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GSK's Jemperli Plus Chemo Approved in Europe for Frontline dMMR/MSI-H Endometrial Cancer

NEW YORK – The European Commission on Monday approved GSK's 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.

The EC also converted the conditional approval of Jemperli monotherapy for dMMR or MSI-high recurrent or advanced endometrial cancer that has progressed on or following prior treatment with a platinum-containing regimen to full approval.

The Jemperli-chemo approval was based on results from the Phase III RUBY/ENGOT-EN6/GOG3031/NSGO trial. Those data showed the Jemperli combination reduced the risk of disease progression or death by 72 percent against chemo and placebo. Overall survival at 24 months in the study was 71 percent on Jemperli and chemo compared to 56 percent on chemo alone.

Hesham Abdullah, senior VP and global head of oncology development at GSK, said the approval "can expand the number of patients who can potentially benefit from treatment with Jemperli in Europe, including patients who are earlier in their journey."

"People living with this type of endometrial cancer typically experience disease progression and poor long-term outcomes with current standard of care," Abdullah said in a statement.

Earlier this year, the US Food and Drug Administration also granted approval to the Jemperli-chemo combination in the same endometrial cancer patient population.