GSK said that its cancer drug Jemperli (dostarlimab) in combination with chemotherapy has met the primary endpoint of overall survival (OS) in Part 1 of the RUBY/ENGOT-EN6/GOG3031/NSGO Phase 3 trial of certain endometrial cancer patients.
Jemperli is a programmed death receptor-1 (PD-1)-blocking antibody. It is designed to bind to the PD-1 receptor and stop its interaction with the PD-1 ligands PD-L1 and PD-L2.
The late-stage trial assessed the Jemperli plus standard-of-care chemotherapy (carboplatin and paclitaxel). It was followed by dostarlimab as a single agent against placebo plus chemotherapy followed by a placebo in adult patients with primary advanced or recurrent endometrial cancer.
According to the British drug maker, the trial showed a statistically significant and clinically meaningful benefit in the overall patient population.
In addition, a clinically meaningful OS benefit was noted in prespecified subpopulations in the trial.
The safety and tolerability profile of dostarlimab combined with paclitaxel and carboplatin was generally consistent with the known safety profiles of each drug alone.
GSK Oncology global head and SVP Hesham Abdullah said: “With today’s headline results from Part 1 of the phase 3 RUBY trial, dostarlimab plus chemotherapy has become the only immuno-therapy combination to show a survival benefit in this broader patient population in this treatment setting.
“We look forward to sharing detailed results of this analysis with regulatory authorities and the larger scientific community.”
RUBY is a two-part global, randomised, double-blind, multi-centre phase III trial.
The dual-primary endpoints in Part 1 are defined as the investigator-assessed progression-free survival (PFS) based on the Response Evaluation Criteria in Solid Tumours v1.1 and OS.
In the US and the UK, Jemperli is approved for the combination of chemotherapy and targeted subtypes of advanced or recurrent endometrial cancer treatment.
The recent findings can open the door for approval in a far larger patient population, Reuters reported.
The company, which has been working to revive its oncology division in recent years, anticipates approval from Europe’s regulatory body by the end of 2023.
