GlaxoSmithKline group Tesaro has presented mid-stage data indicating “robust activity” of its anti-PD-1 therapy dostarlimab in patients with advanced or recurrent endometrial cancer, with a filing now on the cards for later this year.
Preliminary findings from the GARNET study show “clinically meaningful and durable” response rates of dostarlimab (formerly TSR-042) in patients who progressed on or after a platinum-based regimen, regardless of microsatellite instability status.
Overall response rates in the full population, MSI-H population, and MSS population were 30%, 49%, and 20%, respectively.
Disease control rate in the full population, microsatellite instability-high (MSI-H) population, and microsatellite stable (MSS) population was 53%, 63% and 47%, respectively.
Also of note, the safety findings indicate that dostarlimab is well tolerated with a safety profile consistent with what is expected of anti-PD-1 therapy, GSK noted.
Further data from study will be analysed to support regulatory filing for the drug in endometrial cancer at the end of this year.
“Currently, treatment options for women with advanced or recurrent endometrial cancer are limited, with only one FDA-approved agent for a subset of these patients,” said Mary Lynne Hedley, Tesaro’s president and chief operating officer.
“We intend to use these and other data from the GARNET study to seek regulatory approval of dostarlimab to potentially address the critical unmet treatment needs of women whose disease has progressed.”