GSK (GlaxoSmithKline) has announced encouraging results from Part 1 of the RUBY/ENGOT-EN6/GOG3031/NSGO Phase III trial evaluating Jemperli (dostarlimab) in combination with standard chemotherapy for patients with primary advanced or recurrent endometrial cancer. The trial successfully met its primary endpoint of overall survival (OS), indicating a statistically significant and clinically meaningful benefit for patients.
In this groundbreaking study, Jemperli was administered alongside standard chemotherapy, followed by a single-agent treatment of Jemperli. This combination demonstrated a substantial OS advantage for patients with primary advanced or recurrent endometrial cancer, highlighting its potential as a promising treatment option.
The trial yielded promising results in two prespecified subpopulations: mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) patients and mismatch repair proficient (MMRp)/microsatellite stable (MSS) patients. The survival benefit observed in these groups underlines the potential impact of Jemperli across different patient profiles.
Hesham Abdullah, Senior Vice President of Global Head Oncology at GSK, expressed the significance of these findings, noting that Jemperli plus chemotherapy stands out as the only immunotherapy combination to demonstrate a survival benefit in this broader patient population within this treatment context. The results of this analysis will be shared with regulatory authorities and the scientific community, further advancing the understanding of this novel therapeutic approach.
The safety profile of Jemperli in combination with carboplatin and paclitaxel was consistent with the known safety profiles of the individual agents. Common treatment-related adverse events included nausea, alopecia, fatigue, peripheral neuropathy, anemia, arthralgia, constipation, diarrhea, and myalgia.
Jemperli has already received regulatory approvals for specific subsets of patients with endometrial cancer based on previously reported positive results for progression-free survival. In July 2023, it obtained FDA approval for use in combination with carboplatin and paclitaxel, followed by Jemperli as a single agent, for the treatment of adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H). It was also approved in the UK in October 2023 for patients with dMMR/MSI-H primary advanced or recurrent endometrial cancer who are candidates for systemic therapy. Regulatory reviews are ongoing in the European Union (EU), Australia, Canada, Switzerland, and Singapore.
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