GSK's Immuno-Oncology Combination Therapy Meets Primary Endpoint of Progression-Free Survival in Phase III RUBY Trial for Advanced or Recurrent Endometrial Cancer

▎WuXi

Edited by Kant Content Team

GSK announced today the pre-specified analysis results from the RUBY Phase 3 clinical trial. The second part of the trial examined the efficacy and safety of the PD-1 inhibitor Jemperli (dostarlimab) combined with standard chemotherapy (carboplatin and paclitaxel), followed by Jemperli plus the PARP inhibitor Zejula (niraparib) as maintenance therapy, in adult patients with primary advanced or recurrent endometrial cancer. The analysis showed,Patients using Jemperli combination therapy showed significant improvement in progression-free survival (PFS).The full data of the trial will be disclosed at future medical conferences.

The RUBY trial is a randomized, double-blind, multicenter Phase 3 trial,Part 2 of the trial evaluation showed that Jemperli in combination therapy compared with placebo + chemotherapy, followed by placebo, achieved the primary endpoint, demonstrating statistically significant and clinically meaningful benefits in both the overall patient population and the subgroup of patients with mismatch repair proficient/microsatellite stable (MMRp/MSS) tumors.Analysis of other trial data is ongoing, with data for the key secondary endpoint of overall survival (OS) not yet mature; follow-up will continue.

The analysis showed that the safety profile of Jemperli combination therapy was generally consistent with the known safety profiles of the individual drugs.

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 in July this year.Approved

In 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 have DNA mismatch repair deficiency (dMMR) or high microsatellite instability (MSI-H) by an FDA-approved test. Zejula is an oral, once-daily PARP inhibitor acquired by GSK through the acquisition of TESARO. PARP inhibitors are targeted therapies that kill cancer cells by inhibiting PARP-mediated DNA damage repair response (DDR). Based on the principle of "synthetic lethality," they can kill cancer cells without affecting healthy cells.

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References:

[1] Jemperli (dostarlimab) plus Zejula (niraparib)combination significantly improved progression-free survival in primaryadvanced or recurrent endometrial cancer in RUBY Part 2 Phase III trial. RetrievedDecember 19, 2023 from https://www.gsk.com/en-gb/media/press-releases/jemperli-plus-zejula-combination-significantly-improved-progression-free-survival-in-endometrial-cancer-phase-iii-trial/

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