GSK’s Jemperli (dostarlimab) has been granted expanded approval by the European Commission (EC) to treat a broader range of endometrial cancer patients.
The PD-1-blocking antibody has been authorised for use in combination with carboplatin and paclitaxel chemotherapy for the first-line treatment of adults with primary advanced or recurrent endometrial cancer who are candidates for systemic therapy.
This covers patients with mismatch repair proficient (MMRp)/microsatellite stable (MSS) tumours, who represent up to 75% of those diagnosed with the disease but were not previously covered by the drug’s EU label.
Endometrial cancer is the most common gynaecological cancer in developed countries, with an estimated 1.6 million people living with active disease at any stage and 417,000 new cases reported globally every year.
GSK’s Jemperli is designed to help the body’s immune system find and attack cancer cells, and is already approved in the EU to treat certain adults with mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) endometrial cancer.
The EC’s latest decision on the drug follows a recent recommendation from the European Medicines Agency’s human medicines committee and was based on positive results from part one of the late-stage RUBY trial, in which Jemperli plus chemotherapy demonstrated a 31% reduction in risk of death compared to chemotherapy alone.
After 2.5 years, patients being treated with Jemperli plus chemotherapy had a 61% chance of survival, compared to 49% for those randomised to receive chemotherapy alone.
A 16.4-month improvement in median overall survival was also observed for the Jemperli combination versus chemotherapy alone, and the safety profile for Jemperli plus chemotherapy was generally consistent with the known safety profiles of the individual agents.
Commenting on the new authorisation, Hesham Abdullah, senior vice president, global head oncology, research and development, GSK, said: “For the first time, all patients with primary advanced or recurrent endometrial cancer in the EU have an approved immuno-oncology-based treatment that has shown a statistically significant and clinically meaningful overall survival benefit.”
The announcement comes just one week after GSK revealed that it will be expanding its gastrointestinal cancer pipeline by acquiring IDRx in a deal worth up to $1.15bn.