GSK PLC said Friday that a Phase 3 trial for its Jemperli treatment for advanced or recurrent endometrial cancer met its primary endpoint, showing meaningful improvement in progression-free survival.
The pharmaceutical giant
said Jemperli was investigated together with standard-of-care chemotherapy. The trial also assessed the performance of Jemperli when compared to chemotherapy with a placebo, and a placebo, in patients with the cancer.
The trial showed a statistically significant and clinically meaningful improvement in investigator-assessed progression-free survival. The trial was the only first-line trial to show such an improvement for an immuno-oncology therapy combined with chemotherapy in endometrial cancer, GSK said.
While the overall survival data is immature at the time of analysis, a favorable trend was observed in the overall population. The safety and tolerability of Jemperli was consistent with clinical trials of similar regimens, the company said.
Regulatory submissions based on the trial results are expected in the first half of 2023.
The company separately said the European Medicines Agency has validated the marketing authorization application for momelotinib, its potential new oral treatment for myelofibrosis, based on results from key Phase 3 trials. A Committee for Medicinal Products for Human Use regulatory action is expected by the end of 2023.
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