GSK planning BLA for dostarlimab in endometrial cancer

GSK plans to submit a BLA to FDA at the end of the year for dostarlimab (formerly TSR-042) to treat endometrial cancer after reporting that the humanized anti-PD-1 mAb as monotherapy led to an overall response rate (ORR) of 30% using irRECIST criteria in the Phase I/II GARNET trial. GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) said further data from GARNET will be analyzed using RECIST 1.1 criteria to support the BLA.

FDA has expressed concerns over the possibility that benefits of immunotherapies are not fully captured by existing RECIST 1.1 criteria. The agency has been working with EMA and other stakeholders to develop new response criteria, like irRECIST, under which new lesions are added to the original index of lesions to calculate total tumor burden, and is then used to determine response, stable disease or progression (see "Rethinking RECIST for Immunotherapies")...