OSE Immunotherapeutics Presented Positive Final Results of Tedopi Phase 3 Clinical Trial in Secondary Resistant Non-Small Cell Lung Cancer Patients at the European Society for Medical Oncology (ESMO) Virtual Congress 2021

Results show statistical improvement in overall survival, favorable benefit/risk ratio and better quality of life in NSCLC patients after secondary resistance to checkpoint inhibitors

NANTES, France, Sept. 20, 2021 (GLOBE NEWSWIRE) -- OSE Immunotherapeutics (ISIN: FR0012127173; Mnémo: OSE) today announced that the positive final results of its Phase 3 trial of neoepitope-based cancer vaccine Tedopi, called Atalante 1, in HLA-A2 positive patients with advanced non-small cell lung cancer (NSCLC) after immune checkpoint inhibitor (PD-1/PD-L1) failure, were presented in a late-breaking oral presentation⁽¹⁾ at the European Society for Medical Oncology (ESMO) Virtual Congress being held on September 16 – 21, 2021.

Pr. Benjamin Besse, Director of Clinical Research at Gustave Roussy (Villejuif, France), and Principal Investigator of the Atalante 1 study, commented: “There was a lot learned during this trial about Tedopi and its potential clinical benefit that will help inform future studies in the immunotherapy field. Applying the 2020 SITC⁽²⁾ guidelines defining resistance categories for PD-1/PD-L1 checkpoint inhibitors to our trial, developed while this trial was ongoing, suggest there is great potential for Tedopi in patients with secondary resistance⁽³⁾. Therefore, we are very pleased to share such very promising results demonstrating the substantial benefits of Tedopi for NSCLC patients with secondary resistance to anti-PD-1 treatments, a hard to treat patient population with high medical need.”

The Atalante 1 clinical trial evaluated the benefit of Tedopi in an HLA-A2 positive patient population with NSCLC at invasive stage IIIB or metastatic stage IV, in 2^nd or 3^rd line treatment following checkpoint inhibitor failure. The Tedopi treatment was compared to docetaxel or pemetrexed chemotherapy (CT) treatments in this patient population, with overall survival as the primary endpoint of the trial.

Positive Phase 3 step-1 results, presented at ESMO 2020⁽⁴⁾, identified a Population of Interest (PoI) of secondary resistance defined as failure after a minimum of 12 weeks after immune checkpoint inhibitor treatment sequential to platinum-based chemotherapy. This PoI was chosen as the primary population for the final analysis.

A total of 219 patients were enrolled in Atalante 1. 183 (84%) of these patients received sequential CT-immunotherapy (IO), of which 118 patients (54%) met the definition of PoI, with otherwise similar other baseline characteristics to the overall Atalante 1 population.