GSK’s Jemperli (dostarlimab) in combination with chemotherapy has been approved by the US Food and Drug Administration (FDA) for previously untreated, primary advanced or recurrent endometrial cancer.
The FDA’s decision, which specifically applies to patients whose tumours have mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) deficiency mutations, makes Jemperli the only immuno-oncology treatment approved in the frontline setting for this patient population.
The treatment regimen involves the drug plus standard of care chemotherapy (carboplatin-paclitaxel), followed by Jemperli as a single agent.
The anti-PD-1 therapy is already approved in the US as monotherapy in adult patients with dMMR recurrent or advanced endometrial cancer that has progressed on or following a prior platinum-containing regimen in any setting and are not candidates for curative surgery or radiation.
GSK’s supplemental biologics licence application supporting Jemperli’s latest indication is supported by positive results from the phase 3 RUBY trial, which demonstrated a 71% reduction in the risk of disease progression or death in dMMR and MSI-H patients receiving the combination.
The company outlined that the trial continues to assess overall survival in the intent-to-treat population, a dual-primary endpoint alongside investigator-assessed progression-free survival.
Endometrial cancer is one of the most common gynaecological cancers, with about 60,000 new cases of the disease diagnosed every year in the US.
Approximately 15% to 20% of patients with endometrial cancer will be diagnosed with advanced disease at the time of diagnosis, at which point treatment options are limited and prognosis is low.
Hesham Abdullah, senior vice president, global head of oncology development at GSK, said the expanded approval “redefines the treatment landscape for patients with dMMR/MSI-H primary advanced or recurrent endometrial cancer”.
US principal investigator of the RUBY trial, Matthew Powell, said: “As a clinician, I celebrate the practice-changing potential of adding Jemperli to chemotherapy for patients with dMMR/MSI-H primary advanced or recurrent endometrial cancer who have had limited treatment options.
“Based on the results from the RUBY clinical trial, I look forward to the addition of Jemperli to chemotherapy becoming a new standard of care for patients.”
Last month, GSK announced that the same patient population in the UK would be granted early access to the Jemperli (dostarlimab) combination via the Early Access to Medicines Scheme, which aims to give patients with life threatening or seriously debilitating conditions access to medicines that do not yet have a marketing authorisation.