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OSE Immunotherapeutics Meets Primary Endpoint in Phase III Trial for HLA-A2 Positive Lung Cancer

NEW YORK – In Step 1 of the Phase III Atalante 1 trial, OSE Immunotherapeutics' investigational agent Tedopi improved the 12-month survival rate over chemotherapy in patients with HLA-A2 positive non-small cell lung cancer who failed PD-1 or PD-L1 immune checkpoint inhibitor therapy. 

The preliminary data show that in the Tedopi arm of the trial, the 12-month survival rate was 46 percent compared to 36 percent in the chemotherapy arm.

The Nantes, France-based company said that the next steps would be to further analyze the data in the Step 1 portion of the trial and discuss with regulatory agencies how to advance Tedopi through clinical development. The company is also interested in potential partnerships for developing Tedopi based on the preliminary Step 1 results.

Currently, there are no targeted therapies approved for the HLA-A2 positive NSCLC population. Tedopi has received orphan status in the US for HLA-A2 positive NSCLC patients, as well as personalized medicine status in HLA-A2 positive patients in Europe.

Tedopi is OSE's lead product candidate and is comprised of a combination of 10 neo-epitopes aimed at stimulating T-lymphocytes.

The company also noted that due to the COVID-19 pandemic it has suspended new patient accrual and canceled Step 2 of Atalante 1 that was initially planned. The company is among many other oncology trials that are experiencing disruptions in the midst of the coronavirus pandemic

Currently, Tedopi is also being evaluated in a Phase II trial in HLA-A2 positive pancreatic cancer patients in combination with checkpoint inhibitor nivolumab (Bristol Myers-Squibb's Opdivo). The study aims to evaluate the effects of Tedopi as a maintenance therapy, alone or in combination with nivolumab, compared to chemotherapy regimen Folfiri. The study will enroll HLA-A2 positive patients with stable disease who have previously undergone four months of standard chemotherapy with Folforinox, a combination chemotherapy with folinic acid, fluorouracil, irinotecan and oxaliplatin. 

OSE said they are continuing to screen patients for this Phase II trial but stated that GERCOR cooperative group in oncology, the study sponsor, has temporarily paused patient accrual.