FDA Approves Atezolizumab to Treat Select NSCLC in Adjuvant Setting


Atezolizumab is the first immunotherapy approved in the adjuvant setting to treat NSCLC.

The FDA has approved atezolizumab (Tecentriq) as an adjuvant therapy to treat adults with stage II to IIA non-small-cell lung cancer (NSCLC) whose tumors harbor PD-L1, as demonstrated by an FDA-approved test, following resection and platinum-based chemotherapy, according to a press release by Roche.

The regulatory decision was informed by findings from an interim analysis of the phase 3 Impower010 study. Results demonstrated that atezolizumab therapy following surgery and platinum-based chemotherapy decreased the risk of disease recurrence or death by 34% (HR, 0.66; 95% CI, 0.50-0.88) among patients with advanced NSCLC and tumors with PD-L1 expression.

"[Atezolizumab] 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,” Levi Garraway, MD, PhD, chief medical officer and head of global product development at Roche, stated in a press 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.”

No new safety signals were detected. Among patients receiving atezolizumab, 1.8% experienced fatal adverse events (AEs) and 18% reported serious grade AEs. The most common AEs included pneumonia (1.8%), pneumonitis (1.6%), and pyrexia (1.2%). However, other toxicities included increased aspartate aminotransferase, blood creatinine, and alanine aminotransferase, as well as hyperkalemia, rash, cough, hypothyroidism, pyrexia, fatigue/asthenia, musculoskeletal pain, peripheral neuropathy, arthralgia, and pruritus.2

“Too many patients with early-stage lung cancer experience disease recurrence following surgery. 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,” said Bonnie Addario, GO2 Foundation for Lung Cancer, sin the press release. “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.

Notably, atezolizumab is also approved for genitourinary, skin, breast, gastrointestinal, gynecologic, and head and neck cancers. It is currently being evaluated as a monotherapy and in combination with other medicines across multiple different settings in solid tumors.


  1. US FDA approves Roche's Tecentriq as adjuvant treatment for certain people with early non-small cell lung cancer. News release. Roche. October 15, 2021. Accessed October 15, 2021. https://bit.ly/3BMUGXy
  2. Wakelee HA, Altorki NK, Zhou C, et al. IMpower010: primary results of a phase III global study of atezolizumab versus best supportive care after adjuvant chemotherapy in resected stage IB-IIIA non-small cell lung cancer (NSCLC). J Clin Oncol. 2021;39(suppl 15):8500. doi:10.1200/JCO.2021.39.15_suppl.8500

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