The Food and Drug Administration (FDA) has approved Tecentriq (atezolizumab) for adjuvant treatment following resection and platinum-based chemotherapy for adult patients with stage II to IIIA non-small cell lung cancer (NSCLC) whose tumors express PD-L1 expression on at least 1% of tumor cells, as determined by an FDA-approved test.
The approval was based on data from the global, multicenter, open-label, randomized phase 3 IMpower010 study (ClinicalTrials.gov Identifier: NCT02486718), which compared the efficacy and safety of atezolizumab with best supportive care (BSC) in 1005 adults with stage IB to 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.
Among 476 patients with stage II-IIIA NSCLC with PD-L1 expression on at least 1% of tumor cells, findings showed that 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; P =.004). In this patient population, median disease-free survival (DFS) was not reached (95% CI, 36.1 months-not estimable) in the atezolizumab treatment arm compared with 35.3 months for the BSC arm (29.0-not estimable).
In a prespecified secondary subgroup analysis of 229 patients with stage II-IIIA NSCLC whose tumors expressed PD-L1 of at least 50%, the median DFS was not reached (95% CI, 42.3 months-not estimable) in the atezolizumab arm and was 35.7 months (95% CI, 29.7-not estimable) in the BSC arm (HR, 0.43; 95% CI, 0.27-0.68).
In an exploratory subgroup analysis of 247 patients with stage II-IIIA NSCLC whose tumors expressed PD-L1 from 1 to 49%, the median DFS was 32.8 months (95% CI, 29.4-not estimable) in the atezolizumab arm and 31.4 months (95% CI, 24.0-not estimable) in the BSC arm (HR, 0.87; 95% CI, 0.60-1.26).
“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. “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.”
The VENTANA PD-L1 (SP263) Assay from Ventana Medical Systems, Inc. was also approved as a companion diagnostic device to select NSCLC patients for adjuvant treatment with Tecentriq.
- FDA approves atezolizumab as adjuvant treatment for non-small cell lung cancer. News release. US Food and Drug Administration. Accessed October 15, 2021. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-atezolizumab-adjuvant-treatment-non-small-cell-lung-cancer?utm_medium=email&utm_source=govdelivery.
- Tecentriq. Package insert. Genentech; 2021. Accessed October 15, 2021. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761034s042lbl.pdf.