Dostarlimab-gxly Receives FDA Accelerated Approval for Adult Patients with dMMR Recurrent, Advanced Solid Tumors

The continued approval for this indication may be subject upon verification and description of clinical benefit in a confirmatory trial.

The FDA has approved a new indication for dostarlimab-gxly (Jemparli, GlaxoSmithKline) for the treatment of adult patients with mismatch repair-deficient (dMMR) recurrent or advanced solid tumors, as determined by an FDA-approved test, that have progressed on or following prior treatment, and who have no satisfactory alternative treatment options, according to a press release.

The accelerated approval was based on tumor response rate and durability of response. The continued approval for this indication may be subject upon verification and description of clinical benefit in a confirmatory trial.

“For patients with tumors expressing the dMMR biomarker, there continues to be a significant need for new and effective treatments,” said Hal Barron, MD, chief scientific officer and president of R&D, GSK, in the press release. “I’m excited about GSK’s second oncology FDA approval this year, and the new treatment option it provides for these patients.”

Mismatch repair-deficient status is a biomarker that has been shown to predict response to immune checkpoint blockade with PD-1 therapy, and tumors with this biomarker are most commonly found in endometrial, colorectal, and other gastrointestinal cancers, but may also be found in other solid tumors, according to the release.

“Dostarlimab is an important new treatment option for patients with mismatch repair-deficient recurrent or advanced solid cancers who have progressed and have no alternative options,” said Jubilee Brown, MD, professor and division director of gynecologic oncology at Atrium Health Levine Cancer Institute, in the release. “As we saw in the GARNET trial, of those patients who respond to treatment with dostarlimab, nearly all continued to respond for six months or longer.”

The new indication is based on the combination from results from the dMMR endometrial cancer cohort, the ongoing GARNET trial, and FDA priority review of the Biologics License Application. The GARNET trial demonstrated an overall response rate of 41.6% with a complete response rate of 9.1% and a partial response rate of 32.5%.

The FDA granted accelerated approval to 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.

REFERENCE

GSK receives FDA accelerated approval for JEMPERLI (dostarlimab-gxly) for adult patients with mismatch repair-deficient (dMMR) recurrent or advanced solid tumours. GSK. August 17, 2021. Accessed August 17, 2021.