Atezolizumab Receives FDA Priority Review in NSCLC
Posted: Thursday, February 27, 2020
The U.S. Food and Drug Administration (FDA) granted Priority Review status for atezolizumab as a first-line monotherapy for patients with advanced nonsquamous and squamous non–small cell lung cancer without EGFR or ALK mutations with high PD-L1 expression. Atezolizumab is a monoclonal antibody designed to activate T cells by binding and inhibiting PD-L1. By binding PD-L1, this agent blocks the interaction with PD-1 and B7.1 receptors.
The Priority Review designation was based on the phase III, randomized, open-label IMpower110 trial, which studied the efficacy and safety of atezolizumab monotherapy in PD-L1–selected, chemotherapy-naive patients with advanced nonsquamous or squamous NSCLC without ALK or EGFR mutations. A total of 572 participants were randomly assigned 1:1 to receive atezolizumab, or cisplatin or carboplatin combined with either pemetrexed or gemcitabine followed by maintenance therapy with pemetrexed alone or best supportive care.
Monotherapy with atezolizumab alone showed improved overall survival by 7.1 months compared with chemotherapy (median overall survival = 20.2 vs. 13.1 months) in people with high PD-L1 expression. The safety profile of this agent remained consistent, with no new safety signals. About 12.9% of participants given atezolizumab reported grade 3 or 4 treatment-related adverse effects compared with 44.1% of participants receiving chemotherapy.
