French immuno-oncology firm OSE Pharma has started a Phase III trial (Atalante 1) of Tedopi, a potential treatment for patients with advanced non-small cell lung cancer (NSCLC).
The trial has been given approval by the company, as well as regulatory agencies and national ethics comittees in France, Italy and Czech Republic.
Patients are currently being enrolled, and the company is awaiting national authorisation from four European countries and the US.
OSE Pharma will start screening eligible HLA-A2 positive patients in the first investigational clinical sites. NSCLC patients will have failed a first line therapy, as provided in the study protocol.
OSE Pharma CEO Dominique Costantini said: "The initiation of the Phase III trial of Tedopi marks an important milestone of the product’s development, ‘Atalante 1’ being the pivotal study to support its registration in treatment of non-small cell lung cancer.
"We thank all investigational centres involved in the study who, together with our teams, are fully committed to conduct the major step of this development programme."
The trial is designed to evaluate the benefits of Tedopi compared to current standard chemotherapy docetaxel or pemetrexed, which are both approved in second line therapy.Its
Tedopi in second line or third line is administered in HLA-A2 positive patients diagnosed with stage IIIB or IV NSCLC.
Around 500 patients will be included in the Phase III trial, which will be conducted in 70 clinical sites in Europe and in the US.
The trial 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.