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Jemperli Combination with Chemotherapy Receives Frontline Approval in Europe for dMMR/MSI-HEndometrial Cancer

NextEdge Admin

12 Nov 2023

1 min 59 sec

The European Commission granted approval for GlaxoSmithKline’s (GSK) anti-PD-1 therapy Jemperli (dostarlimab) in combination with chemotherapy as a frontline treatment for patients with mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-high) primary advanced or recurrent endometrial cancer. Additionally, the conditional approval of Jemperli monotherapy for dMMR or MSI high recurrent or advanced endometrial cancer was converted to full approval.

The approval was based on Phase III RUBY/ENGOT-EN6/GOG3031/NSGO trial data, demonstrating a 72 percent reduction in the risk of disease progression or death with the Jemperli combination compared to chemotherapy and placebo. The study also showed a 71 percent overall survival at 24 months with Jemperli and chemotherapy, compared to 56 percent with chemotherapy alone. Hesham Abdullah, Senior VP and Global Head of Oncology Development at GSK, emphasized that this approval could extend the benefits of Jemperli to a broader patient population in Europe, particularly those in the early stages their cancer journey. Abdullah noted that patients with this type of endometrial cancer typically face disease progression and poor long-term outcomes with the current standard of care. Earlier in the year, the US Food and Drug Administration also approved the Jemperli chemo combination for the same endometrial cancer patient population.