GSK Singapore secures HSA approval for expanded use of Jemperli in endometrial cancer treatment

SINGAPORE — GSK Singapore has received approval from the Singapore Health Sciences Authority (HSA) for a new indication for Jemperli (dostarlimab), expanding its use in treating advanced or recurrent endometrial cancer.

The newly approved indication allows Jemperli to be used in combination with chemotherapy, specifically carboplatin and paclitaxel, for patients with mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) endometrial cancer.

Jemperli is a programmed death receptor-1 (PD-1)- blocking antibody that attaches to the PD-1 receptor and inhibits its interaction with the PD-L1 and PD-L2 ligands. This mechanism effectively enhances the immune system’s ability to fight cancer cells.

This is a critical development as it extends the use of Jemperli to an earlier stage in treatment, offering a frontline immuno-oncology option for patients who previously had limited alternatives.

Previously, Jemperli had been approved as a monotherapy for patients with dMMR recurrent or advanced endometrial cancer who had already undergone a platinum-containing regimen.

However, this new approval allows the drug to be used earlier in the treatment process, potentially improving outcomes for a broader range of patients.

The HSA’s decision is based on the interim analysis of the RUBY Phase III trial, a comprehensive study evaluating the efficacy of dostarlimab in combination with chemotherapy.

The results from Part 1 of the trial were particularly compelling, demonstrating a 72% reduction in the risk of disease progression or death in the dMMR/MSI-H population.

This significant reduction highlights Jemperli’s potential to transform cancer treatment, particularly for patients with limited effective treatment options.

Moreover, the RUBY trial met its primary endpoint of progression-free survival (PFS) and demonstrated a safety profile consistent with the known risks of the individual therapies involved.

This consistency further reinforces the viability of Jemperli as a critical component in the treatment regimen for endometrial cancer.

Commenting on this approval, GSK Singapore’s medical director, Dr. Stephanie Cinthu, emphasized that Singapore’s expanded regulatory approval of Jemperli redefines the treatment landscape for patients with dMMR/MSI-H primary advanced or recurrent endometrial cancer.

She highlighted that before this approval, chemotherapy alone was the standard of care, with many patients unfortunately experiencing disease progression.

She noted that the introduction of Jemperli in combination with chemotherapy offers a statistically significant and clinically meaningful benefit, potentially leading to better patient outcomes.

Dr. John Chia of Curie Oncology, Singapore, also weighed in on the importance of this approval, noting that metastatic endometrial cancer is an aggressive disease with historically poor outcomes.

According to Dr. Chia, the results of the RUBY trial represent a clinical breakthrough in the treatment of dMMR/MSI-H endometrial cancer, providing hope for potential complete remission when the treatment is administered early.

Jemperli was originally discovered by AnaptysBio and licensed to TESARO under an exclusive agreement signed in 2014.

Its potential has been further recognized globally, with the UK Medicines and Healthcare Products Regulatory Agency (MHRA) authorizing its use in October 2023 for treating adult patients with certain types of endometrial cancer.