Cancer Horizons

Endometrial cancer is on the rise. Hear survivor Angélica and Eisai Inc.'s Teresa Cronin discuss the Spot Her® initiative, which empowers women to spot early signs. This episode is sponsored by Eisai.

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 [https://www.curetoday.com/view/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 [https://www.curetoday.com/view/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 [https://www.curetoday.com/view/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 [https://www.curetoday.com/view/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 [https://www.curetoday.com/view/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.   For more news on cancer updates, research and education, don’t forget to subscribe to CURE®’s newsletters here [https://www.curetoday.com/view/enews?tfa_2=CUREARTICLE&utm_source=form&utm_medium=article&utm_campaign=footer].

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 [https://www.curetoday.com/view/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 [https://www.curetoday.com/view/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 [https://www.curetoday.com/view/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 [https://www.curetoday.com/view/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.   For more news on cancer updates, research and education, don’t forget to subscribe to CURE®’s newsletters here [https://www.curetoday.com/view/enews?tfa_2=CUREARTICLE&utm_source=form&utm_medium=article&utm_campaign=footer].

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 [https://www.curetoday.com/view/fda-approves-onivyde-as-first-line-treatment-of-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 [https://www.curetoday.com/view/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 [https://www.curetoday.com/view/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 [https://www.curetoday.com/view/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.  For more news on cancer updates, research and education, don’t forget to subscribe to CURE®’s newsletters here [https://www.curetoday.com/view/enews?tfa_2=CUREARTICLE&utm_source=form&utm_medium=article&utm_campaign=footer].

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 [https://www.curetoday.com/view/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 [https://www.curetoday.com/view/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 [https://www.curetoday.com/view/fda-grants-keytruda-cancer-vaccine-combo-breakthrough-therapy-designation-for-melanoma] to the combination for the post-surgical treatment of patients with high-risk melanoma in 2023 based on the results of KEYNOTE-942 [https://www.curetoday.com/view/cancer-vaccine-plus-keytruda-reduces-risk-of-recurrence-or-death-in-melanoma]. “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 [https://www.curetoday.com/view/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 [https://www.curetoday.com/view/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.  For more news on cancer updates, research and education, don’t forget to subscribe to CURE®’s newsletters here [https://www.curetoday.com/view/enews?tfa_2=CUREARTICLE&utm_source=form&utm_medium=article&utm_campaign=footer].