FDA Approval Insights: Dostarlimab in dMMR Advanced 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, we had the pleasure of speaking with Lucy Gilbert, MD, MSc, about the FDA approval of dostarlimab-gxly (Jemperli) in patients with endometrial cancer. Dr Gilbert is a professor in the Department of Obstetrics and Gynecology and a professor in the Department of Oncology at McGill University, as well as director of Gynecologic Oncology and director of the Women’s Health Research Unit at McGill University and McGill University Health Centre in Montreal, Canada.

On February 9, 2023, the FDA granted regular approval to dostarlimab for adult patients with mismatch repair–deficient (dMMR) advanced or recurrent endometrial cancer with disease progression on or after platinum-containing therapies in any setting who are not eligible for radiation or curative surgery. This regulatory decision follows the April 2021 accelerated approval of the agent in this population.

The regular approval was backed by findings from the phase 1 GARNET trial (NCT02715284), in which the cohort of patients with dMMR endometrial cancer achieved a confirmed objective response rate of 45.4% with dostarlimab. Additionally, in the endometrial cancer cohort, the median duration of response was not reached, 85.9% of patients had responses lasting at least 1 year, and 54.7% of patients had responses lasting at least 2 years.

In our exclusive interview, Dr Gilbert discussed the significance of this approval, key efficacy data from GARNET, and how this agent bolsters the endometrial cancer treatment paradigm.

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