Key Takeaways:
OSE Immunotherapeutics SA reported its cancer vaccine Tedopi (OSE2101), combined with pembrolizumab, reduced the risk of disease progression or death by 47% in a Phase 2 trial for recurrent ovarian cancer. The data positions the treatment as a potential new option for a patient group with high unmet medical need.
"TEDOVA brings the 1st proof of concept for a vaccine strategy in OC, and actually the 1st positive trial in platinum sensitive OC in years!” said Dr. Alexandra Leary, lead investigator of the TEDOVA trial and Chair of the GINECO group, in a statement.
The study showed the combination therapy extended median progression-free survival to 4.1 months, a significant improvement over the 2.8 months observed in the best supportive care arm. The results were statistically significant, with a hazard ratio of 0.53 and a p-value of less than 0.001, meaning there is a less than 0.1% chance the result is random.
These results, set for an oral presentation at the American Society of Clinical Oncology (ASCO) 2026 meeting on May 30, address a major unmet need for patients with platinum-sensitive ovarian cancer who have relapsed after treatment with PARP inhibitors and bevacizumab. This difficult-to-treat population currently has a progression-free survival of less than three months.
The international Phase 2 TEDOVA trial, sponsored by the French cooperative group ARCAGY-GINECO, enrolled 185 patients. After completing platinum-based therapy, participants were randomized to receive either best supportive care, Tedopi as a monotherapy, or Tedopi in combination with Merck's anti-PD-1 therapy pembrolizumab.
The primary endpoint was met, demonstrating the superiority of the Tedopi-pembrolizumab combination over best supportive care. The trial also highlighted the activity of Tedopi as a single agent. When comparing the two investigational arms, adding pembrolizumab to Tedopi resulted in a 28% reduction in the risk of progression or death.
The positive data reinforces OSE's strategy to develop Tedopi across multiple difficult-to-treat cancers. The company is advancing the vaccine into Phase 3 development for non-small cell lung cancer and supporting investigator-sponsored trials in pancreatic and other cancers, with more data expected through 2026.
"The data highlight both the clinical activity of Tedopi® as monotherapy and its strong synergy in combination with anti-PD-1 therapy in heavily pretreated patients," said Marc Le Bozec, Chief Executive Officer of OSE Immunotherapeutics. The company plans to host a webcast with key opinion leaders on June 10 to discuss the findings.
This article is for informational purposes only and does not constitute investment advice.
