FDA Approval Insights: Dostarlimab Plus Chemotherapy in Advanced/Recurrent Endometrial Cancer

Welcome to OncLive On Air^®! I’m your host today, Ashling Wahner.

OncLive On Air is a podcast from OncLive^®, which provides oncology professionals with the resources and information they need to provide the best patient care. In both digital and print formats, OncLive covers every angle of oncology practice, from new technology to treatment advances to important regulatory decisions.

In today’s episode, supported by GSK, we had the pleasure of speaking with Krishnansu S. Tewari, MD, about the FDA approval of dostarlimab-gxly (Jemperli) plus chemotherapy for patients with primary advanced or recurrent endometrial cancer. Dr Tewari is a professor and chief of the Division of Gynecologic Oncology in the Department of Obstetrics and Gynecology at the University of California Irvine School of Medicine, as well as a member of the Chao Family Comprehensive Cancer Center and vice president of the Orange County Obstetrics & Gynecology Society.

On August 1, 2024, the FDA expanded the indication for dostarlimab plus carboplatin and paclitaxel followed by dostarlimab maintenance therapy to include all patients with primary advanced or recurrent endometrial cancer. This regulatory decision was backed by findings from part 1 of the phase 2 RUBY trial (NCT03981796), in which the median overall survival among all-comers who received dostarlimab plus chemotherapy (n = 245) was 44.6 months (95% CI, 32.6-not reached) vs 28.2 months (95% CI, 22.1-35.6%) among those in the placebo plus chemotherapy arm (n = 249; HR, 0.69; 95% CI, 0.54-0.89; P = .002).

In our exclusive interview, Dr Tewari discussed the significance of this approval, key efficacy and safety findings from the pivotal RUBY trial, and the next steps for evaluating dostarlimab in endometrial cancer.

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