EC Approves GSK's Jemperli Combo for Wider Endometrial Cancer Use

GSK has achieved a significant milestone with the European Commission's expanded approval of Jemperli (dostarlimab) for a wider group of endometrial cancer patients. This PD-1-blocking antibody is now authorized for use alongside carboplatin and paclitaxel chemotherapy as a first-line treatment for adults with either primary advanced or recurrent endometrial cancer who are eligible for systemic therapy. A notable aspect of this approval is that it includes individuals with mismatch repair proficient (MMRp) or microsatellite stable (MSS) tumors, who constitute up to 75% of diagnosed cases. Previously, these patients were not encompassed by the drug's EU authorization.

Endometrial cancer stands as the most prevalent gynecological cancer in developed nations, affecting an estimated 1.6 million individuals with active disease at various stages, and approximately 417,000 new cases are reported globally each year. Jemperli aims to enhance the immune system's ability to detect and attack cancer cells. It already has EU approval for treating certain adults with mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) endometrial cancer.

The European Commission's latest decision follows a positive recommendation from the European Medicines Agency's human medicines committee. This endorsement was supported by promising results from part one of the late-stage RUBY trial. In this study, Jemperli combined with chemotherapy showed a 31% reduction in the risk of death compared to chemotherapy alone. After two and a half years, patients receiving the Jemperli and chemotherapy combination had a 61% survival probability, in contrast to 49% for those treated with chemotherapy alone. Additionally, there was a 16.4-month increase in median overall survival for the Jemperli regimen compared to chemotherapy alone. The safety profile of the Jemperli combination was largely consistent with the known profiles of the individual drugs.

Hesham Abdullah, GSK's senior vice president and global head of oncology research and development, expressed his enthusiasm about the new authorization. He highlighted that, for the first time, all patients in the EU with primary advanced or recurrent endometrial cancer have access to an approved immuno-oncology-based therapy, demonstrating a statistically significant and clinically meaningful survival advantage.

This announcement comes on the heels of GSK's recent strategic move to enhance its gastrointestinal cancer pipeline by acquiring IDRx in a deal potentially worth up to $1.15 billion. This expansion underscores GSK's commitment to advancing cancer treatment options and addressing the needs of a broader patient population.

The approval of Jemperli for a more extensive range of endometrial cancer patients marks a pivotal advancement in treatment options, offering a new hope for individuals battling this common and challenging form of cancer. With this expanded authorization, GSK continues to establish itself as a leader in developing innovative therapies that improve patient outcomes and survival rates in the fight against cancer.