OSE Immunotherapeutics SA has announced the release of the abstract selected for an oral presentation at the upcoming ASCO 2026 annual meeting, unveiling topline results from the TEDOVA/GINECO-OV244b/ENGOT-ov58 academic, international, phase 2 trial evaluating Tedopi, with or without pembrolizumab, as a maintenance treatment in patients with platinum-sensitive recurrent ovarian cancer (PSOC).
Alexandra Leary, deputy head of the Department of Medical Oncology at Gustave Roussy (Paris, France), oncologist specialising in gynaecological cancers, chair of the GINECO group and lead investigator of the TEDOVA phase 2 clinical trial of Tedopi, said: “Ovarian cancer (OC) patients treated with platinum sensitive relapse post bevacizumab and PARP-inhibitors represent an unmet medical need with a progression free survival (PFS) of less than 3 months post platinum-based chemotherapy. In this difficult to treat setting, the combination of OSE2101 and pembrolizumab as maintenance significantly improved PFS. TEDOVA brings the first proof of concept for a vaccine strategy in OC, and actually the first positive trial in platinum sensitive OC in years.”
The TEDOVA phase 2 trial enrolled 185 patients with PSOC who have 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 (1:1:2) to receive maintenance treatment with either best supportive care (control arm A), Tedopi monotherapy (arm B), or Tedopi in combination with pembrolizumab (arm C). The primary endpoint was progression-free survival (PFS) comparing Arm C vs Arm A.
The primary endpoint was met, and results showed a statistically significant improvement in PFS for the combination of Tedopi and pembrolizumab compared to best supportive care. When comparing the two investigational arms, the addition of pembrolizumab to Tedopi resulted in a 28% reduction in the risk of progression or death.
The combination with pembrolizumab to Tedopi was associated with an increased incidence of adverse events, including immune-related events, consistent with the mechanism of action of immunotherapy.
The results will be presented on May 30 at the ASCO 2026 annual meeting in Chicago by Leary.
OSE will host a KOL webcast on June 10 to discuss how Tedopi could benefit patients affected by multiple oncology indications with key opinion leaders Stephen Liu (MedStar Georgetown University Hospital), Benjamin Besse (Gustave Roussy Institute, Paris), and Leary.
Marc Le Bozec, CEO, said: “Thanks to the collaboration with ARCAGY-GINECO, these results provide further clinical evidence supporting the potential of Tedopi in difficult-to-treat cancers such as ovarian cancer. 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.
“These findings reinforce our strategy to advance Tedopi in phase 3 development in non-small cell lung cancer, as well as in combination approaches through investigator-sponsored trials in ovarian, pancreatic, and lung cancers in collaboration with leading academic groups, with data expected through 2026.”