UK-based GSK plc (NYSE: GSK) has announced a positive readout from the Phase III FIRST-ENGOT-OV44 trial for Jemperli (dostarlimab), a programmed death-1 (PD-1) inhibitor, when combined with Zejula (niraparib) for the first-line treatment of advanced ovarian cancer. The trial evaluated the addition of Jemperli to the standard of care carboplatin-paclitaxel chemotherapy and niraparib maintenance, with or without bevacizumab, and demonstrated a significant improvement in progression-free survival (PFS), meeting the primary endpoint.
Progression-Free Survival (PFS) and Overall Survival (OS) Outcomes
While the key secondary endpoint of overall survival (OS) did not achieve statistical significance, the safety and tolerability of the combination were found to be generally consistent with the known safety profiles of the individual agents. This suggests that the combination therapy may offer a viable treatment option for patients with advanced ovarian cancer without compromising safety.
Jemperli’s Background and Development
Jemperli was discovered by AnaptysBio, Inc. and was licensed to TESARO, Inc. in March 2014, which was later acquired by GSK. This deal made GSK responsible for the ongoing research, development, commercialization, and manufacturing of Jemperli, as well as cobolimab (GSK4069889), a TIM-3 antagonist. Jemperli has been approved in the US for the treatment of primary advanced or recurrent endometrial cancer, either as a standalone therapy or in combination with chemotherapy.-Fineline Info & Tech
