FDA Accepts sBLA, Grants Priority Review to Atezolizumab for Initial Treatment of Metastatic Nonsquamous NSCLC
The U.S. Food and Drug Administration (FDA) recently accepted a supplemental biologics license application (sBLA) and granted Priority Review for atezolizumab (Tecentriq) in combination with bevacizumab (Avastin), paclitaxel, and carboplatin for the first-line treatment of metastatic nonsquamous non–small cell lung cancer (NSCLC). The FDA is expected to make a decision on approval by September 5, 2018.
“Our phase III results showed atezolizumab in combination with bevacizumab, paclitaxel, and carboplatin has the potential to provide a significant survival benefit in the initial treatment of metastatic nonsquamous non–small cell lung cancer,” said Sandra Horning, MD, Chief Medical Officer and Head of Global Product Development at Genentech.
This sBLA is based on results from the phase III IMpower150 study, which met its coprimary endpoints of overall survival and progression-free survival in the initial treatment of patients with advanced nonsquamous NSCLC. The safety profile of the combination was consistent with the safety profiles of the individual medicines, and no new safety signals were identified.
Atezolizumab is currently approved by the FDA to treat patients with metastatic NSCLC who have disease progression during or following platinum-containing chemotherapy and after an appropriate FDA-approved targeted therapy if their tumor has ALK or EGFR gene abnormalities.
More About the IMpower150 Study
IMpower150 is a multicenter, open-label, randomized, controlled phase III study evaluating the efficacy and safety of atezolizumab in combination with carboplatin and paclitaxel with or without bevacizumab in people with stage IV nonsquamous NSCLC who had not been treated with chemotherapy for their advanced disease. It enrolled 1,202 people, of which those with ALK and EGFR mutations were excluded from the primary intention-to-treat analysis. People were randomized (1:1:1) to receive:
- Atezolizumab plus carboplatin and paclitaxel, or
- Atezolizumab and bevacizumab plus carboplatin and paclitaxel, or
- Bevacizumab plus carboplatin and paclitaxel (control arm).
The coprimary endpoints were overall and progression-free survival, as determined by the investigator using Response Evaluation Criteria in Solid Tumors Version (RECIST), version 1.1. The primary analysis of the coprimary progression-free survival endpoint in IMpower150 was assessed in two populations: all randomized people without an ALK or EGFR genetic mutation (intention-to-treat wild-type) and in a subgroup of people who had a specific biomarker (effector T-cell [Teff] gene signature expression).
The coprimary overall survival endpoint was assessed in all randomized people without an ALK or EGFR genetic mutation (intention-to-treat wild-type). Key secondary endpoints included investigator-assessed progression-free and overall survival, and safety in the intention-to-treat population and in EGFR and ALK mutation subgroups.
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