OSE Pharma SA, an immunooncology company developing a T-specific immunotherapy for late-stage cancerpatients, has announced the initiation of its registration clinical trial named "Atalante 1". This trial evaluates Tedopi®, the company's lead product for advanced non-small cell lung cancer (NSCLC).
The formal authorizations from regulatory agencies in France, Italy and Czech Republic, and the positive opinions from national ethic committees in these three countries enable the initiation of the Phase 3 trial Atalante 1. Patient enrollment is now open in these three countries and the company is expecting the same national authorizations in the remaining four European countries and in the US. Screening of eligible HLA-A2 positive patients begins in the first investigational clinical sites in NSCLC patients after failure of at least a first line therapy, as provided in the study protocol.
"The initiation of the Phase 3 trial of Tedopi® marks an important milestone of the product's development, "Atalante 1" being the pivotal study to supportits registration in treatment of non-small cell lung cancer. We warmly thank all investigational centers involved in the study who, together with our teams, are fully committed to conduct the major step of this development program", commented Dominique Costantini, CEO of OSE Pharma.
This trial aims at evaluating the benefits of Tedopi® as compared to current standard chemotherapy (docetaxel or pemetrexed, both approved in second linetherapy). Tedopi®is administered in second line or third line in HLA-A2 positive patients diagnosed with stage IIIB (locally advanced) or IV (metastatic) non-small cell lung cancer (NSCLC). The primary endpoint of this trial is overall survival. The phase 3 trial is conducted in 70 investigational clinical sites in Europe and in the US and will include 500 patients. It is expected to be completed in 2018 provided that the recruitment of patients, their observed survival and the safety of the product meet the strict criteria set for this trial.