Genentech announced positive data from the phase 3 IMpower110 study of atezolizumab as first-line monotherapy in advanced non-squamous and squamous non-small cell lung cancer (NSCLC) without ALK or EGFR mutations (wild-type; WT).

IMpower110 is an open-label, randomized study comparing 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 of the trial is overall survival (OS) by PD-L1 subgroup, determined by an assessment of tumor cell (TC) and tumor-infiltrating immune cell (IC) levels; key secondary end points included progression-free survival (PFS), objective response rate (ORR) and duration of response (DoR).

Based on interim analysis, atezolizumab showed a statistically significant improvement in OS by 7.1 months compared with chemotherapy alone (median OS: 20.2 versus 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). Similarly, atezolizumab improved OS compared with chemotherapy (18.2 versus 14.9 months; HR=0.717, 95% CI: 0.520–0.989) in patients with medium PD-L1 expression (TC2/3 or IC2/3-WT), but the data did not reach statistical significance. Final analysis of the study will evaluate the efficacy of atezolizumab in patients with low PD-L1 expression. Regarding safety, atezolizumab exhibited a consistent profile with no new safety signals.

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“We are excited to share these positive data, showing that [atezolizumab] alone offers a significant survival benefit over chemotherapy as an initial treatment in people with squamous or non-squamous non-small cell lung cancer with high PD-L1 expression,” said Sandra Horning, MD, chief medical officer and head of Global Product Development. “The IMpower110 results demonstrate the potential of first-line [atezolizumab] monotherapy in certain types of advanced lung cancer, and could provide an additional treatment option for oncologists and the patients that they treat.”

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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