GSK’s PD-1 Inhibitor Jemperli Approved in Singapore as First-Line Therapy for dMMR/MSI-H Advanced or Recurrent Endometrial Cancer, Reducing Risk of Progression or Death by 72%
GSK
Pharmaceutical R&D Manufacturer
News on August 7,GlaxoSmithKline (GSK)GSK announces that the Health Sciences Authority (HSA) of Singapore has approved a new indication for Jemperli (dostarlimab), to be used in combination with carboplatin and paclitaxel, followed by Jemperli as a monotherapy for treatment.Patients with primary advanced or recurrent endometrial cancer, these patients have mismatch repair deficiency (dMMR) or high microsatellite instability (MSI-H).
According to the GSK press release, this approval enablesJemperli Becomes Singapore'sdMMR/MSI-H Primary Advanced or Recurrent Endometrial CancerThe first-line immunooncology therapeutic agent,Can be used for the early treatment of such patientsJemperli has previously been approved by Singapore's HSA as a treatment for adult patients with dMMR recurrent or advanced endometrial cancer.Monotherapy, these patients progressed during or after prior platinum-containing regimens and are not candidates for curative surgery or radiotherapy.
Dostarlimab (trade name: Jemperli) is a programmed death receptor-1 (PD-1) blocking antibody that binds to the PD-1 receptor and blocks its interaction with the PD-1 ligands PD-L1 and PD-L2.The product was first introduced inApril 2021FDA Accelerated Approval, followed by the approval of multiple tumor indications, coveringdMMR Advanced or RecurrentEndometrial Cancer、dMMR or MSI-H primary advanced or recurrentEndometrial cancer,dMMR recurrent or advanced solid tumors,All primary advanced or recurrent endometrial cancersAdult patients.
The documents submitted by GSK to the Singapore regulatory authority this time includePhase 3Interim analysis results of the first part of the RUBY/ENGOT-EN6/GOG3031/NSGO trial, with a median follow-up time of 25 months. The trial met its primary endpoint of investigator-assessed progression-free survival (PFS), demonstrating a statistically significant and clinically meaningful benefit in the dMMR/MSI-H population receiving Jemperli plus carboplatin and paclitaxel.In the dMMR/MSI-H population, a 72% reduction in the risk of disease progression or death was observed.The safety and tolerability of Jemperli in combination with carboplatin and paclitaxel are generally consistent with the known safety profiles of the individual drugs.
Dr. Stephanie Cinthu Stephen Ambrose, Medical Director of GSK Singapore, stated: "The expanded regulatory approval of Jemperli in Singapore redefines the treatment landscape for patients with dMMR/MSI-H primary advanced or recurrent endometrial cancer in Singapore. Until now, chemotherapy has been the standard treatment for many patients with disease progression. In GSK's RUBY trial, Jemperli + chemotherapy demonstrated a 72% reduction in the risk of disease progression or death compared to chemotherapy alone in this patient population, offering statistically significant and clinically meaningful benefits. These results highlight the potential of Jemperli to transform cancer treatment into a backbone immunotherapy."
References:
[1]GSK's Jemperli (dostarlimab) plus chemotherapy approved in Singapore as the first frontline immuno-oncology treatment for dMMR/MSI-H primary advanced or recurrent endometrial cancer. Retrieved Aug 7，2024,from https://en.prnasia.com/releases/apac/gsk-s-jemperli-dostarlimab-plus-chemotherapy-approved-in-singapore-as-the-first-frontline-immuno-oncology-treatment-for-dmmr-msi-h-primary-advanced-or-recurrent-endometrial-cancer-456494.shtml
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