FDA Grants Accelerated Approval to GSK’s PD-1 Antibody Jemperli for dMMR Recurrent or Advanced Solid Tumors

Today, GlaxoSmithKline (GSK) announced that the U.S. FDA has granted accelerated approval for an expanded indication of the company's PD-1 antibody Jemperli (dostarlimab-gxly) for the treatment of patients with recurrent or advanced solid tumors harboring mismatch repair deficiency (dMMR). These patients must have their dMMR status confirmed by an FDA-approved test, have experienced disease progression following prior treatment, and have no satisfactory alternative treatment options. This marks the second indication for Jemperli to receive FDA approval this year.

Cells of mismatch repair-deficient tumors exhibit impaired repair of DNA damage during DNA replication. It is a predictive biomarker for response to immune checkpoint inhibitors. Tumors harboring this biomarker are predominantly found in endometrial cancer, colorectal cancer, and gastrointestinal cancers, but may also occur in other solid tumors.

This approval was based on results from the GARNET clinical trial. The results showed that, in all patients with dMMR solid tumors, Jemperli achieved an objective response rate of 41.6% (95% CI: 34.9–48.6) and a complete response rate of 9.1%. The median duration of response was 34.7 months, with 95.4% of patients maintaining a response for more than 6 months.

References:

[1] FDA Grants Accelerated Approval of JEMPERLI (dostarlimab-gxly) for dMMR Recurrent or Advanced Solid Tumors. Retrieved August 17, 2021, from https://www.globenewswire.com/news-release/2021/08/17/2282311/0/en/FDA-Grants-Accelerated-Approval-of-JEMPERLI-dostarlimab-gxly-for-dMMR-Recurrent-or-Advanced-Solid-Tumors.html

[2] GSK receives FDA accelerated approval for JEMPERLI (dostarlimab-gxly) for adult patients with mismatch repair-deficient (dMMR) recurrent or advanced solid tumours. Retrieved August 17, 2021, from https://www.gsk.com/en-gb/media/press-releases/gsk-receives-fda-accelerated-approval-for-jemperli-dostarlimab-gxly-for-adult-patients-with-mismatch-repair-deficient-dmmr-recurrent-or-advanced-solid-tumours/

(Original text abridged)

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