Jemperli plus Zejula combo significantly improved progression-free survival in primary advanced or recurrent endometrial cancer: GSK
London: GSK plc has announced positive headline results from a planned analysis of Part 2 of the RUBY/ENGOT-EN6/GOG3031/NSGO phase III trial investigating Jemperli (dostarlimab) plus standard-of-care chemotherapy (carboplatin and paclitaxel), followed by dostarlimab plus Zejula (niraparib) as maintenance therapy, in adult patients with primary advanced or recurrent endometrial cancer.
The trial, which evaluated this combination against placebo plus chemotherapy followed by placebo, met its primary endpoint of progression-free survival (PFS), with a statistically significant and clinically meaningful benefit observed in both the overall patient population and in a subpopulation of patients with mismatch repair proficient/microsatellite stable (MMRp/MSS) tumours.
Endometrial cancer is found in the inner lining of the uterus, known as the endometrium. Endometrial cancer is the most common gynaecologic cancer in developed countries, with approximately 417,000 new cases reported each year worldwide, and incidence rates are expected to rise by almost 40% between 2020 and 2040. Approximately 15-20% of patients with endometrial cancer will be diagnosed with advanced disease at the time of diagnosis.
Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D, GSK, said, “Patients with MMRp/MSS primary advanced or recurrent endometrial cancer have few approved treatment options. The positive topline results reinforce our approach of building combination therapies with dostarlimab as the backbone in an effort to improve patient outcomes and options.”
Analysis of the full trial data, including the key secondary endpoint of overall survival (OS), is ongoing. OS data is immature and will continue to be followed.
The safety profile of dostarlimab plus carboplatin and paclitaxel, followed by dostarlimab plus niraparib, was generally consistent with the known safety profiles of the individual agents.
Full results from this analysis will be presented at an upcoming scientific meeting, published in a medical journal, and shared with regulatory authorities.
