Jemperli får utökat godkännande för avancerad endometriecancer
Jemperli (dostarlimab) tillsammans med kemoterapi får positivt utlåtande från CHMP för att utöka godkännandet till att omfatta alla vuxna patienter med primärt avancerad eller återkommande endometriecancer.
Positive opinion based on statistically significant and clinically meaningful progression-free and overall survival data from phase III RUBY trial
An expanded approval would include MMRp/MSS tumours, which represent majority of endometrial cancer cases
Approval decision expected in Q1 2025
GSK announced in December 2024, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended expanding the approval of Jemperli (dostarlimab) in combination with chemotherapy (carboplatin and paclitaxel) for first-line treatment of all adult patients with primary advanced or recurrent endometrial cancer who are candidates for systemic therapy. This would include patients with mismatch repair proficient (MMRp)/microsatellite stable (MSS) tumours, who represent 70-75% of patients diagnosed with endometrial cancer and who have limited treatment options.
The CHMP opinion is one of the final steps prior to a marketing authorisation decision by the European Commission, with an approval decision expected in the first quarter of 2025.
The application to expand the use of dostarlimab is based on results from Part 1 of the RUBY phase III trial. The trial met its dual primary endpoints of investigator-assessed progression-free survival (PFS) and overall survival (OS), demonstrating a statistically significant and clinically meaningful benefit in the full population of patients treated with dostarlimab plus carboplatin-paclitaxel versus chemotherapy alone. Dostarlimab plus chemotherapy is the only immuno-oncology-based regimen to show a statistically significant OS benefit in this patient population. The safety and tolerability analyses from RUBY showed a safety profile for dostarlimab plus carboplatin-paclitaxel that was consistent with the known safety profiles of the individual agents.
OS data were presented at the Society of Gynecologic Oncology Annual Meeting on Women’s Cancer on 16 March 2024, and were published in Annals of Oncology on 9 June 2024. The label for Jemperli in the US was expanded to all adult patients with primary advanced or recurrent endometrial cancer in August 2024.
