GSK: Phase III Trial Of Jemperli + Chemotherapy Meets OS Endpoint In Recurrent Endometrial Cancer

(RTTNews) - GSK plc (GSK,GSK.L) announced positive headline results from a planned analysis of Part 1 of phase III trial investigating 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 in adult patients with primary advanced or recurrent endometrial cancer.

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

The company noted that a clinically meaningful overall survival 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.

Previously, the trial met its other primary endpoint of progression-free survival or PFS, 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.

Currently, Jemperli has regulatory approvals in a certain subset of patients with endometrial cancer based on the previously reported positive 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 the treatment of adult patients with 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).

Jemperli was also approved in the United Kingdom in October 2023 in combination with platinum-containing chemotherapy for the treatment of adult patients with dMMR/MSI-H primary advanced or recurrent endometrial cancer and who are candidates for systemic therapy.

The application remains under review in the European Union (EU), Australia, Canada, Switzerland and Singapore.

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