The FDA has granted approval for Jemperli (dostarlimab-gxly) in combination with chemotherapy (carboplatin and paclitaxel) followed by Jemperli alone for the treatment of advanced or recurrent endometrial cancer in adults. This approval now includes patients with mismatch repair proficient (MMRp) or microsatellite stable (MSS) tumors.

MMRp/MSS tumors represent approximately 70-75% of endometrial cancer cases and have previously had limited treatment options. The approval was based on results from a Phase III trial demonstrating significant improvement in progression-free survival (PFS) and overall survival (OS) for patients receiving Jemperli plus chemotherapy compared to chemotherapy alone.

The trial showed a 31% reduction in the risk of death (OS) and a 16.4-month increase in median OS for the Jemperli plus chemotherapy group. The safety profile of Jemperli and chemotherapy was consistent with the known safety profiles of the individual agents.

This expanded approval provides a new treatment option for a broader range of endometrial cancer patients. It represents a significant step forward in treating this challenging cancer and offers hope for improved outcomes for many.

Source link: http://www.businesswire.com/news/home/20240726127513/en/US-FDA-expands-Jemperli-dostarlimab-gxly-plus-chemotherapy-approval-to-all-adult-patients-with-primary-advanced-or-recurrent-endometrial-cancer-as-the-first-and-only-immuno-oncology-based-treatment-to-show-an-overall-survival-benefit

Jon Napitupulu
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Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.