GSK's Jemperli Approved for Advanced Endometrial Cancer in Singapore

GSK Singapore has received approval from the Singapore Health Sciences Authority (HSA) for a new indication for its drug Jemperli (dostarlimab), aimed at treating advanced or recurrent endometrial cancer. This approval introduces a new treatment regimen that combines Jemperli with chemotherapy agents, specifically carboplatin and paclitaxel, to be used for patients exhibiting mismatch repair deficiency (dMMR) or microsatellite instability-high (MSI-H) in their cancer.

Jemperli functions as a programmed death receptor-1 (PD-1)-blocking antibody. By attaching to the PD-1 receptor, it obstructs interactions with its ligands, PD-L1 and PD-L2, thereby potentially enhancing the immune system's ability to combat cancer cells. This new indication expands the use of Jemperli to an earlier stage in the treatment process, providing a frontline immuno-oncology option for patients with dMMR or MSI-H endometrial cancer.

Previously, Jemperli had been authorized as a monotherapy for patients with recurrent or advanced endometrial cancer who had already undergone a platinum-containing chemotherapy regimen. The expanded approval now allows it to be used in combination with other chemotherapy drugs, offering a more comprehensive treatment approach.

The HSA's decision was heavily influenced by interim results from the RUBY Phase III clinical trial, which evaluated the efficacy of dostarlimab in combination with chemotherapy. The trial demonstrated a 72% reduction in the risk of disease progression or death in patients with dMMR or MSI-H endometrial cancer. Part 1 of the trial met its primary endpoint of progression-free survival (PFS) and confirmed that the safety profile of the combined treatment was consistent with the known risks associated with the individual therapies.

Dr. Stephanie Cinthu Stephen Ambrose, GSK Singapore's medical director, commented on the expanded regulatory approval, stating that it redefines the treatment landscape for patients with dMMR/MSI-H primary advanced or recurrent endometrial cancer in Singapore.

Jemperli was originally discovered by AnaptysBio and was later licensed to TESARO in 2014 under an exclusive agreement. The therapy has shown promising results in the treatment of endometrial cancer by blocking the interaction between the PD-1 receptor and its ligands, thereby enhancing the immune system's response against cancer cells.

In addition to its approval in Singapore, Jemperli has also been authorized by the UK Medicines and Healthcare products Regulatory Agency (MHRA) for treating adult patients with specific types of endometrial cancer as of October 2023. This broadens the availability of the drug and offers new hope for patients battling this challenging form of cancer.

The new indication for Jemperli provides an important option for patients whose cancers exhibit specific genetic markers, thereby enhancing the overall treatment strategy for endometrial cancer. With this approval, GSK Singapore continues to advance its portfolio of cancer therapies, providing new and effective treatment options for patients in need.

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