The European Commission (EC) has approved GSK’s Jemperli (dostarlimab) combined with chemotherapy that includes carboplatin and paclitaxel for the first-line treatment of primary advanced or recurrent endometrial cancer in adults.
The decision extends the use of the combination in the European Union (EU) for individuals with mismatch repair proficient (MMRp)/microsatellite stable (MSS) tumours.
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Such tumours account for 75% of individuals with endometrial cancer, and present limited treatment alternatives.
The expanded approval is based on the outcomes from Part I of the RUBY Phase III trial – the only study in this setting to demonstrate statistically significant overall survival (OS) benefit across the complete subject population with this cancer type.
A 31% decrease in the mortality risk is observed in the trial versus chemotherapy alone.
GSK oncology, research and development global head and senior vice-president Hesham Abdullah stated: “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.”
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By GlobalDataThe dual-primary endpoints in Part I were investigator-assessed progression-free survival based on the Response Evaluation Criteria in Solid Tumours v1.1 and OS.
At the two-and-a-half-year mark, the probability of survival was 61% for subjects who received the combination, as opposed to 49% for those receiving chemotherapy alone.
A median OS improvement of 16.4 months was observed in the combination group compared to the chemotherapy group alone.
The tolerability and safety profile for Jemperli combined with carboplatin-paclitaxel was consistent with the known safety profiles of the individual agents.
Endometrial cancer originates in the endometrium, which is the inner lining of the uterus.
In early January 2025, the company received the US Food and Drug Administration (FDA) breakthrough therapy designation (BTD) for its B7-H3-targeted antibody-drug conjugate, GSK’227, for treating adults with relapsed or refractory osteosarcoma after a minimum of two lines of previous therapy.
