The Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for atezolizumab (Tecentriq®; Genentech) as a first-line monotherapy in patients with advanced non-squamous and squamous non-small cell lung cancer (NSCLC) without EGFR or ALK mutations with high PD-L1 expression (TC3/IC3 wild-type [WT]), as determined by PD-L1 biomarker testing.
The sBLA includes data from the phase 3 IMpower110 study that compared the efficacy and safety of atezolizumab monotherapy to chemotherapy consisting of either cisplatin or carboplatin plus pemetrexed or gemcitabine in PD-L1-selected, chemotherapy-naive patients with stage IV non-squamous or squamous NSCLC without ALK or EGFR mutations for approximately 58 months (N=572). The primary end point was overall survival by PD-L1 subgroup, determined by an assessment of tumor cell (TC) and tumor-infiltrating immune cell (IC) levels.
Based on interim analysis, atezolizumab showed a statistically significant improvement in overall survival by 7.1 months compared with chemotherapy alone (median OS: 20.2 vs 13.1 months; hazard ratio [HR] 0.595, 95% CI, 0.398-0.890; P=.0106) in patients with high PD-L1 expression (TC3/IC3-WT). Regarding safety, atezolizumab exhibited a consistent profile with no new safety signals. Grade 3-4 treatment-related adverse events were observed to be lower in patients treated with atezolizumab compared with chemotherapy (12.9% vs 44.1%, respectively).
A Prescription Drug User Fee Act (PDUFA) target date of June 19, 2020 has been set for this application.
Atezolizumab (Tecentriq), a programmed death-ligand 1 (PD-L1) blocking antibody, is currently approved for the treatment of NSCLC, small cell lung cancer, triple-negative breast cancer, and urothelial carcinoma.
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