FDA grants priority review to Tecentriq combination for non-small cell lung cancer
The FDA granted priority review to atezolizumab in combination with bevacizumab and chemotherapy for the fist-line treatment of patients with metastatic nonsquamous non-small cell lung cancer.
Atezolizumab (Tecentriq, Genentech) — a monoclonal antibody designed to bind with PD-L1 — already is approved for treatment of patients with metastatic NSCLC whose disease progressed during or after platinum-containing chemotherapy, as well as those whose disease progressed on an appropriate FDA-approved targeted therapy if their tumor has ALK or EGFR gene abnormalities. The agent also is approved for certain patients with urothelial carcinoma.
The FDA based the priority review designation on results of the phase 3 IMpower150 study, which included 1,202 patients with stage IV nonsquamous NSCLC who had not received chemotherapy for advanced disease.
The trial assessed the efficacy and safety of frontline atezolizumab in combination with paclitaxel and carboplatin with or without bevacizumab (Avastin, Genentech).
As HemOnc Today previously reported, IMpower150 met its coprimary endpoints of OS and PFS.
The safety profile of atezolizumab and bevacizumab plus chemotherapy appeared consistent with the known safety profile of each agent alone. Researchers observed no new safety signals with the combination.
“Our phase 3 results showed Tecentriq in combination with Avastin, paclitaxel and carboplatin has the potential to provide a significant survival benefit in the initial treatment of metastatic nonsquamous NSCLC,” Sandra Horning, MD, chief medical officer and head of global product development at Genentech, said in a company-issued press release. “We are working closely with the FDA to bring this treatment regimen to people with this type of lung cancer as soon as possible.”
The FDA set an action date of Sept. 5.