GSK has announced promising results from the Phase III RUBY/ENGOT-EN6/GOG3031/NSGO clinical trial of the programmed death receptor-1 (PD-1)-hindering antibody Jemperli (dostarlimab) in adults with advanced or recurrent endometrial cancer.
The global, double-blind, randomised, multicentre trial consisted of two parts.
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Part I portion of the study has been designed to compare the effects of dostarlimab plus carboplatin-paclitaxel followed by dostarlimab against chemotherapy plus placebo, followed by placebo.
Progression-free survival (PFS) and overall survival (OS) were the dual-primary endpoints of this segment.
Part II of the trial investigated the addition of niraparib to the dostarlimab regimen.
The primary endpoint for this section was investigator-assessed PFS in the overall population, with subsequent analysis of PFS in the mismatch repair proficient/microsatellite stable (MMRp/MSS) population.
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By GlobalDataOS in the overall subjects is a key secondary endpoint of this portion.
The trial also monitored additional secondary endpoints, including PFS, PFS2, duration of response, overall response rate, disease control rate, subject-reported outcomes, and safety and tolerability.
Results revealed a statistically significant and clinically meaningful improvement in OS for Part I and PFS for Part II, meeting the primary endpoints for both parts of the study.
The safety profiles of the drug combinations used in the trial were consistent with the known profiles of the individual medicines.
Prior data had already demonstrated a significant PFS improvement with Jemperli plus chemotherapy compared to chemotherapy alone in frontline dMMR/MSI-H primary advanced or recurrent endometrial cancer, leading to regulatory approvals in the US, European Union, and other regions.
GSK R&D, Oncology global head, senior vice-president Hesham Abdullah said: “The positive data further show how dostarlimab-based regimens could benefit a broader set of patients with endometrial cancer.
“The results we’ve seen to date comprise the growing body of evidence supporting the role of dostarlimab as the backbone of our immuno-oncology development programme.
“Our goal is to continue to identify ways to use dostarlimab alone and in combination with other therapies to help improve outcomes for patients with limited treatment options.”
Earlier this month, the company reported positive interim headline data from the Phase III DREAMM-8 trial of Blenrep (belantamab mafodotin) to treat relapsed or refractory multiple myeloma.
