GSK plc (LSE/NYSE: GSK) today announced headline results from the FIRST-ENGOT-OV44 phase III trial evaluating Zejula (niraparib) and Jemperli (dostarlimab) in first line advanced ovarian cancer. The trial met its primary endpoint of PFS demonstrating a statistically significant difference with the addition of dostarlimab to both standard of care carboplatin-paclitaxel chemotherapy and niraparib maintenance, with or without bevacizumab.
· Addition of Jemperli (dostarlimab) to both platinum-based chemotherapy and Zejula (niraparib) maintenance, with or without bevacizumab, demonstrated a statistically significant effect on progression free survival (PFS) versus active comparator arm
Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D, GSK, said: “As part of our focus in gynaecological cancers, we continue to evaluate the potential of this combination and look forward to sharing full results from the trial.”
The key secondary endpoint of overall survival did not meet statistical significance. Further analyses are ongoing and data will be shared with health authorities and presented at an upcoming scientific meeting.
The safety and tolerability profile was generally consistent with the known safety profiles of the individual agents.
