GSK’s Jemperli (dostarlimab-gxly) Receives the US FDA’s Approval for Recurrent or Advanced Mismatch Repair-Deficient Endometrial Cancer
- The US FDA has granted full approval for Jemperli in recurrent or advanced dMMR advanced endometrial cancer that has progressed on or after a prior Pt-containing regimen in any setting and are not a candidates for curative surgery or radiation.
- The approval was based on additional data from the A1 expansion cohort of an ongoing P-I trial (GARNET) evaluating Jemperli monotx. Patients in cohort A1 received Jemperli (500mg, IV, q3w) for 4 doses, followed by 1000mg, q6w
- The results showed ORR (45.4%) with CR rate (15.6%) & PR rate (29.8%), m-DoR was not reached, and patients had a duration of response ≥1 & ≥2yrs. (85.9% & 54.7%), median follow-up for DoR was 27.9mos., TRAEs were consistent with prior analyses for cohort A1
Ref: PRNewswire | Image: GSK
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