OSE Immunotherapeutics and ARCAGY – GINECO Announce Initiation of a Randomized Phase 2 Clinical Trial Evaluating Tedopi® in Combination with Pembrolizumab in Ovarian Cancer

15 March 2021
  • This clinical trial will be sponsored and conducted by the French oncology cooperative group ARCAGY-GINECO and supported by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA, and OSE Immunotherapeutics.
  • The study will explore Tedopi®’s potential in an additional oncology indication with significant unmet medical need.

OSE Immunotherapeutics and the French cooperative group ARCAGY-GINECO today announced that the French National Agency for Medicines and Health Products Safety (ANSM) and the French Central Ethic Committee (CPP) approved the initiation of a new Phase 2 clinical trial evaluating Tedopi® in patients with recurrent ovarian cancer (the TEDOVA trial). Tedopi® will be evaluated alone and in combination with Merck’s Keytruda® (pembrolizumab), an immune checkpoint inhibitor, as maintenance treatment in ovarian cancer patients after chemotherapy.

The three arm TEDOVA study will evaluate neo-epitope-based vaccine Tedopi® as a maintenance treatment, alone or in combination with anti-PD-1 Keytruda®, versus the best supportive care in platinum-sensitive recurrent ovarian cancer patients with controlled disease after platinum-based chemotherapy.

The clinical trial is sponsored by the “Association de Recherche sur les CAncers dont GYnécologiques (ARCAGY-GINECO)” on behalf of GINECO, lead group for the TEDOVA trial of the European Network for Gynaecological Trial Groups (ENGOT). It will be supported in part by a research grant from the Investigator-Initiated Studies Program of MSD (Merck Sharp & Dohme Corp), a subsidiary of Merck & Co., Inc.”, which will provide Keytruda® (pembrolizumab), and by OSE Immunotherapeutics which will provide Tedopi® for the study as well as partial financial support.

Alexis Peyroles, Chief Executive Officer of OSE Immunotherapeutics, comments: “This new clinical development program for Tedopi® in ovarian cancer demonstrates the interest in exploring the potential of a PD-1-targeted checkpoint inhibitor combination strategy for combating oncology indications with significant unmet medical needs. We are very pleased to collaborate with the oncology group ARCAGY – GINECO to advance a new therapeutic pathway for patients suffering from a particularly aggressive cancer.”

Dr Alexandra Leary, Chief Investigator of TEDOVA study from Gustave Roussy cancer center, adds: “Our 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 selftolerance. TEDOVA is the first trial evaluating such an innovative approach in ovarian cancer and has received enthusiastic support from the international gynecological oncology community.”