By Fineline Cube 
UK-based GSK plc (NYSE: GSK, LON: GSK) has announced receiving approval from the European Commission for a new indication for its PD-1-blocking antibody Jemperli (dostarlimab). The drug is now approved for use in combination with chemotherapy (carboplatin and paclitaxel) as a first-line treatment for adult patients with primary advanced or recurrent endometrial cancer who are candidates for systemic therapy. This approval expands Jemperli’s indication in the European Union (EU) to include patients with mismatch repair proficient (MMR-p)/microsatellite stable (MSS) tumors, which account for approximately 75% of endometrial cancer cases and have limited treatment options.
Discovery and Licensing
Jemperli was discovered by AnaptysBio, Inc. and licensed to TESARO, Inc. (later acquired by GSK) in March 2014. Under the agreement, GSK assumed responsibility for the ongoing research, development, commercialization, and manufacturing of Jemperli and cobolimab (GSK4069889), a TIM-3 antagonist.
Regulatory Decision and Clinical Data
The European Commission’s approval was supported by results from the first part of the Phase III RUBY study. Compared to chemotherapy alone, the Jemperli/chemo combination reduced the risk of patient mortality by 31%, extended median overall survival (OS) by 16.4 months (44.6 months vs. 28.2 months), and demonstrated good safety and tolerability. These findings highlight the potential of Jemperli to improve outcomes for patients with endometrial cancer.-Fineline Info & Tech