On October 15, 2021, the FDA accelerated the approval of a new indication for atezolizumab (Tecentriq; Genentech), for the adjuvant treatment, after resection and platinum-based chemotherapy, of patients with stage II-IIIA non–small-cell lung cancer (NSCLC) and PD-L1 expression ≥1%, as determined by an FDA-approved test.
Atezolizumab is the first immunotherapy to receive FDA approval for the adjuvant treatment of early-stage (stage II-IIIA) NSCLC. This approval was based on recent results from the phase 3 IMpower010 clinical trial.
Simultaneously, the FDA also approved the VENTANA PD-L1 Assay (Ventana Medical Systems) as a companion diagnostic test to identify appropriate patients with NSCLC for adjuvant treatment with atezolizumab.
“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, Co-Founder and Chair, GO2 Foundation for Lung Cancer. “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 major efficacy outcome was disease-free survival (DFS), as assessed by the investigator in the primary efficacy analysis population. The study included 476 patients with stage II-IIIA NSCLC and PD-L1 expression ≥1% who received atezolizumab or best supportive care.
The median DFS was not reached (95% confidence interval [CI], 36.1-not estimable [NE]) in the atezolizumab arm versus 35.3 months (95% CI, 29.0-NE) in patients in the best supportive care arm (hazard ratio, 0.66; 95% CI, 0.50-0.88; P = .004).
In a prespecified secondary subgroup analysis of patients with stage II-IIIA NSCLC and PD-L1 expression ≥50%, the hazard ratio for DFS was 0.43 (95% CI, 0.27- 0.68). And in an exploratory subgroup analysis of patients with stage II-IIIA NSCLC and PD-L1 expression of 1% to 49%, the hazard ratio for DFS was 0.87 (95% CI, 0.60-1.26).
The most common (≥10%) adverse reactions (including laboratory abnormalities) with atezolizumab in this study were increased aspartate aminotransferase, blood creatinine, and alanine aminotransferase; hyperkalemia, rash, cough, hypothyroidism, pyrexia, fatigue/asthenia, musculoskeletal pain, peripheral neuropathy, arthralgia, and pruritus.