GSK plc revealed that the US Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) for Jemperli (dostarlimab) in combination with standard-of-care chemotherapy (carboplatin and paclitaxel) for expanding treatment to all adult patients with primary advanced or recurrent endometrial cancer, including those with mismatch repair proficient (MMRp)/microsatellite stable (MSS) tumors.
Jemperli, currently approved by the FDA in combination with carboplatin and paclitaxel followed by single-agent Jemperli for treating adult patients with primary advanced or recurrent endometrial cancer that is either mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H), has been granted Priority Review for this application with an action date set for August 23, 2024.
This decision is grounded on the positive results from Part 1 of the RUBY phase III trial, which met its primary endpoints of investigator-assessed progression-free survival (PFS) and overall survival (OS), demonstrating a statistically significant and clinically meaningful benefit in the overall patient population treated with dostarlimab plus carboplatin-paclitaxel compared to chemotherapy alone. Notably, RUBY Part 1 is the sole clinical trial showcasing a statistically significant survival benefit in the overall patient cohort.
Endometrial cancer, prevalent in the inner lining of the uterus (endometrium), is the most common gynecologic cancer in developed nations, with an anticipated rise in incidence rates. Approximately 15-20% of patients with endometrial cancer are diagnosed with advanced disease at diagnosis, with a majority having MMRp/MSS tumors.
RUBY, a two-part global phase III trial, evaluates dostarlimab plus carboplatin-paclitaxel followed by dostarlimab versus carboplatin-paclitaxel plus placebo followed by placebo. Part 1’s dual-primary endpoints are investigator-assessed PFS and OS. Pre-specified analyses include subpopulations such as dMMR/MSI-H and MMRp/MSS.
Jemperli, a programmed death receptor-1 (PD-1)-blocking antibody, holds promise in transforming treatment paradigms for endometrial cancer, and GSK remains committed to advancing oncology treatments, particularly in gynecologic cancers, through breakthroughs in immuno-oncology and targeted therapies.
