The Food and Drug Administration (FDA) has approved Tecentriq® (atezolizumab; Genentech) as a first-line treatment for adults with metastatic non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression (PD-L1 stained ≥50% of tumor cells [TC ≥50%] or PD-L1 stained tumor-infiltrating immune cells [IC] covering ≥10% of the tumor area [IC ≥10%]), as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations. In addition, the Agency approved a companion diagnostic test, the Ventana PD-L1 (SP142) Assay (Ventana Medical Systems, Inc) for use in selecting NSCLC patients for treatment with atezolizumab.
The approval was based on data from the phase 3 IMpower110 study that compared the efficacy and safety of atezolizumab monotherapy to platinum-based chemotherapy in PD-L1-selected, chemotherapy-naive patients with stage IV NSCLC without ALK or EGFR mutations.
Interim analysis showed that atezolizumab improved overall survival (primary end point) by 7.1 months compared with chemotherapy alone (median OS: 20.2 vs 13.1 months; hazard ratio [HR] 0.59; 95% CI, 0.40-0.89; P =.0106) in patients with high PD-L1 expression (TC ≥50% or IC ≥10%). There was no statistically significant difference in OS for the other 2 PD-L1 subgroups (TC ≥5% or IC ≥5%; and TC ≥1% or IC ≥1%) at the interim or final analyses.
The safety of atezolizumab was consistent with its known profile; no new safety signals were observed in the study. Grade 3-4 treatment-related adverse events were found to be lower in patients treated with atezolizumab compared with chemotherapy (12.9% vs 44.1%, respectively).
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