GSK has received full approval from the US Food and Drug Administration (FDA) for its programmed death receptor-1 (PD-1)-blocking antibody Jemperli (dostarlimab-gxly) to treat adults with mismatch repair-deficient (dMMR) recurrent or advanced endometrial cancer.
Jemperli has been designed to attach to the PD-1 receptor and blocks its interaction with the PD-L1 and PD-L2 ligands.
The antibody received accelerated approval in April 2021 to treat adult patients with dMMR recurrent or advanced endometrial cancer that had progressed on or following previous platinum-containing regimen treatment.
GSK Oncology Development senior vice-president, global head Hesham Abdullah said: “This US regulatory action confirms our confidence in Jemperli as an important treatment option for patients with dMMR recurrent or advanced endometrial cancer.
“We continue to unlock the potential of Jemperli as the backbone for our immuno-oncology development programmes to address the unmet needs of patients, including earlier lines of endometrial cancer and other solid tumours.”
The latest approval is based on additional data obtained from the A1 expansion cohort of the GARNET Phase I, multicentre, open-label, single-arm trial underway evaluating Jemperli monotherapy in patients with advanced or recurrent solid tumours.
Cohort A1 assessed Jemperli’s efficacy in 141 dMMR advanced or recurrent endometrial cancer patients.
Overall response rate (ORR) and duration of response (DOR) were the major efficacy outcome measures as assessed by a blinded independent central review according to RECIST v1.1.
Treatment-related adverse events in the trial were found to be consistent with previous analyses for cohort A1.
The most common adverse reactions reported were anaemia, rash, fatigue/asthenia, nausea, diarrhoea, constipation, and vomiting.