Hope for Endometrial Cancer - GSK Drug Proves Effective in Increasing Survival Rates

GSK plc GSK released headline results from a planned analysis of Part 1 of the RUBY phase 3 trial of Jemperli (dostarlimab) plus standard-of-care chemotherapy (carboplatin and paclitaxel), followed by dostarlimab as a single agent, compared to placebo plus chemotherapy followed by placebo for primary advanced or recurrent endometrial cancer. 

The trial met its primary endpoint of overall survival (OS), demonstrating a statistically significant and clinically meaningful benefit in the overall patient population.

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A clinically meaningful OS benefit was observed in both prespecified subpopulations in the trial: mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) and mismatch repair proficient (MMRp)/microsatellite stable (MSS) patient subgroups. 

OS is one of two primary endpoints in the RUBY Part 1 trial. 

Previously, the trial met its other primary endpoint of progression-free survival, demonstrating a 72% and 36% reduction in the risk of disease progression or death observed in the dMMR/MSI-H population and overall patient population, respectively.

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

Currently, Jemperli is approved in a certain subset of patients with endometrial cancer based on the previously reported results for the primary endpoint of progression-free survival in Part 1 of the RUBY trial. 

In July 2023, Jemperli received FDA approval in combination with carboplatin and paclitaxel, followed by Jemperli as a single agent for primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR), as determined by an FDA-approved test, or microsatellite instability-high (MSI-H). 

Price Action: GSK shares are up 2.01% at $35.26 on the last check Monday.