Genentech announced that in the large pivotal Phase 2 study, BIRCH, atezolizumab (MPDL3280A; anti-PDL1) met its primary endpoint and shrank tumors (objective response rate; ORR) in people with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease expressed PD-L1 (Programmed Death Ligand-1).

BIRCH is an open-label, multicenter, single-arm Phase 2 study that evaluated the safety and efficacy of atezolizumab in 667 people with locally advanced or metastatic NSCLC whose disease expressed PD-L1. The primary endpoint of the study was ORR. The study showed the amount of PD-L1 expressed by a person’s cancer correlated with their response to the drug.

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The Food and Drug Administration (FDA) granted atezolizumab Breakthrough Therapy designation earlier this year for the treatment of people whose NSCLC expresses PD-L1 and who progressed during or after standard treatments (e.g., platinum-based chemotherapy and appropriate targeted therapy for EGFR mutation-positive or ALK-positive disease).

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