GSK gets European Commission marketing authorisation for Jemperli, chemotherapy combo for endometrial cancer

Dr Mansoor Raza Mirza, Chief Oncologist, Copenhagen University Hospital, Denmark and RUBY principal investigator, said, “The European Commission approval is welcomed news as I believe it will define a new standard of care for certain patients with advanced or recurrent endometrial cancer in the EU. The results from the RUBY trial, which led to this approval, underscore the practice-changing potential of dostarlimab for these patients.”

The EC authorisation of Jemperli is based on interim analysis results from the dMMR/MSI-H population of Part 1 of the RUBY/ENGOT-EN6/GOG3031/NSGO phase III trial, which reflected a robust median duration of follow-up of ≥ 25 months. The trial met its primary endpoint of investigator-assessed progression-free survival (PFS), demonstrating a statistically significant and clinically meaningful benefit in patients treated with Jemperli plus carboplatin and paclitaxel in the dMMR/MSI-H population. In this population, a 72% reduction in the risk of disease progression or death was observed relative to chemotherapy alone (HR: 0.28 [95% CI: 0.16-0.50]).

In a prespecified, exploratory analysis of overall survival (OS) in the dMMR/MSI-H population, the addition of Jemperli to chemotherapy resulted in a 70% reduction in the risk of death relative to chemotherapy alone (HR: 0.30 [95% CI: 0.13-0.70]).

Results were presented at the European Society for Medical Oncology (ESMO) Virtual Plenary and Society of Gynecologic Oncology (SGO) Annual Meeting on 27 March 2023, and simultaneously published in The New England Journal of Medicine.

PFS is one of two primary endpoints in the RUBY Part 1 trial. In a subsequent planned analysis, the RUBY trial met its other primary endpoint of OS, demonstrating a statistically significant and clinically meaningful benefit in the overall patient population.

The safety and tolerability profile for Jemperli plus carboplatin and paclitaxel was generally consistent with the known safety profiles of the individual agents. 

Read also: GSK declares positive results from phase III trial for Blenrep in relapsed/ refractory multiple myeloma