GSK receives FDA accelerated approval for Jemperli

This indication received accelerated approval based on tumour response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

This new indication follows an FDA priority review of the Biologics License Application and is based on the collective results from the dMMR endometrial cancer cohort A1 and the dMMR solid-tumour (non-endometrial cancer) cohort F of the ongoing GARNET trial. The GARNET trial is a multicentre, non-randomised, multiple parallel-cohort, open-label study. Cohort F included patients with dMMR recurrent or advanced non-endometrial cancers, with the highest prevalence in colorectal, small intestine and stomach cancers.

The major efficacy outcomes of the GARNET trial are objective response rate (ORR) and duration of response (DoR), as assessed against RECIST v 1.1 by blinded independent central review. Results in all dMMR solid tumours, including endometrial and non-endometrial solid tumours (n=209), demonstrated an ORR of 41.6% (95% CI; 34.9-48.6) with a complete response rate of 9.1% and a partial response rate of 32.5%. The median DoR was 34.7 months (range 2.6-35.8+) with 95.4% of patients maintaining a response for six months or longer. In the dMMR solid tumour non-endometrial cancer cohort (n=106), results demonstrated an ORR of 38.7% (95% CI; 29.4-48.6).

In April 2021, the FDA granted accelerated approval for dostarlimab for the treatment of adult patients with dMMR recurrent or advanced endometrial cancer, as determined by an FDA-approved test, that have progressed on or following prior treatment with a platinum-containing regimen. This approval was based on data from cohort A1, which included 71 patients with dMMR endometrial cancer.