Sharecast - The FTSE 100 pharmaceuticals giant said part two of the RUBY phase three trial focussed on investigating the combination of Jemperli, or dostarlimab with standard-of-care chemotherapy followed by dostarlimab plus Zejula, or niraparib, as maintenance therapy in adult patients with primary advanced or recurrent endometrial cancer.
It said the primary endpoint of progression-free survival (PFS) was successfully met in the trial.
Notably, a statistically significant and clinically meaningful benefit was observed in both the overall patient population and in a subpopulation of patients with mismatch repair proficient/microsatellite stable (MMRp/MSS) tumours.
While the analysis of the full trial data was still ongoing, including the key secondary endpoint of overall survival (OS), GSK (LON:GSK) noted that overall survival data was still considered immature and would continue to be monitored.
The safety profile of the combination of dostarlimab plus carboplatin and paclitaxel, followed by dostarlimab plus niraparib, was generally consistent with the known safety profiles of the individual agents, which is a positive indicator for patient well-being.
Complete results from this analysis would be presented at an upcoming scientific meeting, published in a medical journal, and shared with regulatory authorities.
“Patients with MMRp/MSS primary advanced or recurrent endometrial cancer have few approved treatment options,” said GSK’s senior vice president and global head of oncology research and development Hesham Abdullah.
“Today's positive topline results reinforce our approach of building combination therapies with dostarlimab as the backbone in an effort to improve patient outcomes and options.”
At 0806 GMT, shares in GSK were up 0.44% at 1,425.4p.
Reporting by Josh White for Sharecast.com.
