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

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

June 7, 2021  Source: drugdu 167

Image

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 GSK.

“The licensing of [Jemperli] in the UK adds an important new option for a difficult to treat women’s cancer. Patients with dMMR/MSI-H advanced or recurrent endometrial cancer have been historically underserved, with limited treatment options and a poor prognosis,” said Dr Rebecca Kristeleit, consultant medical oncologist, Guy’s and St Thomas’ NHS Foundation Trust.

“Today’s announcement will help to address the significant unmet need for effective tolerable treatment in this patient group," she added.

GSK is also studying Jemperli in other registrational-enabling studies, as monotherapy and as part of combination regimens for women with recurrent or primary advanced endometrial cancer or non-mucinous epithelial ovarian cancer for patients with advanced solid tumours or metastatic cancer.

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