GSK’s Jemperli (dostarlimab-gxly) has been approved by the US Food and Drug Administration (FDA) as part of a combination treatment for a broader range of endometrial cancer patients.
The regulator has authorised Jemperli for use alongside carboplatin and paclitaxel chemotherapy, then as a single agent, to treat all adults with primary advanced or recurrent endometrial cancer.
The approval expands the previous indication for Jemperli plus chemotherapy to include patients with mismatch repair proficient (MMRp)/microsatellite stable (MSS) tumours, who represent up to 75% of those diagnosed with the disease.
Endometrial cancer, found in the inner lining of the uterus, is the most common gynaecological cancer in developed countries, with about 417,000 new cases reported globally every year.
The FDA’s latest decision is supported by positive results from part one of the late-stage RUBY trial, which demonstrated a 31% reduction in risk of death in patients receiving the Jemperli combination compared to those treated with chemotherapy plus placebo followed by placebo.
A 16.4-month improvement in median overall was also observed with Jemperli plus chemotherapy versus chemotherapy alone.
“Jemperli plus chemotherapy is the first and only immuno-oncology regimen to show significant and meaningful improvement in overall survival (OS) for adult patients with primary advanced or recurrent endometrial cancer, regardless of biomarker status,” explained Hesham Abdullah, senior vice president, global head of oncology, research and development, GSK.
US principal investigator of the RUBY trial, Matthew Powell, Washington University School of Medicine, added: “The initial approval of Jemperli plus chemotherapy was practice-changing for patients with mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) primary advanced or recurrent endometrial cancer and [the] expanded approval will offer even more patients the opportunity for improved outcomes.”
The approval comes a few months after Jemperli was recommended by the National Institute for Health and Care Excellence in combination with platinum-containing chemotherapy as a first-line treatment for adults with dMMR/MSI-H primary advanced or recurrent endometrial cancer who are candidates for systemic therapy.
The agency’s decision in March was also based on results from RUBY, 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 OS.