Genentech announced that its Biologics License Application (BLA) for atezolizumab was granted priority review by the U.S. Food and Drug Administration (FDA) for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC), when the tumor expresses the protein PD-L1 and they have progressed on or after platinum-containing chemotherapy.
“In a study of atezolizumab in people with previously treated advanced lung cancer, PD-L1 expression correlated with how well they responded to the medicine,” Sandra Horning, M.D., Genentech’s chief medical officer and head of Global Product Development, said in a press release. “The goal of PD-L1 as a biomarker is to identify people most likely to benefit from atezolizumab alone.”
Atezolizumab, an anti-PDL1 checkpoint inhibitor, is an investigational monoclonal antibody engineered to bind with PD-L1, a protein called “programmed death ligand-1.” Atezolizumab was designed to bind directly to PD-L1 expressed on tumor cells and tumor-infiltrating immune cells, blocking their interactions with PD-1 and B7.1 receptors. By inhibiting PD-L1, the drug enables the activation of T-cells that will then infiltrate the tumor micro-environment and proceed toward its destruction.
In February 2015, atezolizumab was granted Breakthrough Therapy designation by the FDA for the treatment of patients whose NSCLC expressed PD-L1 and whose disease had progressed during or after standard chemotherapies (for instance, platinum-based or targeted for EGFR mutation-positive or ALK-positive disease).
A BTD designation is meant to accelerate the development and review of medicines that can treat serious life-threatening diseases while ensuring patients can access them as soon as possible. The BLA submission has similar conditions and is based on results from clinical trials, such as the Phase 2 BIRCH study, which evaluated the safety and efficacy of atezolizumab in 667 people with locally advanced or metastatic NSCLC that expressed PD-L1. Patients were given 1,200-mg IV dose of atezolizumab every three weeks, and the study met all its primary and secondary endpoints with positive results.
This is the second time the FDA granted Biologics License Application for atezolizumab. On March 14, Genentech announced the first BLA acceptance and Priority Review for the treatment of people with locally advanced or metastatic urothelial carcinoma (mUC). The therapeutic potential of atezolizumab is also being studied in several other cancers.