The OncFive: Top Oncology Articles for the Week of 4/27

May 3, 2025

The FDA issues a CRL to a glioma imaging agent, an sBLA seeking approval of an epcoritamab triplet in follicular lymphoma is planned for submission, and more.

Welcome to OncLive®’s OncFive!

Every week, we bring you a quick roundup of the 5 top stories from the world of oncology—ranging from pivotal regulatory decisions to key pipeline updates to expert insights on breakthroughs that are moving the needle in cancer care. This resource is designed to keep you informed on the latest updates in the space, in just a matter of minutes.

Here’s what you may have missed this week:

Cancer Vaccines Begin to Take Center Stage With Investigators Anticipating an Even Brighter Future

Cancer vaccines are emerging as a promising treatment approach in oncology, with both FDA-approved options and novel agents in development showing potential to prevent recurrence and improve outcomes in hard-to-treat tumors. Approved therapies like BCG for bladder cancer, sipuleucel-T (Provenge) for prostate cancer, and talimogene laherparepvec (Imlygic) for melanoma have paved the way for newer approaches like aglatimagene besadenovec (CAN-2409), which is demonstrating strong clinical responses in trials. Investigational vaccines, including mRNA-based agents like mRNA-4157 and KRAS-targeted options like ELI-002, are advancing in trials across tumor types, such as pancreatic, colorectal, lung, and melanoma. Experts believe cancer vaccines could play a transformative role in early-stage and high-risk disease by targeting micrometastatic cancer and enhancing the effectiveness of existing immunotherapies. Sign up to access this feature packed full of insights.

Neoadjuvant Dostarlimab Eradicates Disease in 82% of Mismatch Repair–Deficient Solid Tumors

Data from a phase 2 study (NCT04165772) presented during the 2025 AACR Annual Meeting showed that neoadjuvant dostarlimab-gxly (Jemperli) led to a clinical complete response (cCR) in 82% (95% CI, 72%-88%) of patients with early-stage mismatch repair–deficient solid tumors. The cCRs achieved with the agent in those with rectal cancer were 100% and 65% in those with non-rectal cancer; the respective 2-year recurrence-free survival rates were 96% and 85%. “We believe that this study provides a basis for treatment approaches and clinical trials in the neoadjuvant setting, where effective therapy can lead to responses, preserve organs, and drastically improve survivorship,” Luis Diaz Jr., MD, of Memorial Sloan Kettering Cancer Center, stated in a news release.

FDA Issues CRL to TLX101-CDx for Glioma Imaging

The regulatory agency issued a complete response letter to the new drug application seeking the approval of TLX101-CDx (18F-floretyrosine [18F-FET]; Pixclara) for use in the imaging of glioma. Telix Pharmaceuticals was informed that additional confirmatory clinical evidence is needed to support approval, although no safety concerns were noted. The company shared plans to request a meeting with the FDA to review the reasons behind the decision. “We have multiple go-forward pathways available to us, such as providing additional confirmatory data through several active clinical programs, including company-led studies,” Christian Behrenbruch, PhD, MBA, JD, of Telix, stated in a news release. “Our immediate focus is understanding the FDA’s feedback and augmenting our submission with additional data to satisfy the agency as soon as possible.”

sBLA Submission Planned for Epcoritamab/Rituximab/Lenalidomide in R/R FL

Genmab announced plans to submit a supplemental biologics license application seeking the approval of subcutaneous epcoritamab-bysp (Epkinly) paired with rituximab (Rituxan) and lenalidomide (Revlimid) for use in adult patients with relapsed or refractory follicular lymphoma who have previously received at least 1 line of therapy in the first half of this year. The application will be supported by findings from an interim analysis of the phase 3 EPCORE FL-1 trial (NCT05409066) performed by an independent data monitoring committee showed that the trial met one of its dual primary end points in the form of overall response rate (P < .0001). The toxicity profile of the regimen was aligned with what has been previously reported with epcoritamab and rituximab plus lenalidomide. No new safety signals were observed.

OncLive’s FDA Approval Report: The Regulatory Rundown for April 2025

Sign up to access this guide to all the oncologic therapeutic options cleared by the FDA in April 2025. The roundup provides everything you need to know, right at your fingertips—all the topline data that supported the decisions and expert insights detailing what they mean for respective paradigms.