Biopharmaceutical company GSK (LSE: GSK) (NYSE: GSK) announced on Monday that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the expansion of Jemperli (dostarlimab) approval. This would allow its use in combination with chemotherapy for all adult patients with primary advanced or recurrent endometrial cancer, including those with mismatch repair proficient (MMRp)/microsatellite stable (MSS) tumours, which account for 70-75% of endometrial cancer cases.

The positive opinion is based on the results from the RUBY phase III trial, which showed statistically significant improvements in progression-free survival (PFS) and overall survival (OS) for patients treated with dostarlimab plus carboplatin-paclitaxel compared to chemotherapy alone. This makes it the first immuno-oncology regimen to demonstrate a significant OS benefit for this patient group.

A final approval decision by the European Commission is expected in Q1 2025. The US label for Jemperli was expanded in August 2024 to include all adult patients with advanced or recurrent endometrial cancer.

Jemperli is a PD-1-blocking antibody used in various cancers, and its ongoing clinical trials aim to explore its potential in multiple tumour types.