GSK’s PD-1 inhibitor Jemperli approved in the UK

GlaxoSmithKline’s (GSK) PD-1 inhibitor Jemperli has been authorised by the UK Medicines and Healthcare products Regulatory Agency (MHRA) for the treatment of recurrent or advanced endometrial cancer. Specifically, Jemperli (dostarlimab) has been granted a conditional marketing authorisation for use in adult patients with mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) recurrent or advanced endometrial cancer, who have progressed on or following prior treatment with a platinum containing regimen. The authorisation is based on results from the open-label GARNET study, which included women with recurrent or advanced dMMR/MSI-H endometrial cancer who progressed on or after a platinum-based chemotherapy regimen. Jemperli treatment led to an objective response rate of 44.8% and a disease control rate of 57.1%, while a median duration of response (DoR) had not been reached in these patients. However, the probability of maintaining a response at six months and 12 months was 97.9% and 90.9% respectively, according to ...

• Source: drugdu
• 287
• June 7, 2021