FDA Approves Atezolizumab for Metastatic NSCLC With High PD-L1 Expression
Posted: Thursday, May 21, 2020
On May 18, the U.S. Food and Drug Administration (FDA) approved the monoclonal-antibody atezolizumab (Tecentriq) as a first-line monotherapy for adults with metastatic non–small cell lung cancer (NSCLC). Treatment eligibility, by the recent FDA-approved companion diagnostic test, VENTANA PD-L1 (SP142) Assay, includes tumors with high PD-L1 expression or PD-L1–stained tumor-infiltrating immune cells covering 10% or more of the tumor area with no EGFR or ALK genomic tumor aberrations.
The FDA approval was based on the multicenter, international, open-label IMpower110 trial results. Patients with stage IV NSCLC tumors that express PD-L1 who had no prior chemotherapy were eligible for the study. Patients were randomly selected to receive 1,200 mg of atezolizumab every 3 weeks until disease progression or unacceptable toxicity or platinum-based chemotherapy.
The median overall survival was 20.2 months with atezolizumab compared with 13.1 months with chemotherapy (hazard ratio [HR] = 0.59; 95% confidence interval [CI] = 0.40–0.89; P = .0106). There was no statistically significant difference in overall survival for the other two PD-L1 subgroups. The median progression-free survival was 8.1 months with atezolizumab and 5.0 months with platinum-based chemotherapy (HR = 0.63; 95% CI = 0.45–0.88). In addition, the confirmed overall response rate was 38% (95% CI = 29%–48%) and 29% (95% CI = 20%–39%), respectively.
The most common adverse reaction observed in 20% or more of patients taking atezolizumab was fatigue/asthenia. Grade 3 and 4 treatment-related adverse events were also reported in 12.9% of patients administered atezolizumab compared with 44.1% of patients administered chemotherapy.
The recommended atezolizumab doses for NSCLC are 840 mg every 2 weeks, 1,200 mg every 3 weeks, or 1,680 mg every 4 weeks, administered intravenously over 60 minutes. For full prescribing information, visit accessdata.fda.gov.
