GSK's PD-1 Inhibitor Jemperli Receives Conditional Approval in the UK for dMMR/MSI-H Recurrent or Advanced Endometrial Cancer
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Recently, GSK’s PD-1 inhibitor Jemperli (dostarlimab) received conditional approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for the treatment of recurrent or advanced endometrial cancer. Jemperli is a PD-1 blocking antibody specifically indicated for patients with recurrent or advanced endometrial cancer characterized by mismatch repair deficiency (dMMR) or microsatellite instability-high (MSI-H) status, who have experienced disease progression during or following treatment with a platinum-based chemotherapy regimen.
This approval is based on positive results from the open-label, single-arm, multi-cohort Phase 1/2 GARNET study (NCT02715284). In this study, Cohort A1 enrolled patients with dMMR/MSI-H recurrent or advanced endometrial cancer who experienced disease progression during or after treatment with a platinum-based chemotherapy regimen. In this cohort, the objective response rate (ORR) and disease control rate (DCR) for Jemperli monotherapy were 44.8% and 57.1%, respectively; the median duration of response (DOR) has not been reached, and the probability of maintaining response at 6 and 12 months was 97.9% and 90.9%, respectively.
Dr Rebecca Kristeleit, Oncology Consultant at Guy's and St Thomas' NHS Foundation Trust (GSTT), said: “The UK regulatory approval of Jemperli adds an important new option for women with hard-to-treat endometrial cancer. Historically, patients with advanced or recurrent dMMR/MSI-H endometrial cancer have had limited treatment options and a poor prognosis. Today’s approval will help address the significant unmet need in this patient population for effective and well-tolerated therapies.”
Currently, GlaxoSmithKline is also conducting other registration studies to evaluate Jemperli as a monotherapy and as part of combination therapy for the treatment of patients with recurrent or primary advanced endometrial cancer and patients with non-mucinous epithelial ovarian cancer.
Jemperli belongs to the PD-(L)1 inhibitor family, a class of cancer immunotherapies designed to harness the body’s own immune system to combat cancer. To date, more than 10 PD-(L)1 inhibitors have received marketing approval, with Merck’s Keytruda as the market leader.
Among these agents, Jemperli is the first PD-(L)1 inhibitor to receive regulatory approval for the treatment of endometrial cancer. Currently, the combination regimen of Merck’s Keytruda and Eisai’s Lenvima is under regulatory review. Results from the Phase 3 KEYNOTE-775 trial demonstrated that, regardless of mismatch repair status, the Keytruda plus Lenvima regimen showed significantly superior efficacy compared to chemotherapy: significantly prolonging overall survival and progression-free survival, and improving response rates.
Source: GSK’s PD-1 inhibitor Jemperli approved in the UK
*Disclaimer: This article was written by a contributor to Sina Pharmaceutical News. The views expressed are solely those of the author and do not represent the position of Sina Pharmaceutical News.