OSE-2101 (Tedopi) met the primary endpoint in the predefined Step-1 analysis of the phase III Atalante 1 trial in patients with HLA-A2 positive non–small cell lung cancer (NSCLC) after failure of anti–PD-1/PD-L1 agents, according to OSE Immunotherapeutics, the manufacturer of the cancer vaccine.
“We are very pleased with these positive results for Tedopi in Step-1 and with a 10% absolute difference in 12-month survival rate versus chemotherapy in NSCLC patients after failure of checkpoint inhibitor treated in Atalante 1 Step-1 trial. This outcome confirms the therapeutic value of our neoepitope product in a patient population for whom there are no registered product today and who needs new therapeutic options. Based on these positive results, we are now eager to engage in discussions with regulatory authorities to evaluate Tedopi’s current clinical results and agree upon the best options for further development to maximize on the product’s positive data in terms of benefit/risk ratio. In parallel, given the significant value added by positive Step-1 results, we continue exploring potential partnership opportunities for Tedopi,” Alexis Peyroles, CEO of OSE Immunotherapeutics, said in the press release.
Phase 3 Clinical Trial of Tedopi®: OSE Immunotherapeutics Announces Positive Top-Line Results for Step-1 of its trial ‘Atalante 1’ in Non-Small Cell Lung Cancer. Published April 1, 2020. https://bit.ly/2JtRbLV. Accessed April 1, 2020.
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