Abstract
Cytotoxic agents have immunomodulatory effects, providing a rationale for combining atezolizumab (anti-programmed death-ligand 1 [anti-PD-L1]) with chemotherapy. The randomized phase III IMpower131 study (NCT02367794) evaluated atezolizumab with platinum-based chemotherapy in stage IV squamous NSCLC. A total of 1021 patients were randomized 1:1:1 to receive atezolizumab+carboplatin+paclitaxel (A+CP) (n= 338), atezolizumab+carboplatin+nab-paclitaxel (A+CnP) (n= 343), or carboplatin+nab-paclitaxel (CnP) (n= 340) for four or six 21-day cycles; patients randomized to the A+CP or A+CnP arms received atezolizumab maintenance therapy until progressive disease or loss of clinical benefit. The coprimary end points were investigator-assessed progression-free survival (PFS) and overall survival (OS) in the intention-to-treat (ITT) population. The secondary end points included PFS and OS in PD-L1 subgroups and safety. The primary PFS (January 22, 2018) and final OS (October 3, 2018) for A+CnP versus CnP are reported. PFS improvement with A+CnP versus CnP was seen in the ITT population (median, 6.3 versus 5.6 mo; hazard ratio [HR]= 0.71, 95% confidence interval [CI]: 0.60-0.85; p= 0.0001). Median OS in the ITT population was 14.2 and 13.5 months in the A+CnP and CnP arms (HR= 0.88, 95% CI: 0.73-1.05; p= 0.16), not reaching statistical significance. OS improvement with A+CnP versus CnP was observed in the PD-L1-high subgroup (HR= 0.48, 95% CI: 0.29-0.81), despite not being formally tested. Treatment-related grade 3 and 4 adverse events and serious adverse events occurred in 68.0% and 47.9% (A+CnP) and 57.5% and 28.7% (CnP) of patients, respectively. Adding atezolizumab to platinum-based chemotherapy significantly improved PFS in patients with first-line squamous NSCLC; OS was similar between the arms.
Highlights
Cytotoxic agents have immunomodulatory effects, providing a rationale for combining atezolizumab with chemotherapy
Patients A total of 1021 patients were enrolled at 317 study sites across 26 countries between June 2015 and March 2017 and comprised the ITT population
Median overall survival (OS) in the ITT population was similar between the AþCnP and CnP arms: 14.2 months and 13.5 months, respectively (Fig. 1B, Supplementary Fig. 4)
Summary
Cytotoxic agents have immunomodulatory effects, providing a rationale for combining atezolizumab (anti-programmed death-ligand 1 [anti–PD-L1]) with chemotherapy. The randomized phase III IMpower[131] study (NCT02367794) evaluated atezolizumab with platinum-based chemotherapy in stage IV squamous NSCLC. Platinum-based chemotherapy remains a first-line treatment option for many patients with advanced squamous NSCLC, which accounts for 25% to 30% of lung cancers.[1,2,3] these treatment options provide limited efficacy, with a median overall survival (OS) of less than 1 year.[3] More recently, the introduction
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