- The FDA accepted the supplemental marketing application for GSK Plc's GSK Jemperli (dostarlimab) in combination with chemotherapy for the treatment of adult patients with mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) primary advanced or recurrent endometrial cancer.
- The company says if approved in this patient population, dostarlimab plus chemotherapy could represent the first meaningful frontline treatment advancement in decades for patients with primary advanced or recurrent endometrial cancer.
- The FDA granted Priority Review and assigned a Prescription Drug User Fee Act action date of 23 September.
- Dostarlimab also was recently granted Breakthrough Therapy designation for this potential new indication.
- The application is based on the prespecified interim analysis results from Part 1 of the RUBY/ENGOT-EN6/GOG3031/NSGO phase 3 trial. The trial met its primary endpoint of progression-free survival (PFS), demonstrating a statistically significant and clinically meaningful benefit in patients.
- The safety and tolerability analysis from RUBY showed a safety profile for dostarlimab and carboplatin-paclitaxel that was generally well tolerated.
- Part 1 of the RUBY trial continues 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. The OS analysis was done at 33% maturity, and statistical significance was not reached.
- Price Action: GSK shares are up 0.79% at $34.55 on the last check Tuesday.
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