Lung Cancer Drug Extends Overall Survival in Phase 3 Trial

A phase 3 study of atezolizumab (Tecentriq) met its co-primary endpoints, showing significant improvement in overall survival for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC).

Tecentriq is a monoclonal antibody designed to bind to the protein PD-L1, which is expressed on tumor cells (TC) and tumor-infiltrating (IC) immune cells, blocking its interactions with body PD-1 and B7.1 receptor.

The findings were based on the open-label, controlled, global, multicenter, randomized phase 3 study OAK, which evaluated the safety and efficacy of Tecentriq, compared with docetaxel in people with local advanced or metastatic NSCLC whose disease progressed on or after treatment with platinum-containing chemotherapy.

Researchers enrolled 1225 patients randomized 1:1 to receive either docetaxel (75-mg/m² intravenous infusion) or Tecentriq (1200-mg intravenous infusion) every 3 weeks. Treatment on Tecentriq continued as long as patients experienced clinical benefit, as assessed by investigator or until unacceptable toxicity. The study’s co-primary endpoints were overall survival in all individuals randomized to treatment in the study (intention-to-treat or ITT population), and a PD-L1 selected subgroup of patients.

The PD-L1 expression was assessed on both TC and IC with an investigational immunohistochemistry (IHC) test based on the SP142 antibody currently developed by Roche Tissue Diagnostics, and was defined as individuals whose tumors were determined to express PD-L1 with an IHC score of TC1/2/3 or IC1/2/3.

The results of the OAK study met its co-primary endpoints, showing a statistically significant and clinically meaningful improvement in overall survival compared with docetaxel chemotherapy in people with locally advanced or metastatic NSCLC, whose disease progressed on or after treatment with platinum-based chemotherapy. Adverse events were consistent with those previously observed in Tecentriq treatment.

“These results add to the growing body of evidence that supports the role to Tecentriq as a potential new treatment for specific types of advanced NSCLC,” said Sandra Horning, MD, chief medical officer and head of Global Product Development. “This is very encouraging news for people living with this disease because lung cancer is the leading cause of cancer deaths around the world. We hope to bring this treatment option to patient as soon as possible.”

The FDA granted Breakthrough Therapy Designation for Tecentriq for the treatment of people with PD-L1 positive NSCLC, whose disease progressed during or after platinum-based chemotherapy. Genentech’s Biologics License Application for NSCLC was granted Priority Review with an action date of October 19, 2016.

The full results of the study will be presented by Genentech at an upcoming meeting in 2016.