The FDA recently announced the approval of the monoclonal antibody, atezolizumab (Tecentriq, Genentech, Inc.) for adjuvant treatment following resection and platinum-based chemotherapy in patients with stage II to IIIA non-small cell lung cancer (NSCLC) whose tumors have PD-L1 expression on ≥1% of tumor cells, as determined by an FDA-approved test.

This approval makes atezolizumab the first and only cancer immunotherapy approved for the treatment of NSCLC in the adjuvant setting. The FDA also approved the VENTANA PD-L1 (SP263) Assay (Ventana Medical Systems, Inc.) as a companion diagnostic device to select patients with NSCLC for adjuvant treatment with atezolizumab. (In August 2021, the FDA granted Priority Review for atezolizumab.)

The approval is based on results from an interim analysis of the phase III IMpower010 study that showed treatment with atezolizumab following surgery and platinum-based chemotherapy reduced the risk of disease recurrence or death by 34% (hazard ratio [HR] = 0.66, 95% CI: 0.50-0.88) in individuals with Stage II-IIIA (UICC/AJCC 7th edition) NSCLC whose tumors express PD-L1≥1%, compared with best supportive care (BSC).

The study randomized 1,005 people with a ratio of 1:1 to receive either atezolizumab for 1 year (16 cycles), unless disease recurrence or unacceptable toxicity occurred, or BSC. The primary endpoint was investigator-determined DFS in the PD-L1-positive Stage II-IIIA, all randomized Stage II-IIIA, and intent-to-treat (ITT) Stage IB-IIIA populations. Key secondary endpoints included overall survival (OS) in the overall study population, ITT Stage IB-IIIA NSCLC.

The recommended atezolizumab dose for this indication is 840 mg every 2 weeks, 1,200 mg every 3 weeks, or 1,680 mg every 4 weeks for up to 1 year. Safety data for atezolizumab was consistent with its known safety profile, and no new safety signals were identified. Fatal and serious adverse reactions occurred in 1.8% and 18%, respectively, of patients receiving atezolizumab. The most frequent serious adverse reactions (>1%) were pneumonia (1.8%), pneumonitis (1.6%), and pyrexia (1.2%).

Levi Garraway, MD, PhD, Genentech's chief medical officer and head of Global Product Development, stated, "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. 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."

Atezolizumab previously demonstrated clinically meaningful benefit in various types of lung cancer, with six currently approved indications in the United States. In addition to becoming the first approved cancer immunotherapy for adjuvant NSCLC, this agent was also the first approved cancer immunotherapy for front-line treatment of adults with extensive-stage SCLC in combination with carboplatin and etoposide. Atezolizumab also has four approved indications in advanced NSCLC as either a single agent or in combination with targeted therapies and/or chemotherapies and is available in three dosing options, providing the flexibility to choose administration every 2, 3, or 4 weeks.

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