GlaxoSmithKline (GSK) has achieved a significant milestone in the fight against endometrial cancer as the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issues a positive opinion, recommending the approval of Jemperli (dostarlimab) in combination with chemotherapy for the treatment of patients with mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) primary advanced or recurrent endometrial cancer.
If approved by the European Commission, this groundbreaking treatment option will mark the first new frontline therapy for this patient population in decades within the European Union (EU). This news comes as a ray of hope for patients with high unmet medical needs.
Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D, GSK, expressed their pleasure at the positive CHMP opinion. Dostarlimab combined with chemotherapy offers new hope for improved long-term outcomes, with the potential to reduce the risk of disease progression or death by 72% in the dMMR/MSI-H population.
This recommendation is based on the interim analysis results from Part 1 of the RUBY/ENGOT-EN6/GOG3031/NSGO phase III trial, which demonstrated a robust median duration of follow-up of over 25 months and achieved the primary endpoint of investigator-assessed progression-free survival (PFS). Additionally, an exploratory analysis revealed a 70% reduction in the risk of death with the addition of dostarlimab to chemotherapy.
The safety and tolerability profile of dostarlimab combined with carboplatin and paclitaxel was generally consistent with known safety profiles. Common adverse reactions included rash, hypothyroidism, and increased liver enzyme levels.
In July 2023, the U.S. expanded Jemperli’s label to include this indication, following approval in the United Kingdom. The application is still under review in several other countries.
Currently, Jemperli has conditional approval as a monotherapy for treating adult patients with dMMR/MSI-H recurrent or advanced endometrial cancer. If approved for the frontline indication, this conditional approval is expected to be converted to full approval by the end of this year.
Endometrial cancer, the most common gynecologic cancer in developed countries, affects a significant number of patients, with a portion being diagnosed with advanced disease. This approval represents a significant step forward in addressing the medical needs of this patient population.
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