On August 26, 2021 OSE Immunotherapeutics and the French cooperative group ARCAGY-GINECO reported 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) (Press release, OSE Immunotherapeutics, AUG 26, 2021, View Source [SID1234646975]).

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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".

ABOUT OVARIAN CANCER
Worldwide, ovarian cancer is the seventh most common cancer and the eighth leading cause of cancer death in women. The five-year survival rate for ovarian cancer worldwide is 30-40%. In 2018, there were nearly 300,000 new cases diagnosed. Once the first relapse has occurred, ovarian cancer is managed as a chronic disease, requiring iterative lines of platinum-based chemotherapy. After 6 cycles, chemotherapy is stopped and one of the major priorities is to extend "chemotherapy-free" intervals for the patients by proposing maintenance strategies with targeted therapies (PARP inhibitors or bevacizumab). By the time patients with ovarian cancer present with first or second relapse, they will have received BOTH a PARP inhibitor and bevacizumab, thus patients progressing post-PARP inhibitors and bevacizumab represent an area of unmet medical need, they are offered chemotherapy alone with no maintenance strategy. The TEDOVA trial focuses on these women