Atezolizumab Receives Priority Review From the FDA in Early NSCLC
Posted: Friday, August 13, 2021
On August 3, the U.S. Food and Drug Administration (FDA) granted Priority Review to the monoclonal antibody atezolizumab for patients with non–small cell lung cancer (NSCLC). The review would appraise atezolizumab’s use as an adjuvant treatment following surgery and platinum-based chemotherapy for tumors expressing 1% or more of PD-L1, which would be determined by an FDA-approved test.
The FDA’s decision comes from the results observed in the global, multicenter, open-label phase III IMpower010 study. The clinical trial compared the efficacy and safety of atezolizumab with best supportive care in patients with stage IB–IIIA NSCLC after surgical resection and four cycles of adjuvant cisplatin-based chemotherapy. About 1,000 patients received up to 16 cycles of atezolizumab or best supportive care.
An interim analysis showed that atezolizumab treatment following surgery and platinum-based chemotherapy lowered the risk of disease recurrent or death by 34% compared with best supportive care. Currently, the primary endpoint of median disease-free survival had not yet been reached for atezolizumab compared with 35.3 months for best supportive care. The safety profile of atezolizumab was consistent with past studies, and the researchers did not observe any new safety signals.
Plans for a follow-up of the IMpower010 trial will involve a planned analysis of disease-free survival in the studied population and will also include patients with stage IB lung cancer. They will also measure overall survival, which had immature data at the time of interim analysis.
