The OncFive: Top Oncology Articles for the Week of 3/9

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:

Vepdegestrant Hits PFS End Point in ESR1-Mutated, ER+/HER2– Metastatic Breast Cancer

Topline data from the phase 3 VERITAC-2 study (NCT05654623) showed that vepdegestrant (ARV-471) significantly improved progression-free survival (PFS) compared with fulvestrant (Faslodex) in patients with estrogen receptor (ER)–positive, HER2-negative advanced breast cancer harboring an ESR1 mutation, following progression on CDK4/6 inhibition and endocrine therapy. Notably, the PFS benefit with the agent did not reach statistical significance in the overall study population. At the time of the analysis, overall survival (OS) data were not mature. Vepdegestrant proved to be well tolerated, with a safety profile that was consistent with prior reports. Full findings will be shared at an upcoming medical meeting and discussed with global health authorities.

Maintenance OSE2101 Plus FOLFIRI Meets Primary OS End Point in Advanced/Metastatic PDAC

The noncomparative phase 2 TEDOPAM study (NCT03806309) met its primary objective in that the neoepitope-based cancer vaccine OSE2101 (Tedopi) plus 5-fluorouracil, leucovorin, and irinotecan (FOLFIRI) significantly improved the 1-year OS rate in patients with advanced or metastatic pancreatic ductal adenocarcinoma who had not progressed after 8 cycles of leucovorin, fluorouracil, irinotecan, and oxaliplatin (FOLFIRINOX) induction chemotherapy. Moreover, minimal toxicity was observed with the combination. Additional follow-up and analyses, including translational research, are ongoing to better understand the contribution of OSE2101.

PF-07248144 Plus Fulvestrant Is Safe, Active in Pretreated ER+/HER2– Metastatic Breast Cancer

Data from the dose-expansion portion of a phase 1 trial (NCT04606446) showed that the first-in-class KIT6 inhibitor PF-07248144, when combined with fulvestrant, elicited durable responses and was safe in heavily pretreated patients with ER-positive, HER2-negative metastatic breast cancer. The combination resulted in a 37.2% objective response rate (ORR) and a 55.8% clinical benefit rate, with a median PFS of 10.7 months. Safety data showed manageable safety, with grade 1/2 dysgeusia being the most common treatment-related adverse effect (TRAE); the most common grade 3 or higher TRAE was neutropenia. Check out the rest of our coverage from the 42nd Annual Miami Breast Cancer Conference.

China’s NMPA Approves Sacituzumab Tirumotecan for Pretreated EGFR+ Advanced NSCLC

China’s National Medical Products Administration has cleared sacituzumab tirumotecan (sac-TMT) for the treatment of patients with EGFR-mutant locally advanced or metastatic nonsquamous non–small cell lung cancer after disease progression on EGFR TKIs and chemotherapy. The decision is based on findings from the phase 2 OptiTROP-Lung03 trial, which showed that sac-TMT significantly improved ORR, PFS, and OS vs docetaxel. The regulatory agency previously approved sac-TMT for use in those with unresectable locally advanced or metastatic triple-negative breast cancer in November 2024. Findings from the phase 2 OptiTROP-Lung01 study (NCT05351788) indicated that sac-TMT plus the anti–PD-L1 antibody KL-A167 led to clinical benefits across various subgroups, with manageable safety.

2024 Tumor-Agnostic Approval Cheat Sheet: T-DXd and Repotrectinib

Sign up for access to exclusive cheat sheets on the tumor-agnostic approvals of fam-trastuzumab deruxtecan-nxki (Enhertu) and repotrectinib (Augtyro). The first decision changed the field for adult patients with unresectable or metastatic HER2-positive solid tumors who previously received systemic treatment and have no satisfactory alternative options. The latter decision presented another option for those with an NTRK gene fusion who have experienced disease progression after treatment or who do not have satisfactory standard therapy and have metastatic disease or disease where surgical resection is likely to result in severe morbidity. This resource offers everything you need to know about the agents and their safety/efficacy in the many solid tumors they were evaluated in.

Interested in healthcare news beyond the realm of oncology? Check out The HCPFive, from our sister publication HCPLive.