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GSK’s Jemperli Gains CHMP Recommendation for Expanded Use in Endometrial Cancer

NextEdge Admin

17 Dec 2024

2 min 21 sec

GSK announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended expanding Jemperli (dostarlimab) approval in combination with chemotherapy (carboplatin and paclitaxel) for first-line treatment of adult patients with primary advanced or recurrent endometrial cancer eligible for systemic therapy. This expansion includes patients with mismatch repair proficient (MMRp)/microsatellite stable (MSS) tumors, who represent 70-75% of endometrial cancer cases and have limited treatment options.

The CHMP opinion precedes a European Commission decision, expected in Q1 2025.

The recommendation is based on results from Part 1 of the RUBY phase III trial, which demonstrated significant improvements in the dual primary endpoints of progression-free survival (PFS) and overall survival (OS). Dostarlimab plus carboplatin-paclitaxel showed statistically significant and clinically meaningful OS benefits over chemotherapy alone, making it the first immuno-oncology regimen to achieve this milestone in this population. The safety profile of dostarlimab plus chemotherapy was consistent with that of the individual agents.

The RUBY OS data were presented at the Society of Gynecologic Oncology Annual Meeting on Women’s Cancer on March 16, 2024, and published in Annals of Oncology on June 9, 2024. The US FDA expanded Jemperli’s label for the same indication in August 2024.

Endometrial cancer is the most common gynecologic cancer in developed countries, with rising incidence rates. Annually, Europe sees approximately 121,000 new cases of primary advanced or recurrent disease, with 70-75% classified as MMRp/MSS.