Endometrial cancer treatment options may expand as the European Medicines Agency (EMA) has accepted GlaxoSmithKline’s (GSK) application to use Jemperli (dostarlimab) in combination with standard-of-care chemotherapy (carboplatin and paclitaxel) for all adult patients with primary advanced or recurrent endometrial cancer.
This regulatory submission is supported by statistically significant and clinically meaningful progression-free and overall survival data from Part 1 of the phase III RUBY trial. The EMA’s Committee for Medicinal Products for Human Use will begin the formal review process to make a recommendation to the European Commission, with approval expected in the first half of 2025.
Endometrial Cancer Treatment Expansion: Jemperli to Potentially Include All Patients Regardless of Biomarker Type
Currently, in the EU, Jemperli combined with carboplatin and paclitaxel is approved for the treatment of adult patients who are candidates for systemic therapy with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H). If this new application is approved, dostarlimab would be expanded to all patients with primary advanced or recurrent endometrial cancer, regardless of their biomarker type, including those with mismatch repair proficient (MMRp)/microsatellite stable (MSS) tumors where there are currently no approved frontline immunotherapy-based treatments in the EU.
The application is based on results from Part 1 of the RUBY phase III trial. The trial met its primary endpoints of investigator-assessed progression-free survival (PFS) and overall survival (OS), demonstrating a statistically significant and clinically meaningful benefit in the overall population of patients treated with dostarlimab plus carboplatin-paclitaxel versus chemotherapy alone. RUBY Part 1 is the only clinical trial to show a statistically significant overall survival benefit in this patient population. The safety and tolerability analyses from RUBY showed a safety profile for dostarlimab plus carboplatin-paclitaxel that was generally consistent with the known safety profiles of the individual agents.
Endometrial Cancer: Increasing Incidence and Advanced Disease Prevalence in Europe
Endometrial cancer is found in the inner lining of the uterus, known as the endometrium. Endometrial cancer is the most common gynecologic cancer in developed countries, with approximately 417,000 new cases reported each year worldwide, and incidence rates are expected to rise by almost 40% between 2020 and 2040. In Europe, approximately 121,000 people are estimated to be diagnosed with primary advanced or recurrent endometrial cancer each year. Approximately 15-20% of patients with endometrial cancer will be diagnosed with advanced disease at the time of diagnosis. Among patients with primary advanced or recurrent endometrial cancer, approximately 70-75% have MMRp/MSS tumors.
Jemperli (dostarlimab) is an immunotherapy drug that works by blocking the programmed death-1 (PD-1) receptor, which allows the immune system to target and destroy cancer cells. The approval of dostarlimab for use in combination with chemotherapy represents a significant advancement in the treatment of endometrial cancer, offering a new option for patients who have limited treatment choices. This development underscores GSK’s commitment to advancing cancer care and improving outcomes for patients with challenging cancers.
The RUBY trial’s success in demonstrating the efficacy of dostarlimab in combination with chemotherapy highlights the potential for immunotherapy to enhance the effectiveness of existing cancer treatments. This combination therapy approach aims to provide a more comprehensive attack on cancer cells, improving patient outcomes and potentially extending survival rates. As the EMA review progresses, the oncology community remains hopeful that this new treatment option will soon be available to a broader range of patients with endometrial cancer, marking a significant step forward in the fight against this disease.
Resource: Glaxo Smith Kline, June 24, 2024
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