NEW YORK – The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) on Friday recommended approval for GlaxoSmithKline's anti-PD-1 antibody dostarlimab for patients with mismatch repair deficient (dMMR) and microsatellite instability-high (MSI-H) recurrent or advanced endometrial cancer.
The CHMP opinion is based on data from the Phase I/II GARNET study evaluating dostarlimab as a monotherapy to treat endometrial cancer that had progressed during or after platinum-based treatment. Data presented last year from that study showed a 42 percent objective response rate among 71 evaluable patients with dMMR endometrial cancer; the disease control rate was 58 percent, 13 percent experienced a complete response, and 30 percent had a partial response.
"Treatment options are limited for women with recurrent or advanced endometrial cancer and prognosis is typically poor," Axel Hoos, head of oncology R&D at GSK, said in a statement. "If approved by the European Commission, dostarlimab would be the first anti-PD-1 therapy approved for endometrial cancer in Europe."
Dostarlimab, which came to GSK through its acquisition of Tesaro in 2019, is also being reviewed by the US Food and Drug Administration for both dMMR endometrial cancer and dMMR recurrent or advanced solid tumors.
GSK is continuing to study dostarlimab in combination with other drugs. For example, GSK is evaluating dostarlimab with its PARP inhibitor niraparib (Zejula) in ovarian cancer patients who don't have a BRCA1/2 mutation.