GSK has reported that part two of the Phase III RUBY/ENGOT-EN6/GOG3031/NSGO clinical trial of Jemperli (dostarlimab) plus chemotherapy in adults with primary advanced or recurrent endometrial cancer met the primary endpoint of progression-free survival (PFS).
A programmed death receptor-1 (PD-1)-hindering antibody, Jemperli attaches to the PD-1 receptor and hinders its contact with the PD-L1 and PD-L2, two PD-1 ligands.
The global, double-blind, randomised, multicentre has two parts.
Part one is assessing dostarlimab plus standard-of-care chemotherapy comprising carboplatin and paclitaxel and subsequent dosing with dostarlimab compared to carboplatin-paclitaxel plus placebo followed by placebo.
Part two is designed to assess dostarlimab plus chemotherapy after dostarlimab plus Zejula (niraparib) as maintenance therapy against placebo plus carboplatin-paclitaxel and then placebo.
The primary endpoint of part two portion is investigator-evaluated PFS in the overall subjects and PFS in the mismatch repair proficient/microsatellite stable (MMRp/MSS) patients.
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Overall survival (OS) in the complete patient population is the trial’s crucial secondary endpoint.
According to the positive part two analysis data from the trial, the combination of Jemperli (dostarlimab) plus chemotherapy and Zejula against placebo plus chemotherapy followed by placebo demonstrated to offer a meaningful PFS benefit in the overall and MMRp/MSS patient populations.
The company is evaluating the complete trial data, including the OS, which is currently immature.
In the trial, the safety profile of dostarlimab plus chemotherapy, after dostarlimab plus niraparib, was found to be in line with already reported data of the individual agents.
GSK Oncology, R&D global head and senior vice-president Hesham Abdullah said: “Patients with MMRp/MSS primary advanced or recurrent endometrial cancer have few approved treatment options.
“The positive topline results reinforce our approach of building combination therapies with dostarlimab as the backbone in an effort to improve patient outcomes and options.”
Last month, the company reported positive headline data from the Phase III DREAMM-7 head-to-head trial of Blenrep as a second-line therapy for relapsed or refractory (R/R) multiple myeloma.