GSK Singapore has obtained the Singapore Health Sciences Authority’s (HSA) approval for a new indication for Jemperli (dostarlimab) for use with chemotherapy in treating advanced or recurrent endometrial cancer.
The programmed death receptor-1 (PD-1)-blocking antibody Jemperli attaches to the PD-1 receptor and blocks its interaction with the PD-L1 and PD-L2 ligands.
The approval allows for the use of Jemperli, in combination with carboplatin and paclitaxel, for patients with mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) endometrial cancer.
It expands Jemperli’s indication to an earlier stage in treatment, offering a new frontline immuno-oncology option.
It was previously approved as monotherapy for dMMR recurrent or advanced endometrial cancer patients after a platinum-containing regimen.
The recent decision by the Singapore HSA is based on interim analysis from the RUBY Phase III trial, which showed a 72% reduction in disease progression or death risk in the dMMR/MSI-H population.
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The trial is a comprehensive study evaluating dostarlimab in combination with chemotherapy.
Part 1 of the trial, which informed the HSA’s decision, met its primary endpoint of progression-free survival (PFS) and demonstrated a safety profile consistent with the known risks of the individual therapies.
Jemperli has shown positive results in treating endometrial cancer by blocking the interaction between the PD-1 receptor and its ligands.
GSK Singapore medical director Dr Stephanie Cinthu Stephen Ambrose stated: “Singapore’s expanded regulatory approval of Jemperli redefines the treatment landscape for patients with dMMR/MSI-H primary advanced or recurrent endometrial cancer in Singapore.”
The therapy was originally discovered by AnaptysBio and licensed to TESARO under an exclusive licence agreement signed in 2014.
In October 2023, the UK Medicines and Healthcare products Regulatory Agency (MHRA) authorised Jemperli to treat adult patients with certain types of endometrial cancer.
