GSK’s Jemperli (dostarlimab-gxly) Receives the US FDA’s Approval for Recurrent or Advanced Mismatch Repair-Deficient Endometrial Cancer
Shots:
- 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
Click here to read the full press release
Tags
Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.
