2023-04-27 08:40:00
The European Medicines Agency (EMA) has accepted an application for a potential new indication for the immunotherapy dostarlimab, in combination with chemotherapy, for the treatment of adult patients with advanced or recurrent primary endometrial cancer with a genetic condition known as mismatch repair deficiency (dMMR)/MSI-H, high level of microsatellite instability).
The request – the British pharmaceutical group GSK explains in a note – is based on the intermediate results of the phase 3 Ruby study (RUBY/ENGOT-EN6/GOG3031/NSGO), which met the primary endpoint of progression-free survival (Pfs ) showing a statistically and clinically significant benefit compared to placebo plus standard chemotherapy (carboplatin-paclitaxel) in patients treated with dostarlimab plus chemotherapy in the dMMR/MSI-H population. Specifically, there was a 72% and 36% reduction in the risk of disease progression or death in the dMMR/MSI-H population and overall patient population, respectively. Additionally, the safety and tolerability profile of dostarlimab, a monoclonal antibody, in combination with carboplatin-paclitaxel was generally consistent with the known safety profiles of the individual agents.
The results were presented on March 27 at the virtual plenary meeting of the European Society of Medical Oncology and at the annual congress of the American Society of Gynecological Oncology, and simultaneously published in the ‘New England Journal of Medicine’. EMA’s Committee for Medicinal Products for Human Use (CHMP) will initiate the formal review process in order to make a recommendation to the European Commission regarding the marketing authorization of this potential new indication.
“New treatment options are needed for patients with advanced or recurrent primary endometrial cancer,” said Hesham Abdullah, Senior Vice President, Global Head of Oncology Development, GSK. “With this submission, we are accelerating the rollout of a potential new indication for dostarlimab in the population. of patients who demonstrated the strongest treatment effect in the Phase 3 Ruby study.These patients currently face significant unmet medical needs, and this combination could change the treatment paradigm for this condition.The Phase 3 Ruby study continues in patients for the dual primary endpoint of overall survival in the intent-to-treat population”.
GSK, the company underlines in the note, expects approval in the United States by June.
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