French biotechnology company OSE Immunotherapeutics SA (Euronext Paris:OSE) on Friday reported positive topline results from the Phase 2 TEDOVA trial evaluating Tedopi, with or without pembrolizumab, as maintenance therapy for platinum-sensitive recurrent ovarian cancer.
The international study enrolled 185 people who had progressed after or were ineligible for PARP inhibitors and bevacizumab. Patients with complete response, partial response, or stable disease after platinum-based therapy were randomised to receive maintenance treatment with best supportive care, Tedopi monotherapy, or Tedopi combined with pembrolizumab.
The trial achieved its primary endpoint, demonstrating a statistically significant improvement in progression-free survival for the Tedopi and pembrolizumab combination compared with best supportive care, with median progression-free survival of 4.1 months versus 2.8 months, respectively. Comparing the two investigational arms, the addition of pembrolizumab to Tedopi resulted in a 28% reduction in the risk of progression or death.
OSE said the combination therapy was associated with a higher incidence of adverse events, including immune-related events, consistent with immunotherapy mechanisms.
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