The OncFive: Top Oncology Articles for the Week of 2/23

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:

FDA Grants Priority Review to Perioperative Pembrolizumab in Resectable HNSCC

The regulatory agency accepted and granted priority review to a supplemental biologics license application (sBLA) seeking approval of pembrolizumab (Keytruda) as neoadjuvant treatment, continued as adjuvant therapy paired with standard radiotherapy plus or minus cisplatin, and then as single-agent maintenance in patients with resectable, locally advanced head and neck squamous cell carcinoma. The perioperative regimen significantly improved event-free survival and major pathological response rate vs adjuvant radiotherapy with or without cisplatin alone, according to data from the phase 3 KEYNOTE-689 study (NCT03765918). The target action date for the sBLA is June 23, 2025.

FDA Accepts sBLA for Nivolumab/Ipilimumab in Unresectable/Metastatic MSI-H/dMMR CRC

The FDA also accepted and granted priority review to a sBLA seeking approval of nivolumab (Opdivo) combined with ipilimumab (Yervoy) for frontline use in adult and pediatric patients at least 12 years of age with unresectable or metastatic microsatellite instability–high or mismatch repair–deficient colorectal cancer. Findings from the phase 3 CheckMate 8HW trial (NCT04008030) indicated that the doublet led to better progression-free survival (PFS) than that achieved with investigator’s choice of chemotherapy, and across all lines of therapy vs single-agent nivolumab. Under the Prescription Drug User Fee Act, the agency will decide on the application by June 23, 2025.

FDA Accepts Resubmission of Odronextamab BLA in R/R Follicular Lymphoma

A biologics license application seeking approval of odronextamab (Ordspono) in patients with relapsed or refractory follicular lymphoma following at least 2 lines of systemic treatment has been resubmitted and accepted by the FDA for review. The application is supported by findings from the phase 1 ELM-1 (NCT02290951) and phase 2 ELM-2 (NCT03888105) trials, which showed that the agent (n = 103) induced an overall response rate of 80%, which comprised a complete response rate of 74%. The prior submission received a complete response letter, which cited reasons associated with enrollment status in confirmatory trials. Since then, the mandated enrollment target for the phase 3 confirmatory OLYMPIA-1 trial (NCT06091254) has been achieved. The new target action date is July 30, 2025.

First-Line Camrelizumab Plus CDK4/6 Inhibition Boosts PFS in ERS1+ HR+ Advanced Breast Cancer

Topline findings from a planned interim analysis of the pivotal phase 3 SERENA-6 study (NCT04964934) showed that camizestrant paired with palbociclib (Ibrance), ribociclib (Kisqali), or abemaciclib (Verzenio), led to a significant improvement in PFS vs standard treatment with an aromatase inhibitor (AI) and CDK4/6 inhibitor in patients with hormone receptor­–positive, HER2-negative advanced breast cancer harboring an emergent ESR1 mutation. “The results from SERENA-6 show that switching from an AI to camizestrant in combination with any of the 3 CDK4/6 inhibitors after emergence of an ESR1 mutation delays progression of disease and extends the benefit of first-line treatment, representing an important step forward for patients, and a potential shift in clinical practice,” François-Clément Bidard, MD, PhD, of Institut Curie & UVSQ/Université Paris-Saclay, stated in a news release.

Tips for Tomorrow: What 4 Experts Wish They Knew Earlier About ADCs

In this exclusive article, the following clinicians sat down with OncLive to answer the question: “What do you wish you knew about ADCs when you were first introduced to them?”: Virginia Kaklamani, MD, DSc, of the University of Texas Health Science Center San Antonio; Rachna T. Shroff, MD, MS, FASCO, of the University of Arizona Cancer Center and University of Arizona College of Medicine; Funda Meric-Bernstam, MD, of the University of Texas MD Anderson Cancer Center; and Komal Jhaveri, MD, FACP, of Memorial Sloan Kettering Cancer Center.

Honorable Mention: OncLive’s FDA Approval Report: The Regulatory Rundown for February 2025

This is your exclusive guide to all of the oncologic treatment options approved by the FDA in February 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 clinical practice.