A late-stage lung cancer drug under development by OSE Immunotherapeutics met its 12-month primary endpoint for survival rates following a Step-1 analysis.
A late-stage lung cancer drug under development by OSE Immunotherapeutics met its 12-month primary endpoint for survival rates following a Step-1 analysis. But, the ongoing COVID-19 pandemic is causing the company to rethink its ongoing clinical plans for the drug.
On Wednesday, France-based OSE said its investigational drug Tedopi hit the mark in the Phase III analysis in HLA-A2 positive non-small cell lung cancer (NSCLC) patients after failure from immune checkpoint inhibitors (PD-1/PD-L1). Tedopi, is a proprietary combination of 10 neo-epitopes aimed at stimulating T-lymphocytes. In the Phase III Atalante-1 Step-1 analysis, the statistically positive preliminary results show at least 12-month survival for 29 patients out of 63 patients in the Tedopi arm, corresponding to a 12-month survival rate of 46%, the company announced. The observed rate of 46% is also above the assumption of a survival rate of 40% specified for the alternative efficacy hypothesis in the protocol, the company added. In the chemotherapy control arm, the results show at least 12-month survival for 13 patients out of 36 patients, corresponding to a 12-month survival rate of 36%.
OSE Immunotherapeutics Chief Executive Officer Alexis Peyroles said the company is pleased with the late-stage data for Tedopi, particularly the 1o% difference in the one-year survival rate versus chemotherapy.
“This outcome confirms the therapeutic value of our neoepitope product in a patient population for whom there are no registered products 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,” Peyroles said in a statement.
OSE sees significant value in Tedopi, which has been buoyed by the Step-1 results. Peyroles said the company Tedopi is also being studied in a Phase II trial in pancreatic cancer in combination with Bristol Myers Squibb’s checkpoint inhibitor Opdivo. is exploring potential partnership options for the asset.
While the Step-1 analysis has been complete, OSE said the ongoing COVID-19 pandemic could impact the study. As of today, there is ongoing concern that trial data may be markedly impacted given the current worldwide COVID-19 pandemic and the increased risk for patients with NSCLC as COVID-19 can cause serious pulmonary complications in this immunocompromised patient population, the company said. Following the recommendation from both the Independent Data Monitoring Committee and Steering Committee for Atalante 1, OSE Immunotherapeutics voluntarily decided to terminate patient screening and accrual in the initially planned and now canceled Step-2, the company said.
“Further analysis of the positive Step-1 data will commence while engaging with regulatory agencies on the best development path forward for the product given the significant unmet medical need in the NSCLC patient population post-checkpoint inhibitor therapy failure,” OSE said in its statement.
