
Pharmaceutical R&D Manufacturer
GSK announced today the primary results of the FIRST-ENGOT-OV44X Phase 3 clinical trial, which evaluated the efficacy and safety of the PARP inhibitor Zejula (niraparib) and its PD-1 inhibitor Jemperli (dostarlimab) for the first-line treatment of advanced ovarian cancer. The analysis showed,The trial met the primary endpoint of progression-free survival (PFS).The results showed that adding dostarlimab to the standard care regimen of carboplatin-paclitaxel chemotherapy and niraparib maintenance therapy, with or without bevacizumab, demonstrated a statistically significant difference.

FIRST-ENGOT-OV44is an international, double-blind, randomized3Phase Trial.This trial aims to evaluate the standard of care (SOC)Platinum-based chemotherapy andniraparibOn the basis of maintenance treatment, regardless of whether it is combined with Bevacizumab, adddostarlimabAsIIIPeriod orIVEfficacy and Safety of First-Line Treatment for Non-Mucinous Epithelial Ovarian Cancer.
Analysis shows that the trial met the primary endpoint PFS, but the key secondary endpoint overall survival (OS) did not reach statistical significance. Further analysis is ongoing, and relevant data will be submitted to health regulatory authorities and disclosed at an upcoming scientific conference. The safety and tolerability results of the trial are generally consistent with the known safety profiles of each individual drug.

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 for use after prior platinum-containing therapy.Deficient Mismatch Repair (dMMR)Monotherapy for advanced or recurrent endometrial cancer. In addition, this therapy was approved in July of last year.ApprovedIn 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 that is dMMR or high microsatellite instability (MSI-H), as determined by an FDA-approved test. This month, the FDAGrantJemperliBreakthrough Therapy Designation (BTD),For the treatment of dMMR/MSI-H rectal cancer.
Zejula is an oral, once-daily PARP inhibitor that GSK acquired through the purchase of TESARO.PARP inhibitors are a targeted therapy that kills cancer cells by inhibiting PARP-mediated DNA damage repair (DDR). Based on the principle of "synthetic lethality," they can kill cancer cells while minimizing the impact on healthy cells.



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