The FDA has accepted and granted Priority Review to GSK's supplemental marketing application for Jemperli (dostarlimab) in combination with chemotherapy for adult patients with mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) primary advanced or recurrent endometrial cancer. This regulatory decision marks a significant step forward in addressing a critical unmet need in endometrial cancer treatment.
If approved, the dostarlimab plus chemotherapy regimen could become the first meaningful frontline treatment advancement in decades for patients with primary advanced or recurrent endometrial cancer. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of September 23.
The application is based on interim analysis results from Part 1 of the Phase 3 RUBY/ENGOT-EN6/GOG3031/NSGO trial. The study met its primary endpoint, demonstrating a statistically significant and clinically meaningful benefit in progression-free survival (PFS) for patients receiving Jemperli in combination with chemotherapy.
The RUBY trial's safety and tolerability analysis indicated that the combination of dostarlimab and carboplatin-paclitaxel was generally well tolerated. Part 1 of the RUBY trial is ongoing to assess the dual-primary endpoint of overall survival (OS) in the intent-to-treat (ITT) population. At the first interim analysis in the ITT population, a clinically meaningful OS trend was observed among patients receiving dostarlimab plus chemotherapy followed by dostarlimab, although statistical significance was not reached, as the analysis was done at 33% maturity.
Dostarlimab also received Breakthrough Therapy designation for this potential new indication.
