GSK Reports EMA’s Validation of MAA for Jemperli (dostarlimab) to Treat dMMR/MSI-H Primary Advanced or Recurrent Endometrial Cancer
- The EMA has validated the Type II variation MAA for Jemperli (PD-1-blocking Ab) to treat patients with dMMR/MSI-H primary advanced or recurrent endometrial cancer in combination with CT
- The submission was based on the interim results from the two-part P-III trial (RUBY/ENGOT-EN6/GOG3031/NSGO) evaluating dostarlimab + carboplatin-paclitaxel vs PBO + CT. The trial met its 1EPs of investigator-assessed PFS & showed a clinical benefit in the dMMR/MSI-H population
- The safety & tolerability profiles were consistent with the known safety profiles of the individual agents & the results were presented at ESMO Virtual Plenary & the SGO 2023 and published in NEJM. The US regulatory filing review is expected in H1’23, based on the P-III trial results
Ref: GSK | Image: GSK
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