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.   For more news on cancer updates, research and education, don’t forget to subscribe to CURE®’s newsletters here.

Here are some of the top stories from the recent Gastrointestinal Cancers Symposium as well as the Genitourinary Cancers Symposium.

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.   For more news on cancer updates, research and education, don’t forget to subscribe to CURE®’s newsletters here.

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.” For more news on cancer updates, research and education, don’t forget to subscribe to CURE®’s newsletters here.

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.  For more news on cancer updates, research and education, don’t forget to subscribe to CURE®’s newsletters here.

Last week, the FDA provided updates on two cancer therapies. In this episode, we discuss those decisions and more.

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.” For more news on cancer updates, research and education, don’t forget to subscribe to CURE®’s newsletters here.

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.   For more news on cancer updates, research and education, don’t forget to subscribe to CURE®’s newsletters here.

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® For more news on cancer updates, research and education, don’t forget to subscribe to CURE®’s newsletters here.

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. For more news on cancer updates, research and education, don’t forget to subscribe to CURE®’s newsletters here.