And I knew something was going on. I mean, something was happening with my thyroid. Thyroid cancers, in general, are not the scariest cancers out there. They’re serious cancers, and the treatment for a whole bunch of different thyroid cancers is not fun. But I knew this was something that was potentially a very big deal.
“And so when the first doctors I saw in New York were very relaxed and I couldn't get in to see a doctor I've been seeing for years because I had what are called indeterminate nodules on my thyroid — (which are) not malignant, but (they’re) not benign, either — they were like, ‘Yeah, well, we can't get you in for six months, but that's OK,’ I'm like, ‘No, not OK.’ Even before I got the diagnosis, I was a pushy patient and we all have to do that. And the thing is, you're like, ‘Oh, I don't want to be much trouble. These guys are the pros, they know.’ But really, you've got to listen to your body and stand up for yourself.”
Following treatment at MD Anderson Cancer Center, Rice said she’s “fine.” Now a radio disc jockey and ski instructor in Park City, Utah, she returns to Houston every six weeks for immunotherapy treatments at MD Anderson. She also documented her cancer journey in the 2023 book “Cured: A Tale of Badassery.”
She has advice for fellow patients facing the long haul of a stage 4 cancer diagnosis.
“Stay positive. Realize we all have to fight this cancer trauma that understandably, many people in this country, in this in the world, carry because we've seen terrible things happen to people we love, when my dad died of prostate cancer,” Rice said. “But, the thing to remember is so many cancers now are either curable or treatable and manageable. The whole thing is getting to the right place in time, which is a challenge with our healthcare system. But you really have to remember there is no such thing as false hope there is only hope.”
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The year 2024 is now underway. After a busy 2023, we’re now looking back at some of the oncology headlines from the new year.
Notably, we have a clinical trial hold for a lung cancer drug, a trial that showed that a CAR-T cell therapy is cost-effective — though far from cheap — for lymphoma treatment, and a novel drug that’s showing promise for the treatment of myelofibrosis.
FDA Places Hold on Trial Evaluating TIL Therapy in NSCLC
The Food and Drug Administration placed a clinical hold on the ongoing IOV-LUN-202 trial, evaluating LN-145 TIL for patients with non-small cell lung cancer. With the clinical hold, new patients will not be able to enroll on the trial, and those who were previously treated will continue to be monitored.
The FDA placed the hold on the trial after the death of a patient. According to the FDA, the agency has the power to request that a trial be stopped, and then the sponsor — that’s the organization or company running the study — can reply via a response letter addressing the concerns. The FDA then has 30 days to respond, and potentially allow for the trial to resume.
Breyanzi Cost Effective As Second-Line R/R DLBCL Treatment
Research published in the journal, Blood Advances, found that the CAR-T cell therapy, Breyanzi, was found to be a promising and cost-effective treatment option for patients with relapsed or refractory diffuse large B-cell lymphoma — also known as DLBCL.
The study found that the incremental cost-effective ratio of the drug was just over $99,000 per quality-adjusted life-year from a health care perspective, and just over $68,000 from a societal perspective. Both these numbers are lower than the assumed social willingness to pay up to $100,000 per quality-adjusted life-year gained, as established by the American Society of Hematology.
While Breyanzi was deemed to be cost effective, CAR-T cell therapies are still far from inexpensive. In fact, the drug cost rose by 9% since its initial approval for DLBCL in 2022. In a CURE® Speaking Out® video series, Lee Greenberger, the chief scientific officer of the Leukemia & Lymphoma Society, expressed concern about the price of these drugs.
“Some of that the government is going to have to pay, some insurance is going to have to pay, but some of it the patients are going to have to pay as well. And the price tags are going to be significant. How are we going to manage that?
Phase 2 Trial Shows Fibrosis Reduction in Some With Myelofibrosis
Also in the blood cancer space, findings from the phase 2a trial found that a novel drug, GB2064, reduced fibrosis in the bone marrow, thereby slowing cancer progression in patients with myelofibrosis who were previously treated with Jakafi.
Myelofibrosis is a disease that affects the body’s production of blood cells in the bone marrow. The disease causes scar tissue to grow there — a process called fibrosis. By decreasing the amount of fibrosis that occurs, GB2064 has the potential to improve outcomes. For this patient population.
However, we should note that this trial was completed in only a small number of patients — 10, to be exact. Six patients had a decrease of fibrosis after receiving GB2064 for six months.
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The year 2023 has come and gone, and we figured that now is the perfect time to look back on some of the top cancer-related stories from the year.
Vitamin D May Impact Colorectal Cancer Outcomes
In June, we spoke to an expert about research that analyzed 14 studies on vitamin D and colorectal cancer outcomes. Findings showed that people who had a vitamin D deficiency tended to have poorer mortality outcomes than those who supplemented with vitamin D.
Laura Bolte, of the department of gastroenterology and hepatology at the University of Groningen and University Medical Center Groningen, explained that the use of corticosteroids and being underweight or malnourished — which are all things that can happen during cancer treatment — can increase the risk of vitamin D deficiency, so it is essential that patients speak with their health care team to determine if a vitamin D supplement will be appropriate and beneficial to them.
Jimmy Buffett Dies of Cancer at 76
Every now and then, major celebrity news makes cancer headlines. On Sept. 1, “Margaritaville” singer, Jimmy Buffett died of cancer at the age of 76.
Buffett had a rare and aggressive type of skin cancer called Merkel cell carcinoma, which is much more common to spread to other parts of the body, and can be very difficult to treat if it spreads, according to the American Cancer Society.
Shortly after Buffett’s death, we spoke to Dr. Manisha Thakuria, who is the director or Merkel cell carcinoma at the Dana-Farber Cancer Institute. She said, “It's always hard to see any silver linings in losses. I am glad to see Merkel cell having a little bit of a spotlight on it, and I hope that (the media interest) will increase research funding for Merkel cell carcinoma and help more patients,” said Thakuria.
Chemo Drug Shortage Requires a ‘Holistic Solution’
Perhaps one of the biggest headlines in the cancer space from 2023 was the chemotherapy shortage. The shortage of cisplatin and carboplatin required a “holistic solution,” according to Dr. Anjan J. Patel.
In a June article, I spoke with Dr. Patel and other oncology experts about the shortage, what it meant for patients taking these drugs and what was needed from a systemic level to ensure that these types of shortages never happened again.
Patients Using Cannabis Experienced Worse Symptoms, Perceive Less Harm
Patients with cancer who use cannabis reported more severe symptoms and perceived less potential harm from cannabis than patients with cancer who did not use the drug within the last 30 days, according to study findings published this summer.
Findings showed that study participants who used cannabis experienced significantly poorer physical and social functioning as well as higher pain intensity, pain interference, fatigue and sleep disturbances.
“People are using it, we should study it, and we need to know more to be able to guide physicians and cancer patients and survivors as well,” Gregory Giordano of the department of psychology and neuroscience at the University of Colorado Boulder told CURE®
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The FDA is certainly staying busy as 2023 comes to a close, approving three treatments for patients with cancer last week alone.
Additionally, exciting study findings were released regarding a cancer vaccine for the treatment of melanoma.
FDA Approves Iwilfin for High-Risk Neuroblastoma in Adults and Children
The FDA approved has Iwilfin (eflornithine) for the treatment of adult and pediatric patients with high-risk neuroblastoma who have shown at least a partial response to a previous multiagent modality therapy, which includes anti-GD2 immunotherapy.
Notably, the FDA reported that this drug is the first approval of a therapy used to reduce the risk of relapse in children with high-risk neuroblastoma. Neuroblastoma, as the National Cancer Institute explained on its website, is a cancer of immature nerve cells that most typically occurs in children, and often begins in the adrenal glands.
The FDA said the major efficacy outcome measure behind the approval was event-free survival (EFS; time after treatment when cancer does not come back or worsen; disease progression), while other notable findings included overall survival (OS; length of time from diagnosis or start of treatment when a patient is still alive).
FDA Approves Welireg for Advanced Kidney Cancer Subtype
The FDA approved Welireg ((beluztifan) for patients with advanced renal cell carcinoma (RCC) who have been previously treated with a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor, and a vascular endothelial growth factor tyrosine kinase inhibitor (VEGF-TKI).
The approval was based on findings from the LITESPARK-005 trial. Trial findings presented earlier this year at the European Society of Medical Oncology Annual Congress (ESMO) showed that at a median follow-up of 18.4 months, patients treated with Welireg experienced objective response rates (patients whose disease responded partially or completely to treatment) of 21.9%, compared with 3.5% among patients treated with Afinitor (everolimus), and 12-month progression-free survival (PFS; the time a patient lives without their disease spreading or
worsening) rates were 33.7% on Welireg versus 17.6% with Afinitor, and 18-month PFS rates were 22.5% and 9%, respectively.
FDA Approves Padcev-Keytruda Combo in Advanced Bladder Cancer
The FDA has additionally approved Padcev (enfortumab vedotin-ejfv) plus Ketruda (pembrolizumab) for patients with locally advanced or metastatic bladder cancer. Alongside this, the FDA previously granted an accelerated approval for this patient population who are unable to be treated with cisplatin-containing chemotherapy.
In the recent EV-302/KN-A39 trial, both OS and PFS showed significant improvements among the Padcev plus Keytruda group of patients, as the median overall survival for these patients was 31.5 months, while a cohort treated with chemotherapy experienced a median OS of 16.1 months.
Regarding progression-free survival, the median was 12.5 months for the Padcev-Keytruda combination group and 6.3 months in the chemotherapy group.
Cancer Vaccine Plus Keytruda Reduces Risk of Recurrence or Death in Melanoma
Patients with advanced-stage melanoma continue to experience reduced risk of recurrence or death following treatment with a combination of mRNA vaccine mRNA-4157 (V940), an investigational individualized neoantigen therapy (INT), and Keytruda, according to recent study findings.
The mRNA-4157 (V940) and Keytruda combination reduced the risk of recurrence or death by 49% and the risk of distant metastasis or death by 52% when compared with treatment with Keytruda alone in patients with stage 3 or 4 melanoma with high risk of recurrence following complete resection, as determined by the phase 2b KEYNOTE-942/mRNA-4157-P201 study, according to a news release from drug manufacturers Moderna and Merck.
The latest findings, from a median planned follow-up of approximately three years, build on previously announced primarily analysis data from a median planned follow-up of approximately two years which showed that the combination reduced the risk of recurrence or death by 44% and the risk of distance metastasis or death by 65% when compared with Keytruda alone.
Based on the trial’s findings, the Food and Drug Administration (FDA) granted Breakthrough Therapy Designation to the combination for the post-surgical treatment of patients with high-risk melanoma earlier this year.
Moderna and Merck have also announced the phase 3 INTerpath-001 (V940-001) clinical trial to evaluate the combination as an adjuvant treatment for patients with resected, high-risk stage 3B to 4 melanoma, which is currently enrolling participants, as well as a phase 3 trial for the treatment of patients with non-small cell lung cancer treated with the combination regimen.
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This past weekend, the CURE® staff was busy covering the American Society of Hematology (ASH) Annual Meeting.
ASH is the largest blood cancer conference in the country, and thousands of abstracts were presented. Now, we’re bringing you some of the highlights from the conference.
And, to view all of our conference coverage, be sure to check out curetoday.com/conference
Navitoclax Plus Jakafi Improves Spleen Volume Reductions in Myelofibrosis
Spleen enlargement is a common and often problematic symptom of myelifbrosis. However, recent findings from the phase 3 TRANSFORM-1 trial found that combining the novel drug, navitoclax with Jakafi was successful in reducing spleen volume in this patient population.
The main outcome that the researchers were looking at in this study was the percentage of patients who had a spleen volume reduction of 35% or more at certain time points. Findings showed that by week 24, 64.2% of patients who had the navitoclax regimen experienced this level of spleen reduction, compared to only 31.5% of patients who received placebo plus Jakafi — that’s a significant overall difference of 31%.
Navitoclax is not currently approved in any indication, but AbbVie, the pharmaceutical company behind the agent, plans to submit the drug for FDA approval in 2023, pending study results.
Brukinsa Lengthens Time to Progression in Relapsed/Refractory CLL, SLL
There are currently three BTK inhibitors for the treatment of chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL and SLL, respectively), though a lack of research exists that compares these drugs head-to-head.
Now, the phase 3 ALPINE trial was the first study to directly compare two BTK inhibitors, Brukinsa and Imbruvica, in patients with relapsed or refractory CLL or SLL. Findings showed that after about 39 months of follow-up, patients given Brukinsa tended to live longer before death or disease progression — a statistic experts refer to as “progression-free survival.” In the general patient population, Brukinsa reduced the risk of disease progression by 32%, and for patients with 17p deletion and/or TP53 mutations — subtypes that typically indicate aggressive disease — there was a 48% reduction in the risk of disease progression.
Abecma May Improve Quality of Life in Previously Treated Myeloma
The phase 3 KarMMA-3 trial showed that Abecma significantly improved symptoms, functioning and health-related quality of life in patients with relapsed or refractory multiple myeloma who previously underwent two to four prior treatments.
Abecma is a CAR-T cell therapy, which is a newer type of treatment for blood cancers. It involves taking patients’ blood out, and re-engineering their T cells to find and fight cancer. After they’re multiplied, those new T cells are infused back into the patient.
Findings from the KarMMA-3 trial showed that Abecma led to improvements in fatigue and pain compared with other standard regimens in this patient population. -
The last week was a busy one for us here at CURE® and across the oncology space in general. There were two major meetings we covered: the San Antonio Breast Cancer Symposium and the American Society of Hematology Annual Meeting.
The San Antonio Breast Cancer Symposium — also known as SABCS — features breast cancer research conducted around the globe. We had editors on the ground in San Antonio, as well as back in our office covering the meeting. Here are some highlights from SABCS.
And, to view all of our conference coverage, be sure to check out curetoday.com/conference
Kadcyla Is the ‘First Therapy to Show Improved Survival’ in a Breast Cancer Subset
For in patients with HER2-positive early breast cancer that still had remaining invasive disease after undergoing neoadjuvant therapy Kadcyla outperformed Herceptin when it came to overall survival, which is the time until death of any cause, and invasive disease-free survival, which is the time patients live without experience metastases or invasive disease.
The findings, which come out of the KATHERINE trial, mark the “first therapy to show an improved survival after post-surgical therapy in patients with HER2-positive early breast cancer and residual invasive disease after neoadjuvant therapy,” according to study author, Dr. Sibylle Loibl, who presented the findings at SABCS.
More specifically, at the 8.4-year follow-up mark, 70.1% of patients in the Kadcyla group and 62% in the Herceptin group were still alive. Also at that point, 32.2% given Kadcyla did not develop invasive disease, compared with 19.7% of patients in the Herceptin group.
Keytruda, Chemo Show Early-Stage Breast Cancer Event-Free Survival Benefits
Findings from phase 3 KEYNOTE-522 trial showed that presurgical Keytruda plus chemotherapy, followed by postsurgical Keytruda led to improved event-free survival — that’s time a patient lives without complications from their disease — in patients with high-risk, early-stage triple-negative breast cancer.
At a median follow-up of 63.1 months, the five-year event-free survival rate was 81.3% with neoadjuvant Keytruda/chemotherapy followed by adjuvant Keytruda compared with 72.3% in those who received placebo/chemotherapy and then placebo. These findings, according to Dr. Peter Schmid, further support the use of this Keytruda regimen as the standard of care for this patient population.
Tecentriq Plus Perjeta, Herceptin, Chemo Does Not Improve pCR in HER2+ Breast Cancer
Another phase 3 trial — the APTneo Michelangelo — showed that adding Tecentriq and Herceptin to Perjeta and chemotherapy actually did not lead to a statistically significant improvement in pathologic complete response (that’s the disappearance of cancer) when given in the presurgical setting for patients with HER2-positive breast cancer.
The study found that while Tecentriq and Herceptin-containing regimens did lead to a higher number of pathologic complete responses, these difference between the two treatment groups was not statistically significant, meaning that the researchers could not definitively say that one therapy was the result of better outcomes.
No Racial Difference in Recurrence-Free Survival in HR+, HER2- Breast Cancer
While research has shown that Black and White patients with HR-positive, HER2-negative breast cancer tend to have different survival outcomes, research presented at SABCS found that three-year recurrence-free survival is actually comparable between the two groups.
“More aggressive treatment can improve outcomes for (patients with HR-positive, basal-type tumors), as demonstrated by improved (overall survival) in (those who) achieved pathologic complete response,” study investigators stated in the poster. “These data highlight the importance of genomic testing to help optimize treatment and reduce outcome disparities in Black women.” -
Blood cancer treatments — and one treatment type, in particular — were the point of much discussion last week. The FDA said that it is investigating instances of secondary malignancies in patients with blood cancers treated with CAR-T cell therapy. Also, the drug manufacturer for a novel CAR-T cell therapy submitted an application to introduce the treatment into the United States market.
Blood cancers will continue to be a hot topic this week, as later in the week we’ll be covering the American Society of Hematology Annual Meeting. And before that, we’ll also be covering the San Antonio Breast Cancer Symposium.
Chance or CAR-T: Expert Weighs in on FDA Investigation
One of the biggest headlines in the cancer space last week was that the Food and Drug Administration (FDA) announced that they are investigating instances of T-cell malignancies — such as CAR-positive lymphoma — occurring in patients with blood cancers that were treated with CAR-T cell therapy.
CAR-T cell therapy is a newer type of blood cancer treatment that involves extracting patients’ blood and reengineering their immune T cells to find and fight cancer. Those new T cells are then multiplied and infused back into the patient. Since the first CAR-T cell product was approved in 2017, this treatment modality has drastically improved outcomes for patients with certain types of blood cancers.
It’s worth mentioning that the FDA’s Nov. 28 report about T-cell malignancies did not definitively say that CAR-T cell therapies are directly causing secondary diseases. They also did not mention the frequency at which these T-cell malignancies are occurring. I spoke with Dr. John Lister, who said that perhaps it’s the manufacturing process that could be the root cause, but perhaps it is also just chance, as research has shown that many patients with cancer hold a higher risk of developing a second cancer. For now, we’re just going to have to wait and see what further data tells us.
FDA Biologics License Application Filed for Obe-Cel for Adult R/R B-ALL
Also in CAR-T cell therapy news, last week a pharmaceutical company submitted a Biologics License Application to the FDA for their CAR-T cell therapy, obe-cel to be used for patients with relapsed or refractory B-cell acute lymphoblastic leukemia (ALL).
When a pharmaceutical company files a Biologics License Application to the FDA, they’re essentially asking the agency to allow them to bring the drug to the market. The company submitting the drug must provide the FDA with multiple pieces of information, including findings from preclinical and clinical studies showing that the drug is safe.
In this instance, the pharmaceutical company cited data from the FELIX study, from which, early data showed that 76% if patients responded to the therapy, including 54.3% who had a complete response, meaning that their disease essentially disappeared. Now, updated findings from the trial will be presented at the upcoming ASH Annual Meeting happening next week. -
For patients with cervical cancer who are negative for high-risk human papillomavirus (HPV) with normal or low-grade cytology, a prolonged follow-up interval of six months could be offered six to 24 months after receiving fertility-sparing surgery, according to the findings of a recent study.
Researchers, writing in a study published in The Lancet Oncology, noted that patients who are negative for high-risk HPV and have normal or low-grade cytology — a type of screening that collects cervical cells to be checked for changes caused by HPV that may turn into cancer, as explained by the National Cancer Institute — make up 80% of patients who receive fertility-sparing surgery, and that a 12-month interview “seems to be safe” following two consecutive negative high-risk HPV tests and an absence of high-grade cytology, which applies to 75% of all patients who receive fertility-sparing surgery.
Current guidelines in both the United States and Europe, researchers explained, recommend a six- to 12-month interval between follow-up visits for two years after fertility-sparing surgery, with a total follow-up of five years.
Learn more: HPV Causes Multiple Cancers, Though Knowledge on the Connection Is Lagging
“The development of a tailored surveillance strategy after fertility-sparing surgery could contribute to improved efficiency of follow-up in patients with cervical cancer and subsequently reduce costs in health care,” wrote the researchers behind the population-based retrospective cohort study, which utilized data from the Netherlands Cancer Registry and the Dutch Nationwide Pathology Data Bank on more than 1,400 patients ages 18 to 40 with cervical cancer who received fertility-sparing surgery between Jan 1, 2000 and Dec 31, 2020.
Kate Weissman, a cervical cancer survivor, welcomes such research advancements.
“(It's) well overdue and certainly something that the cervical cancer community is owed, given that it's something that has not been paid attention to for so long,” she said. “It's always been really just (about) luck of the of the draw in who your oncologist is and who your team of doctors are to even discuss your fertility. So, I think that this is really long overdue, and I'm glad that the attention is on it, finally, for women.”
When Weismann received a diagnosis of stage 2B cervical cancer in 2015 at the age of 30, two years after being diagnosed with HPV, she was also told by her oncologist that she would not be able to carry children.
Kate began IVF, froze nine embryos and received treatment via 55 rounds of radiation, 17 rounds of chemotherapy and surgery before being declared cancer-free in 2016. She and her husband, Matt, eventually had a daughter, Louella, via surrogacy.
Now an ambassador for Cervivor, a community of patient advocates working with those affected by cervical cancer, and a 2023 Cervivor Champion Recipient, Weissman is also the Massachusetts State Lead Ambassador for the American Cancer Society Cancer Action Network.
Learn More: Why Patients Need to Remain Vigilant, Even When Dealing With Scanxiety
“When I ended my treatment in 2016, I was initially going for scans every three to six months. And then, after a couple of years, I was slowly able to extend those scans out, so now I go annually,” she said. “I will tell you, the anxiety is always with you. It never loosens its grip; you are always worried about (the cancer) coming back. And even though I'm lucky to only have to deal with scanxiety — as we call it in the cervical cancer community and really the cancer community in general once a year — it's really intense and I still have to keep up-to-date on my antianxiety medications and my therapy sessions and everything.
“Now that I have a child it's really made that anxiety of the cancer coming back all that more intense, and it feels like a lot more is at stake. But I am lucky that I survived, and it's a once-a-year thing for me. … I have access to a medical team that is going to always watch me and look out for me, and I'm aware of my own body and everything I need to be on the lookout for too in the years post-treatment. So, that's been certainly something that it never loosens its grip on you. Even when you find out (that) you're cancer-free, you're in this for the rest of your life.”
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