The Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for atezolizumab (Tecentriq®) as adjuvant treatment following surgery and platinum-based chemotherapy for patients with non-small cell lung cancer (NSCLC) whose tumors express PD-L1 of at least 1%, as determined by an FDA-approved test.
The sBLA is supported by data from the global, multicenter, open-label, randomized phase 3 IMpower010 study (ClinicalTrials.gov Identifier: NCT02486718) that compared the efficacy and safety of atezolizumab with best supportive care (BSC) in 1005 adults with Stage IB-IIIA NSCLC after resection and adjuvant chemotherapy. Patients were randomly assigned 1:1 to receive either atezolizumab 1200mg intravenously (IV) every 3 weeks for up to 16 cycles or BSC.
Findings showed that among patients with Stage II-IIIA NSCLC whose tumors expressed PD-L1 of at least 1%, treatment with atezolizumab reduced the risk of disease recurrence or death by 34% compared with BSC (hazard ratio [HR], 0.66; 95% CI, 0.50-0.88). In this patient population, median disease-free survival (DFS) was not yet reached in the atezolizumab treatment arm compared with 35.3 months for the BSC arm. Analyses of DFS in the overall ITT population (including Stage IB patients) and OS data were immature at the time of interim analysis. No new safety signals were identified in the study.
“New treatment options are urgently needed in early-stage non-small cell lung cancer to help the nearly 50% of people who currently experience a recurrence following surgery,” said Levi Garraway, MD, PhD, chief medical officer and head of Global Product Development. “Tecentriq is the first cancer immunotherapy to show a clinically meaningful benefit in the adjuvant lung cancer setting, and we’re working closely with the FDA to bring this significant advancement to patients as quickly as possible.”
The FDA is expected to make a decision on approval by December 1, 2021.
FDA grants Priority Review to Genentech’s Tecentriq as adjuvant treatment for certain people with early non-small cell lung cancer. News release. Genentech. Accessed August 4, 2021. https://www.businesswire.com/news/home/20210802005854/en/FDA-Grants-Priority-Review-to-Genentech%E2%80%99s-Tecentriq-as-Adjuvant-Treatment-for-Certain-People-With-Early-Non-small-Cell-Lung-Cancer.