OSE Pharma Receives FDA And EMA Approval To Begin NSCLC Phase 3 Trial
OSE Pharma announced that it has received positive feedback from both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), and that it will now be allowed to start a Phase III clinical trial for its OSE-2101 in non-small cell lung cancer (NSCLC).
The FDA provided positive feedback during a Phase II/pre-Phase III meeting while the EMA gave the company positive Scientific Advice to begin Phase III development. The company said the trial will enroll 500 patients with advanced stage IIIb invasive or metastatic stage IV NSCLC patients who express the HLA-A2 receptor (45% of the NSCLC population). The Phase III study will investigate OSE-2101 compared to docetaxel or pemetrexed, two chemotherapeutic agents which have been approved as second line treatments in the patient population. Primary and secondary endpoint of the trial will be overall survival (OS) and progression free survival (PFS), respectively.
OSE-2101 is a multi-epitope therapeutic cancer vaccine intended for the treatment of advanced NSCLC (non-small cell lung cancer) in HLA-A2 positive patients who have failed to respond positively to primary treatment. The vaccine has been considered an orphan drug by the FDA since February 2013 for the treatment of NSCLC in patients with the HLA-A2 receptor.
Emile Loria, Chairman of OSE Pharma, said, “I am glad about this simultaneous positive response from both agencies, the FDA and the EMA, for the pivotal Phase 3 with OSE-2101 in a severe cancer patient population. We now have a clear plan for advancing what we believe is an exciting new cancer immunotherapy. Given my personal involvement in the development of OSE-2101, I am confident that this multi-epitope therapeutic vaccine will provide important benefits to patients with cancers.”
Dominique Costantini, CEO of OSE Pharma, said, “We are actively preparing for the start of the OSE-2101 Phase 3 study both in terms of the clinical trial logistics and the manufacturing of the product needed to conduct this trial planned to begin in the first semester of 2015.” A total of 500 patients are expected to be recruited across the U.S. and EU for the Phase III trial of OSE-2101.