Oncologists Skeptical of Enhancing Oncology Model
Despite being largely onboard with value-based care models, oncologists speaking at the Association of Community Cancer Centers (ACCC) 2023 meeting were skeptical of the upcoming Enhancing Oncology Model (EOM) developed by the US Centers for Medicare and Medicaid Services (CMS). The EOM replaces the previous Oncology Care Model (OCM).
Positive Trial Data for AstraZeneca Lung Cancer Immunotherapy Sets the Stage for Battle with Merck’s Keytruda
Astrazeneca reported promising data for its non-small cell lung cancer (NSCLC) immunotherapy Imfinzi, setting the stage for a market showdown with Merk’s Keytruda. The therapy, when added to chemotherapy, improved event-free survival in patients undergoing surgery for early stage NSCLC. Once entering the market, the drug is set to be a strong competitor with Keytruda.
New Trial Data Sinks Astellas’ Hopes to Expand Indication for Leukemia Drug
Astellas reported new trial data for Xospata that bodes poorly for its chances at an expanded indication as an add-on in the treatment of acute myeloid leukemia (AML), an aggressive blood cancer. The data showed that addition of Xospata after stem cell therapy did not improve relapse-free survival at 2-year followup.
Bristol Myers Scraps Cancer Drug Launch in Germany Over Pricing
Bristol Myers Squibb’s (BMS) cancer drug Opdualag will not be launched in Germany for the foreseeable future, despite its EU approval last September. The decision was made due to pricing conflicts with a 2010 drug pricing law in the nation that requires evidence that a new drug has a benefit over current alternatives. While clinical trial data showed the drug to be more effective than the standard of care in treating advanced melanoma, the endpoints used are a sticking point for the Gemeinsamer Bundesausschuss (G-BA).
Moderna Optimistic About Cancer Vaccine Getting Accelerated Approval
Moderna’s president Stephen Hoge told attendees at Cowen’s Annual Healthcare Conference that the company is optimistic about its chances to snag accelerated approval for its mRNA-based personalized cancer vaccine. Hoge pointed out that data from December may not be enough, but there is enough time to generate new data that may tip the scales.
EMA Committee Recommends Regeneron’s Libtayo + Chemotherapy Combo for Lung Cancer
Regeneron’s Libtayo (cemplimab-rwlc) has received a recommendation from the European Medicine’s Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) for use in forms of non-small-cell lung cancer (NSCLC) as a combination therapy with a traditional chemotherapy agent. The recommendation comes as the company releases promising phase III clinical trial data.
FDA Grants SpringWorks’ Desmoid Tumor Drug Priority Review
The SpringWorks Therapeutics, a spinoff of Pfizer, received priority review by the US Food and Drug Admnistration (FDA) for nirogacestat as a treatment for desmoid tumors. Patients taking the small molecule drug as a monotherapy had 71% lower risk of progression and had a better objective response rate compared to placebo.
FDA Grants Breakthrough Status for Moderna and Merck’s Vaccine Combo Therapy for Skin Cancer
Moderna and Merck have secured a win with the US Food and Drug Administration (FDA) granting breakthrough therapy designation to the companies’ experimental therapy for skin cancer. The treatment combines a new mRNA vaccine with Merck’s existing drug Keytruda to help the immune system fight melanoma.
BSQ’s Abecma CAR-T Multiple Myeloma Therapy Cuts Progression or Death in Half
Bristol Myers Squibb has released positive new data from its KarMMa-3 trial for Abecma, its CAR-T therapy for multiple myeloma. The results show that patients taking Abecma instead of the current standard of care have 51% reduced risk of death or disease progression. Data also indicates that patients in the Abecma group had a median time without disease progression of 13.3 months.
Kite’s Rare Blood Cancer CAR T-Cell Therapy Improves Survival in Three-Year Followup Data
Kite has announced that its CAR T-cell therapy for relapsed/refractory B-cell acute lymphoblastic leukemia (R/R B-ALL), a rare blood cancer with low survival rates, helped improve overall survival in 3-year follow-up data. Patients given the treatment had a median survival of 26 months, with 47% of patients alive at 36 months.
Siemens Gets FDA and EU Approval for High-Performance Tumor Imaging System
The EU and the US Food and Drug Administration have given approval for Seimens’ Hypersight computed tomography (CT) imaging system. The device, meant to be paired with Seimens Varian radiotherapy systems, produces large, high-contrast images of tumors and surrounding organs in seconds.
FDA Approves Two New Treatments for Breast Cancer and Lymphoma
Eli Lilly and the Menarini Group have both gotten the nod from the US Food and Drug Administration (FDA) for their new cancer medications. Lilly’s therapeutic for relapsed or refractory mantle cell lymphoma, called Jaypirca, is only the fourth drug of its kind approved by the agency. It will cost $21,000 per month of treatment.
Bristol Myers Reveals Positive Phase II Data for Leukemia CAR-T Cell Therapy Breyanzi
Bristol Myers Squibb has announced new clinical trial data for its leukemia CAR-T cell therapy Breyanzi. The data shows that the therapy has met its primary endpoint in the treatment of patients with relapsed or refractory chronic lymphocytic leukemia (CLL), beating standard care in complete response rate. Bristol Meyer intends to present the data at an upcoming conference.
J&J and Legend’s CAR-T Therapy Better Than Standard Care in Phase III Trial
J&J and Legend Biotech have announced new results from their CARTITUDE-4 trial that shows their new CAR-T therapy Carvykti is more effective at treating multiple myeloma than standard care. The companies say that the therapy, which many predict to be an upcoming blockbuster, has achieved the trials primary endpoint of progression-free survival.
Oncology Telehealth Cuts Costs for Some Patients
A newly published paper in JAMA Network Open shows that some cancer patients saved significantly on travel costs by using telehealth oncology services. The study looked at completed telehealth visits from 11,688 adult patients up to 65 years of age and analyzed travel costs and loss of productivity due to an in-person visit.
Real-World Data Study Shows Letrozole and Palbociclib Combo Effective for Black or Hispanic Breast Cancer Patients
Although frontline letrozole and palbociclib combination therapy did not improve survival for patients with estrogen receptor-positive, HER2-negative, advanced breast cancer in clinical trials, Black and/or Hispanic patients saw an increase in progression-free survival and overall survival. Dr. Adam Brufsky discussed the study in a talk at the San Antonio Breast Cancer Symposium.
AstraZeneca Collaborates with Qure.ai for AI-Based Lung Cancer Diagnosis Pilot Trial
AstraZeneca has announced a new team-up with Qure.ai and a UK-based clinical team in a pilot trial to test the diagnostic capabilities of Qure.ai’s qXR software in identifying lung cancer from X-ray images. The trial will be held in clinics in Greater Manchester, which is noted for having some of the highest lung cancer rates in the nation.
Real-World Data Study Finds Black and Hispanic Patients Receive Less Opioids During End-of-Life Care
A recently published study in the Journal of Clinical Oncology found that Black and Hispanic patients with cancer were significantly less likely to receive opioids during end-of-life care. In addition, the results, which came from nearly 320,000 Medicare patients 65 and older, also showed that Black and Hispanic patients were more likely to be urine screened for drug use.
Modern Segregation in US Worsens Cancer Outcomes
In a newly published JAMA Oncology paper, researchers find that people living in US counties with higher levels of racial and socioeconomic segregation face a 20% increase in mortality rates. This effect was more pronounced in lung cancer, with mortality rates spiking by 50% in the most segregated counties.
AJMC View: Balancing Cancer Treatment Innovation and Economic Burden
At The American Journal of Managed Care’s Institute for Value-Based Medicine event that took place this past October, speakers discussed the high cost of new therapeutics. A balance must be struck, according to Kevin Cohen, MD, of Optum Care, using data analytics to optimize care quality and costs.
GAO Report Finds Certain Demographics Underrepresented in Cancer Drug Trials
A newly released report from the US Government Accountability Office finds that, despite years of health equity efforts, several key demographics are routinely underrepresented in clinical trials for new cancer therapeutics. This includes people with lower-incomes, rural residents, teens, older adults, and women. In addition, people from certain ethnic and racial backgrounds are also underrepresented.
Young Adult Cancer Patients May Have Higher Survival Rates with Medicaid Expansion
A newly published study in the Journal of Clinical Oncology found that a Medicaid expansion could help improve survival rates [...]
Childhood Cancer Survivors on Public Insurance Face Barriers to Care
A recent study found that childhood cancer survivors face significant barriers of access to care when insured on public plans. The study followed patients who received care for cancer at a pediatric cancer center between the ages of 15-19. The risk of follow-up effects after transitioning to adult care are dependent on a variety of factors, so researchers employed a Transition Readiness Inventory (TRI).
Making the Most of Oncology Patient Support Programs
A variety of real-world factors play into oncology outcomes that aren’t necessarily captured or accounted for in randomized controlled trials (RCTs). Drugmakers, care providers, and other stakeholders are attempting to collect data and address these gaps in care using patient support programs (PSPs), which allow for daily reporting of symptoms and treatment compliance.
AstraZeneca’s Newest Push in Oncology RWE
The pharma giant AstraZeneca has expanded its presence in the chronic lymphocytic leukemia (CLL) space in recent years. Now, according to its VP and global medical franchise head of Hematology Carlos Doti, the company will help support these oncology therapeutic development efforts with a renewed focus using real-world evidence (RWE).
