GSK announced the European Commission has approved Jemperli (dostarlimab) in combination with chemotherapy (carboplatin and paclitaxel) for first-line treatment of adult patients with primary advanced or recurrent endometrial cancer who are candidates for systemic therapy. This approval broadens the previous indication for Jemperli plus chemotherapy in the European Union (EU) to include patients with mismatch repair proficient (MMRp)/microsatellite stable (MSS) tumours, which represent approximately 75% of patients diagnosed with endometrial cancer and who have limited treatment options.

Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D, GSK, said: “For the first time, all patients with primary advanced or recurrent endometrial cancer in the EU have an approved immuno-oncology-based treatment that has shown a statistically significant and clinically meaningful overall survival benefit. We’re proud Jemperli continues to redefine the treatment landscape for patients.”

Dr Mansoor Raza Mirza, Chief Oncologist, Copenhagen University Hospital, Denmark, and RUBY principal investigator said: “Clinicians have been waiting for years for an immuno-oncology-based option that can meaningfully improve overall survival outcomes for patients with MMRp/MSS primary advanced or recurrent endometrial cancer. The expanded approval represents a significant advance that delivers on this hope, now for patients with both dMMR/MSI-H and MMRp/MSS tumours.”

The European Commission’s approval to expand the use of Jemperli plus chemotherapy is based on results from Part 1 of the RUBY phase III trial. RUBY Part 1 is the only clinical trial in this setting to show a clinically meaningful and statistically significant overall survival (OS) benefit in the full population of patients with primary advanced or recurrent endometrial cancer, demonstrating a 31% reduction in risk of death (HR: 0.69; 95% CI: 0.54–0.89) compared to chemotherapy alone.