Phase III OAK study of Tecentriq (atezolizumab) shows improved overall survival in non-small cell lung cancer- Genentech/Roche

Genentech announced data from the positive, pivotal Phase III OAK study of Tecentriq (atezolizumab) which showed Tecentriq helped people live a median of 13.8 months, 4.2 months longer than those treated with docetaxel chemotherapy (median overall survival [OS]: 13.8 vs. 9.6 months; HR = 0.73, 95% CI: 0.62 - 0.87). The OAK study evaluated people with non-small cell lung cancer (NSCLC) whose disease had progressed on or after treatment with one or more platinum-based chemotherapy (second-line and third-line).

The study enrolled people regardless of their programmed death-ligand 1 (PD-L1) status and included both squamous and non-squamous disease types. Adverse events (AEs) were consistent with those observed in previous Tecentriq studies. Data were presented at the European Society of Medical Oncology (ESMO) 2016 Annual Meeting in Copenhagen, Denmark. Genentech has eight Phase III lung studies underway evaluating Tecentriq alone or in combination with other treatments in people with early and advanced stages of lung cancer.

Comment: The FDA granted Breakthrough Therapy Designation (BTD) for Tecentriq for the treatment of people with PD-L1-positive NSCLC whose disease has progressed during or after platinum-based chemotherapy (and appropriate targeted therapy for those with an EGFR mutation-positive or ALK-positive tumor). Genentech’s Biologics License Application (BLA) for NSCLC was granted Priority Review with an action date of Oct. 19, 2016.