Dostarlimab shows positive results in phase 3 trial for endometrial cancer

Dostarlimab (Jemperli; GSK plc) has shown positive results in treating endometrial cancer in the first part of the RUBY phase 3 trial, GSK plc has announced.

The trial evaluated the safety and efficacy of dostarlimab alongside standard chemotherapy for treating endometrial cancer compared to chemotherapy and a placebo. Investigator-assessed progression-free survival was the primary endpoint of the study, which was successfully met. Significant and clinically meaningful benefits were observed in the study population.

Benefits were also observed in the prespecified mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) and the mismatch repair proficient (MMRp)/microsatellite stable (MSS) subgroups.

Overall survival data was immature during the analysis, but the overall population saw a promising trend throughout the trial. This trend was also seen in the dMMR/MSI-H and MMRp/MSS subgroups.

The safety and tolerability of dostarlimab were constant with similar procedures in the RUBY trial. Adverse events included fatigue, nausea, peripheral neuropathy, alopecia, arthralgia, constipation, diarrhea, and anemia.

Endometrial cancer infects the endometrium, and it is the most common gynecologic cancer in the United States and the second most common worldwide. Advanced disease is seen in 15% to 20% of women during diagnosis of endometrial cancer.

Dostarlimab binds the programmed death receptor-1 (PD-1) receptor, keeping it from connecting with PD-1 ligands. It is being studied for use as a monotherapy and in combination regimens for treating recurrent or primary advanced endometrial cancer and nonmucinous epithelial ovarian cancer in women, along with advanced solid tumors or metastatic cancers in patients.

GSK plc plans to submit trial results within the first half of 2023 and to publish the full results in a medical journal. The results will also be presented at a future scientific meeting.

Reference

Jemperli (dostarlimab) RUBY phase III trial met its primary endpoint in a planned interim analysis in patients with primary advanced or recurrent endometrial cancer. GSK. December 2, 2022. Accessed December 2, 2022. https://www.gsk.com/en-gb/media/press-releases/jemperli-dostarlimab-ruby-phase-iii-trial-met-its-primary-endpoint-in-a-planned-interim-analysis-in-patients-with-primary-advanced-or-recurrent-endometrial-cancer/