Clinical Trials

GSK’s Jemperli plus Zejula combination performs well in trial as endometrial cancer treatment

GSK has announced positive results from a planned analysis of the second part of the RUBY/ ENGOT-EN6/GOG3031/NSGO phase 3 trial, which assessed Jemperli (dostarlimab) plus standard-of-care chemotherapy (carboplatin and paclitaxel) followed by Jemperli plus Zejula (niraparib) as a maintenance therapy in adult patients with primary advanced or recurrent endometrial cancer.
The trial met its primary endpoint of progression-free survival (PFS) with a statistically significant and clinically meaningful improvement observed in the overall patient population as well as in a subpopulation of patients with mismatch repair proficient/microsatellite stable (MMRp/MSS) tumours.
The safety profile of dostarlimab plus carboplatin and paclitaxel, as well as dostarlimab plus niraparib, remained generally consistent with the known profiles of the individual drugs.
The drug is already indicated as a monotherapy for the maintenance treatment of adult patients with advanced epithelial highgrade ovarian, fallopian tube or primary peritoneal cancer who are in response following first-line platinum-based chemotherapy, and a monotherapy for the treatment of adult patients with platinumsensitive relapsed high-grade serious epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response to platinum-based chemotherapy.
Full analysis of the trial data, including a secondary endpoint of overall survival (OS), is ongoing, with full results expected to be presented at an upcoming scientific meeting, published in a medical journal and submitted to the relevant regulatory authorities.
Hesham Abdullah, senior vice president and global head Oncology, Research and Development at GSK, commented: “Patients with MMRp/MSS primary advanced or recurrent endometrial cancer have few approved treatment options. 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.”