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:
Based on data from the phase 3 KEYNOTE-811 trial (NCT03615326), the regulatory agency awarded traditional approval to the frontline combination of pembrolizumab (Keytruda), trastuzumab (Herceptin) and fluoropyrimidine- and platinum-containing chemotherapy for use in adult patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1 with a combined positive score of at least 1. In this subset of patients, treatment with the pembrolizumab combination (n = 298) translated to a 28% reduction in the risk of disease progression or death (HR, 0.72; 95% CI, 0.60-0.87) and a 21% reduction in the risk of death (HR, 0.79; 95% CI, 0.66-0.95) vs placebo plus trastuzumab and chemotherapy (n = 296).
The FDA also approved TLX007-CDx, a next-generation prostate-specific membrane antigen (PSMA) PET imaging agent. The kit is designed for preparing gallium-68 gozetotide injection (Gozellix) for PET scans to detect PSMA-positive lesions in men with prostate cancer. It is intended for patients with suspected metastasis who are eligible to receive initial definitive therapy, as well as those with suspected recurrence indicated by elevated serum prostate-specific antigen levels. The decision was based on data from the PSMA-PreRP (NCT03368547; NCT02919111) and PSMA-BCR (NCT02940262; NCT02918357) trials. “Securing FDA approval for Gozellix is a major win for [patients with] prostate cancer, who gain enhanced access to state-of-the-art 68Ga PSMA-PET imaging," Kevin Richardson, of Telix Precision Medicine, stated in a news release.
Puxitatug samrotecan (AZD8205) elicited responses and showcased an acceptable safety profile in patients with advanced or metastatic endometrial cancer, according to updated findings from the phase 1/2a BLUESTAR study (NCT05276548). The findings, presented during the 2025 SGO Annual Meeting on Women’s Cancer, showed that when the antibody-drug conjugate was administered at a dose of 2.0 mg/kg (n = 26), it led to an objective response rate (ORR) of 34.6% and a disease control rate (DCR) of 80.8%; when given at a slightly higher dose of 2.4 mg/kg (n = 26), it led to an ORR of 38.5% and a DCR of 84.6%. “Puxitatug samrotecan is an exciting new ADC targeting B7-H4, which is expressed in approximately 73% of endometrial cancers,” Stephanie Gaillard, MD, PhD, of Johns Hopkins Medicine, stated in her presentation.
The integration of artificial intelligence–powered clinical tools is poised to transform oncology practice, and Scout, a customized large-language model, AI-powered and expert-trained search tool developed by OncLive, could provide a streamlined method to aid in treatment decision-making and identifying clinical trial opportunities for patients with cancer. “Scout could definitely have a use in clinical practice [in] reducing the time it takes to look up things such as treatment guidelines, eligible clinical trials for our patients, and the most up-to-date medications or treatment options for our patients,” Joshua Feinberg, MD, of Maimonides Medical Center, said in an exclusive interview. Test Scout today.
Avutometinib (VS-6766) paired with defactinib (VS-6063) provided clinical benefits in patients with recurrent low-grade serous ovarian cancer, according to findings from the phase 2 RAMP 201 trial (NCT04625270). In all evaluable patients (n = 109), the doublet led to a confirmed ORR of 31%, which included a 2% complete response (CR) rate and a 29% partial response (PR) rate. The ORRs in those with KRAS-mutated (n = 57) or KRAS wild-type (n = 52) disease were 44% and 17%, respectively. “These data, in combination with a tolerable safety profile, support the potential for avutometinib and defactinib as a new standard of care for women with recurrent low-grade serous ovarian cancer,” Rachel N. Grisham, MD, of Memorial Sloan Kettering Cancer Center, stated in a presentation given at the 2025 SGO Annual Meeting on Women’s Cancer.