GSK’s Jemperli (dostarlimab) has been recommended by the National Institute for Health and Care Excellence (NICE) in combination with platinum-containing chemotherapy as a first-line treatment for a subset of advanced endometrial cancer patients.
NICE’s final draft guidance specifically applies to adults with mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) deficiency primary advanced or recurrent endometrial cancer who are candidates for systemic therapy.
The agency’s decision comes around two years after Jemperli was made available in England via the Cancer Drugs Fund as monotherapy following platinum-based chemotherapy for patients with dMMR or MSI-H endometrial cancer.
Endometrial cancer, found in the inner lining of the uterus, is the most common gynaecological cancer in developed countries, with about 420,000 new cases reported globally in 2022.
Despite advances in medical science, outcomes for patients with advanced and recurrent endometrial cancer remain poor, with median overall survival reported to be less than three years with chemotherapy treatment alone.
There are approximately 2,770 people diagnosed with advanced or recurrent disease in England, Wales and Northern Ireland each year, and about 580 will now be eligible for treatment with Jemperli.
GSK’s application supporting the PD-1 inhibitor’s latest indication was supported by positive results from the late-stage RUBY trial, which demonstrated a more than 70% reduction in the risk of disease progression or death in dMMR and MSI-H patients receiving Jemperli plus carboplatin and paclitaxel relative to chemotherapy alone, as well as benefits in overall survival.
Jack Harris, vice-president UK oncology at GSK, said: “[NICE’s] decision is an important step forward, and a testament to our ongoing commitment to driving innovation for people with unmet needs, providing patients with the opportunity to access this treatment in the first-line treatment setting.”
The company said it will now be working with relevant health authorities across the UK to try to provide access for those who may benefit from the therapy in this first-line setting.
“NICE’s recommendation… enables access to the first major advance in decades for women with this disease with the potential to significantly improve their survival,” said Dr Rebecca Kristeleit, consultant medical oncologist at Guy’s and St Thomas’ NHS Foundation Trust and adjunct reader at King’s College London.
“This treatment option heralds a new era for biomarker-directed treatment of advanced endometrial cancer,” she added.