- The FDA has granted full approval to GSK plc’s GSK Jemperli (dostarlimab-gxly) for mismatch repair-deficient (dMMR) recurrent or advanced endometrial cancer.
- The approval covers patients who progressed on or following a prior platinum-containing regimen in any setting and are not candidates for curative surgery or radiation.
- In April 2021, Jemperli received accelerated approval.
- The approval is based on additional data from the A1 expansion cohort of the ongoing GARNET trial, a phase 1 study of Jemperli monotherapy in patients with advanced or recurrent solid tumors.
- Related: FDA Approves First Oral Treatment For Anemia Due To Chronic Kidney Disease.
- Cohort A1 evaluated the efficacy of Jemperli in 141 patients with dMMR advanced or recurrent endometrial cancer that has progressed on or following prior treatment with a platinum-containing regimen.
- The major efficacy outcome measures were overall response rate (ORR) and duration of response (DOR).
- The confirmed overall response rate (ORR) was 45.4%, with a 15.6% complete response rate and a 29.8% partial response rate.
- 85.9% of patients had a duration of response ≥12 months and 54.7% of patients had a duration of response ≥24 months.
- Price Action: GSK shares are down 1.24% at $35.98 during the premarket session on the last check Friday.
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