FDA approves Jemperli for mismatch repair-deficient endometrial cancer.- GlaxoSmithKline

This approval is based on additional data collected from the A1 expansion cohort of the ongoing GARNET trial, a phase I, multicenter, open-label, single-arm study of Jemperli monotherapy in patients with advanced or recurrent solid tumors. 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) as assessed by a blinded independent central review according to RECIST v1.1. Confirmed ORR was 45.4% (95% CI: 37.0, 54.0), with a 15.6% complete response rate and a 29.8% partial response rate. Median DOR was not reached (range: 1.2+, 52.8+ months), measured from the time of first response, with 85.9% of patients having duration of at least 12 months and 54.7% of patients having duration of at least 24 months. Median follow-up for duration of response was 27.9 months. Treatment-related adverse events were consistent with previous analyses for cohort A1.

In April 2021, Jemperli received accelerated approval for the treatment of adult patients with dMMR recurrent or advanced endometrial cancer that had progressed on or following prior treatment with a platinum-containing regimen.