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FDA Approves GlaxoSmithKline's Jemperli, Roche’s Ventana CDx for dMMR Solid Cancers

NEW YORK – The US Food and Drug Administration on Tuesday granted accelerated approval to GlaxoSmithKline's anti-PD-1 agent dostarlimab-gxly (Jemperli) for patients with previously treated, mismatch repair-deficient, or dMMR, solid cancers.

The FDA also approved Roche's Ventana MMR RxDx immunohistochemistry panel as a companion diagnostic to select patients for treatment with dostarlimab. 

The approval marks the second indication for dostarlimab, which received approval in both the US and Europe for dMMR recurrent or advanced endometrial cancer in April 2021. At the time, the FDA also approved Roche's Ventana MMR RxDx immunohistochemistry panel as a companion diagnostic to select endometrial cancer patients for treatment with dostarlimab. That approval expanded the label for the Ventana MMR IHC panel, which was initially approved in 2017 to screen colorectal cancer patients for dMMR and Lynch syndrome.

The FDA based its decision to approve dostarlimab on results from cohorts A1 and F of the ongoing Phase I/II GARNET trial. Cohort A1 specifically enrolled patients with dMMR endometrial cancers, while cohort F included patients with non-endometrial dMMR cancers, the most prevalent of which were colorectal, small intestine, and stomach cancers.

Among 209 patients with both endometrial and non-endometrial dMMR solid tumors, the objective response rate with dostarlimab was 41.6 percent, and the complete response rate was just over 9 percent. The median duration of response was 34.7 months, and over 95 patients were still responding to the agent after six months. Among 106 patients with non-endometrial cancers specifically, the objective response rate was 38.7 percent.

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