EMA Evaluates Jemperli-Chemo Combo For Advanced Endometrial Cancer

GSK plc (LSE/NYSE: GSK) has announced that the European Medicines Agency (EMA) has accepted its application to extend the use of Jemperli (dostarlimab) in combination with standard chemotherapy (carboplatin and paclitaxel) to all adult patients with primary advanced or recurrent endometrial cancer. The EMA's Committee for Medicinal Products for Human Use will now begin the formal review process to recommend approval to the European Commission, with a decision anticipated in the first half of 2025.

 At present, in the EU, Jemperli combined with carboplatin and paclitaxel is approved for adult patients who qualify for systemic therapy for primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR) or has high microsatellite instability (MSI-H). If this new application is approved, dostarlimab's use would be expanded to all patients with primary advanced or recurrent endometrial cancer, irrespective of their biomarker status, including those with mismatch repair proficient (MMRp) or microsatellite stable (MSS) tumors, for which there are currently no approved frontline immunotherapy treatments in the EU.

 This application is based on findings from Part 1 of the RUBY phase III trial. The trial achieved its primary goals of investigator-assessed progression-free survival (PFS) and overall survival (OS), showing a statistically significant and clinically meaningful benefit for patients treated with dostarlimab plus carboplatin-paclitaxel compared to those receiving chemotherapy alone. RUBY Part 1 is the only clinical trial to demonstrate a statistically significant overall survival benefit in this patient group. Safety and tolerability analyses from RUBY indicated that the safety profile of dostarlimab combined with carboplatin-paclitaxel was generally consistent with the known safety profiles of the individual drugs.