UNITED KINGDOM – UK health technology assessor the National Institute for Health and Care Excellence (NICE) has approved GlaxoSmithKline’s PD-1 inhibitor Jemperli for treating aggressive endometrial cancer.

Women in England with aggressive endometrial cancer will be able to receive immunotherapy for the first time, through the Cancer Drugs Fund (CDF).  

The health technology assessment (HTA) agency has approved the use of Jemperli (dostarlimab) for endometrial cancer patients with mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) mutations for the time being, while more evidence for the drug’s efficacy is gathered.

The drug was approved by the UK Medicines and Healthcare products Regulatory Agency (MHRA) in June 2021 for this type of cancer based on the findings of the GARNET trial, which included women who progressed on or after platinum-based chemotherapy.

In the study, Jemperli treatment resulted in a disease control rate of 57 percent – either complete response, partial response, or stabilized disease – with more than 90 percent of recipients still responding at 12 months.

Each year, approximately 7,700 new cases of endometrial cancer are diagnosed in the United Kingdom; approximately 170 of these women may be eligible for treatment with GSK’s antibody, which is also approved in the United States and the European Union.

The treatment works by blocking a receptor on T-cells called PD-1 (programmed death receptor-1) (a key part of the immune system). By doing so, it boosts the body’s immune system to continue attacking cancer cells.

GSK acquired Jemperli, the seventh approved drug in the PD-1/PD-L1 inhibitor class, as part of its US$5.1 billion acquisition of Tesaro, along with PARP inhibitor Zejula (niraparib), another drug facing stiff competition in the market.

It has yet to make much commercial progress, earning just £3 million (US$4 million) in the first nine months of 2021, despite the FDA expanding its label to include second-line treatment of all dMMR and MSI-H solid tumors last August.

The Tesaro deal was negotiated by GSK’s former R&D chief Hal Barron, who left the company last month to become CEO of well-funded US biotech startup Altos.

GSK is also conducting phase 3 trials of Jemperli as a first-line therapy for endometrial cancer, one as a monotherapy and the other in combination with Zejula, as well as a phase 2 trial in non-small cell lung cancer (NSCLC).

The company predicts that Jemperli will eventually become a blockbuster – it has a peak sales forecast of £1 (US$1.36 billion) to £2 billion (US$2.71 billion) for the drug, which some analysts believe is optimistic.

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