GSK Announces Positive Phase 3 RUBY Trial Results: Jemperli Plus Chemotherapy Significantly Improves Overall Survival in Advanced or Recurrent Endometrial Cancer

▎WuXi

Edited by Kant Content Team

GSK Announces Results from the Pre-specified Analysis of Part 1 of the Phase 3 RUBY Clinical TrialThe trial met the primary endpoint of overall survival (OS), demonstrating that the drug provides a statistically significant and clinically meaningful benefit in the overall patient population.According to the press release,Jemperli + chemotherapy is the first immuno-oncology combination treatment regimen to demonstrate OS benefits in this patient population.

Endometrial cancer is one of the most common gynecological cancers. Approximately 15-20% of patients with endometrial cancer are diagnosed at an advanced stage. Among all cases of endometrial cancer, about 20-29% are mismatch repair-deficient (dMMR) or high microsatellite instability (MSI-H).

Jemperli is an antibody that binds to the PD-1 receptor and blocks its interaction with the ligands PD-L1 and PD-L2.In the treatment of endometrial cancer, Jemperli has been approved by the U.S. FDA as a monotherapy for dMMR advanced or recurrent endometrial cancer after prior treatment with platinum-containing therapy. Additionally, this treatment was approved earlier this year.Approved in JulyIn combination with carboplatin and paclitaxel, followed by Jemperli as a single agent for the treatment of adult patients with primary advanced or recurrent endometrial cancer determined to be dMMR/MSI-H by an FDA-approved test.

The analysis shows,Clinically meaningful OS benefits were observed in both predefined subgroups, namely, the dMMR/MSI-H and mismatch repair proficient (MMRp)/microsatellite stable (MSS) patient subgroups.OS is one of the two primary endpoints of Part 1 of the RUBY trial. Previously, the trial met its other primary endpoint, progression-free survival (PFS), demonstrating a reduction in the risk of disease progression or death by 72% in the dMMR/MSI-H population (HR: 0.28, 95% CI: 0.16-0.50) and by 36% in the overall patient population (HR: 0.64, 95% CI: 0.51-0.80).

The safety and tolerability profile of Jemperli plus carboplatin and paclitaxel is generally consistent with the known safety profiles of the individual drugs.