OSE Immunotherapeutics and ARCAGY-GINECO Announce First Patient Randomized in Phase 2 Clinical Trial Evaluating Tedopi® in Combination with Pembrolizumab in Ovarian Cancer

27 August 2021

  • Clinical trial sponsored and conducted by the French oncology cooperative group ARCAGY-GINECO and supported by Merck Sharp & Dohme Corp. (MSD), a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA, known as MSD outside of the US and Canada, and OSE Immunotherapeutics.
  • Innovative approach in ovarian cancer, an oncology indication with high unmet medical need.
  • First Results expected beginning of 2025.

OSE Immunotherapeutics  and the French cooperative group ARCAGY-GINECO announced today that the first patient has been randomized in the Phase 2 clinical trial evaluating Tedopi® alone and in combination with MSD’s Keytruda® (pembrolizumab) as maintenance treatment in patients with recurrent ovarian cancer after chemotherapy (the TEDOVA trial).

The three arm TEDOVA study aims at evaluating the neo-epitope-based vaccine Tedopi® as a maintenance treatment, alone or in combination with anti-PD-1 immune checkpoint inhibitor
Keytruda®, versus best supportive care in patients with first or second platinum-sensitive recurrent ovarian cancer with controlled disease after platinum-based chemotherapy and who have already received both bevacizumab and a PARP (Poly ADP-Ribose Polymerase) inhibitor.

Dr Alexandra Leary, Chief Investigator of TEDOVA study from Gustave Roussy cancer center, comments: “We are very pleased to announce enrolment of the first patient in TEDOVA, the first trial evaluating an innovative maintenance strategy for patients in first or second platinum sensitive relapse post-PARP inhibitor and bevacizumab. We look forward to evaluating this therapeutic option for women with ovarian cancer and a strong unmet medical need ”.

Patients with ovarian cancer do not respond to checkpoint inhibitors (ICI) alone because these tumors are ‘immune cold’. The objective of TEDOVA is to turn ovarian cancer into an ‘immune hot’ tumor using a combination of tumor associated neo-epitopes that have been optimized to break immunological self-tolerance.

This Phase 2 trial, sponsored by the “Association de Recherche sur les CAncers dont GYnécologiques (ARCAGY-GINECO)” on behalf of GINECO, is designed to enroll 180 patients and will be conducted at approximately 30 sites in France and around 12 sites in Germany and Belgium.

Alexis Peyroles, Chief Executive Officer of OSE Immunotherapeutics, adds: “Having the first patient enrolled by our oncology group partner marks a significant milestone in Tedopi®’s development by exploring its impact in an additional oncology indication. We are expecting first results on the potential of such an innovative PD-1 targeted checkpoint combination strategy at the beginning of 2025”.

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