The OncFive: Top Oncology Articles for the Week of 2/16

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 Zongertinib for HER2-Mutant Advanced NSCLC
A new drug application (NDA) seeking approval of zongertinib (BI 1810631) for use in adult patients with unresectable or metastatic non–small cell lung cancer (NSCLC) with HER2 mutations who have previously received systemic therapy was granted priority review from the FDA. The application was supported by findings from the phase 1 Beamion LUNG-1 trial (NCT04886804) in which single-agent zongertinib elicited an objective response rate (ORR) of 71% in cohort 1 (n = 75). Moreover, the 6-month progression-free survival and duration of response rates were 69% and 73%, respectively. The target action date for the application falls in the third quarter of 2025.

FDA Grants Priority Review to Dordaviprone for Recurrent H3K27M+ Diffuse Glioma
The FDA granted priority review to the NDA seeking accelerated approval of imipridone dordaviprone (ONC201) for use in patients with recurrent diffuse glioma and H3K27M mutations. The application is based on data from a compassionate use program, a phase 1 trial (NCT03416530), and three phase 2 trials (NCT03295396; NCT02525692; NCT03134131). Pooled data showed that the product induced an ORR of 20% (95% CI, 10.0%-33.7%) by RANO-HGG criteria in this patient population (n = 50). The disease control rate was 40% (95% CI, 26.4%-54.8%). Under the Prescription Drug User Fee Act, the FDA will decide on the NDA by August 18, 2025.

Neoadjuvant Nivolumab Plus Chemo Improves OS in Resectable NSCLC
Updated data from the phase 3 CheckMate-816 trial (NCT02998528) indicated that neoadjuvant nivolumab (Opdivo) paired with platinum-doublet chemotherapy resulted in a statistically significant and clinically meaningful improvement in overall survival vs neoadjuvant chemotherapy alone in patients with resectable NSCLC. Safety findings proved to be consistent with prior reports, and no new signals were reported. “This is the first and only phase 3 study of a neoadjuvant-only immuno-oncology therapy to show a statistically significant benefit in patients with resectable NSCLC,” Dana Walker, MD, MSCE, of Bristol Myers Squibb, stated in a news release.

Experts Break Down Practice-Informing Presentations From 2025 ASCO GU
The 2025 Genitourinary (GU) Cancers Symposium concluded on Saturday, February 15, 2025, after 3 days of presentations showcasing emerging data across the fields of urothelial cancer, prostate cancer, and renal cell carcinoma. In this exclusive recap article, the following experts share their most notable takeaways from the meeting: Tanya B. Dorff, MD, of City of Hope; Rohan Garje, MD, of Baptist Health Miami Cancer Institute; Robert Jones, MBChB, PhD, of Glasgow School of Medicine; Bradley McGregor, MD, of Dana-Farber Cancer Institute; Funda Meric-Bernstam, MD, of The University of Texas MD Anderson Cancer Center; and Guru P. Sonpavde, MD, of AdventHealth Cancer Institute.

Updated NCCN Guidelines Recommend HEPZATO KIT for Hepatic-Dominant Uveal Melanoma
The National Comprehensive Cancer Network has updated its Clinical Practice Guidelines in Oncology for the treatment of metastatic uveal melanoma to include HEPZATO KIT ([melphalan] for Injection/Hepatic Delivery System [HDS]) as a Category 2A treatment option for patients with hepatic-dominant uveal melanoma. The guidelines had previously limited the use of HEPZATO KIT to the treatment of patients with liver-confined metastases. “This update underscores the growing recognition of HEPZATO [KIT] as an important treatment option for patients battling this challenging disease,” Gerard Michel, of Delcath Systems, stated in a news release.