GSK Announces Positive Phase III Results for Niraparib Combined with Dostarlimab in First-Line Treatment of Advanced Ovarian Cancer
GSK
Pharmaceutical R&D Manufacturer
On December 20, GSK announced,Niraparib Combined with PD-1（Dostarlimab）In first-line treatmentAdvanced Ovarian CancerPhase III Study（FIRST-ENGOT-OV44）ChinaAchieved the primary endpoint of PFS.
Screenshot source: Corporate official website
The results show that,In standard treatment(Carboplatin-Paclitaxel Chemotherapy)And NiraparibMaintenance Therapy(Whether or not combined with bevacizumab)The addition of Dostarlimab in China has statistically significant differences.。
Overall Survival (OS)This key secondary endpoint did not reach statistical significance. Further...The analysis is ongoing, and the data will be shared with health authorities and presented at upcoming scientific conferences.
The safety and tolerability profiles are generally consistent with the known safety profiles of the individual drugs.
FIRST-ENGOT-OV44 is an international, double-blind, randomized Phase III trial, which adds Dostarlimab to the standard treatment.(SOC) Platinum-based chemotherapy and niraparib maintenance treatment(Combined with or without Bevacizumab), as a first-line treatment for stage III or IV non-mucinous epithelial ovarian cancer.
Initially, participants were randomly divided into three groups in a 1:1:2 ratio:
Group 1: SOC chemotherapy, followed by placebo maintenance therapy; Group 2: SOC chemotherapy, followed by niraparib maintenance therapy; Group 3: SOC chemotherapy and Dostarlimab, followed by maintenance treatment with Niraparib and Dostarlimab.
