GSK has secured approval from the US Food and Drug Administration (FDA) for Jemperli (dostarlimab) plus chemotherapy to treat adults with primary advanced or recurrent endometrial cancer (EC).
The PD-1-blocking antibody has been approved in combination with carboplatin and paclitaxel (chemotherapy), followed by Jemperli as a single agent.
The approval extends the previous indication for Jemperli in combination with chemotherapy to now include patients with mismatch repair proficient (MMRp) or microsatellite stable (MSS) tumours.
Jemperli’s supplemental biologics licence application (sBLA) for this expanded use was granted priority review by the FDA and approved before the Prescription Drug User Fee Act (PDUFA) action date.
In July 2023, the regulatory agency approved the combination of PD-1-blocking antibody and chemotherapy, along with dostarlimab monotherapy, for use in adult patients with EC that is mismatch repair deficient (dMMR) or microsatellite instability high (MSI-H).
GSK R&D oncology global head and senior vice president Hesham Abdullah said: “Jemperli plus chemotherapy is the first and only immuno-oncology regimen to show significant and meaningful improvement in overall survival for adult patients with primary advanced or recurrent endometrial cancer regardless of biomarker status.
“We are thrilled this option is now available for more patients in the US, including the 70-75% with MMRp/MSS tumours where treatment options have been limited.”
The latest approval is based on results from the dual primary endpoints of progression-free survival (PFS) and overall survival (OS) as assessed by investigators in Part 1 of the RUBY Phase 3 trial.
RUBY is a global, randomised, double-blind, multicentre late-stage trial with two parts, designed to evaluate treatments in patients with primary advanced or recurrent EC.
Part 1 showed a 31% reduction in the risk of death compared to chemotherapy alone.
At the 2.5-year mark, 61% of patients in the Jemperli plus chemotherapy arm were alive, compared to 49% in the chemotherapy-only group.
Additionally, the median OS was improved by 16.4 months with Jemperli plus chemotherapy versus chemotherapy alone.
Furthermore, the safety profile of PD-1-blocking antibody combined with carboplatin-paclitaxel was generally consistent with the known profiles of the individual agents.
RUBY Part 2 is evaluating the dostarlimab combo followed by dostarlimab plus Zejula (niraparib) versus placebo plus carboplatin-paclitaxel followed by placebo.
In December 2023, the British drugmaker announced that the Jemperli with Zejula combination achieved the primary endpoint in the Phase 3 EC trial.
