Today, GlaxoSmithKline PLC (GSK) announced that its PD-1 inhibitor Jemperli (dostarlimab) and PARP inhibitor Zejula (niraparib) The combination therapy achieved the primary endpoint – progression-free survival (PFS) – in a Phase III clinical trial targeting first-line treatment for patients with advanced ovarian cancer.Although the combination therapy achieved a statistically significant improvement in prolonging progression-free survival, it did not meet the secondary endpoint of overall survival (OS).This international, double-blind, randomized Phase III trial, named FIRST-ENGOT-OV44, is led by GINECO (French Cooperative Group for Gynecologic Oncology).This trial enrolled a total of 1,138 patients with stage III/IV non-mucinous epithelial ovarian cancer.Participants were randomly assigned to three groups (1:1:2),Group 1: Maintenance treatment with placebo after standard chemotherapy;Group 2: Maintenance treatment with niraparib after standard chemotherapy;Group 3: Standard treatment of chemotherapy combined with dostarlimab, followed by maintenance therapy with niraparib and dostarlimab. Bevacizumab can be added at the discretion of the investigator in all groups. The primary endpoint is investigator-assessed PFS in Groups 2 and 3. Secondary endpoints include OS, PFS2, and time to first and second subsequent treatments.The trial met the primary endpoint of PFS, indicating that the addition of dostarlimab to standard-of-care chemotherapy and niraparib maintenance therapy, with or without bevacizumab, resulted in a statistically significant improvement in PFS compared to the group receiving chemotherapy plus niraparib alone.。The key secondary endpoint OS did not reach statistical significance.The overall safety and tolerability profile is consistent with the known safety profiles of each individual drug.GSK Plans to Submit Detailed Data to Regulatory Authorities and Release It at the Upcoming Medical Conference.Jemperli (Dostarlimab) is a programmed death receptor-1 (PD-1) blocking antibody and a cornerstone of GSK's ongoing immuno-oncology-based R&D program.GSK acquired Jemperli and Zejula in 2019 for $5.1 billion through the acquisition of Tesaro.Jemperli was initially discovered by AnaptysBio and licensed to TESARO under a collaboration and exclusive license agreement signed in March 2014.。
Zejula (Niraparib) is an oral, once-daily PARP inhibitor.Zejula was initially developed by Tesaro and is one of the company's key marketed products.。
Reference: GSK Official Website
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