FDA Approves Atezolizumab as Adjuvant Treatment in Certain Patients With NSCLC
Officials with the FDA have approved atezolizumab (Tecentriq, Genentech) as adjuvant treatment following surgery and platinum-based chemotherapy for adults with stage II-III A non-small cell lung cancer (NSCLC) whose tumors express programmed death-ligand 1 (PD-L1) ≥1% as determined by an FDA-approved test. According to Genentech, atezolizumab is the first and only cancer immunotherapy approved for adjuvant treatment of NSCLC.
“Too many patients with early-stage lung cancer experience disease recurrence following surgery,” said Bonnie Addario, co-founder and chair of the GO2 Foundation for Lung Cancer, in a press release. “Now, the availability of immunotherapy following surgery and chemotherapy offers many patients new hope and a powerful new tool to reduce their risk of cancer relapse. With this approval, it is more important than ever to screen for lung cancer early and test for PD-L1 at diagnosis to help bring this advance to the people who can benefit.”
The approval is based on the interim analysis of the phase 3 IMpower010 study, which demonstrated treatment with atezolizumab following surgery and platinum-based chemotherapy reduced the risk of disease recurrence or death by 34% for patients with stage II-IIIA NSCLC whose tumors express PD-L1 ≥1% compared to best supportive care (BSC) alone. Safety data for the drug were consistent with its known safety profile and no new safety signals were identified, with fatal adverse events (AEs) occurring in 1.8% of patients and serious AEs occurring in 18% of patients.
“Tecentriq is now the first and only cancer immunotherapy available for adjuvant treatment of NSCLC, introducing a new era where people diagnosed with early lung cancer may have the opportunity to receive immunotherapy to increase their chances for cure,” said Levi Garraway, MD, PhD, chief medical officer and head of Global Product Development at Genentech, in the release. “Today’s landmark approval gives physicians and patients a new way to treat early lung cancer that has the potential to significantly reduce risk of cancer recurrence, after more than a decade with limited treatment advances in this setting.”
IMpower010 is a global, multicenter, open-label, randomized study evaluating the efficacy and safety of atezolizumab compared with BSC. The investigators randomized 1005 individuals 1:1 to receive either 1 year of atezolizumab, barring disease recurrence or excessive toxicity, or BSC.
Atezolizumab is a monoclonal antibody designed to bind with PD-L1 expressed on tumor cells and tumor-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. According to Genentech, atezolizumab has previously demonstrated clinically meaningful benefit in various types of lung cancer, with 6 approved indications in the United States.
FDA approves Genentech’s Tecentriq as adjuvant treatment for certain people with early non-small cell lung cancer [news release]. Genentech; October 15, 2021. Accessed October 18, 2021. https://www.gene.com/media/press-releases/14934/2021-10-15/fda-approves-genentechs-tecentriq-as-adj