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An Immune Checkpoint Inhibitor for Patients with Platinum-Ineligible NSCLC
Pivotal trials support the use of PD-L1 inhibitors, with or without chemotherapy, as the standard-of-care first-line treatment for patients with advanced-stage non–small-cell lung cancer (NSCLC), but these studies have excluded patients ineligible for platinum-based doublet chemotherapy. As a result, many patients ineligible for platinum-based chemotherapy continue to receive single-agent chemotherapy. To compare possible treatments in this population, researchers conducted a manufacturer-funded, phase 3, open-label international trial in 453 patients who had stage IIIB or stage IV NSCLC lacking EGFR or ALK alterations. The investigators considered the patients unsuitable for platinum-doublet chemotherapy because they had an Eastern Cooperative Oncology Group (ECOG) performance status of 2 or 3, or they were at least 70 years old and had substantial comorbidities or contraindications.
The patients were randomized in a 2:1 ratio to atezolizumab 1200 mg every 3 weeks or to one of two chemotherapies — vinorelbine or gemcitabine in 3-weekly or 4-weekly cycles. The primary endpoint was overall survival. Treatment with atezolizumab was associated with significantly longer overall survival compared with single-agent chemotherapy (10.3 months vs. 9.2 months; stratified hazard ratio, 0.78). Moreover, 2-year survival was 24% with atezolizumab, double the rate with chemotherapy (12%). No new safety signals were seen with atezolizumab, and the incidence of treatment-related adverse events (grade 3 or 4) was half that seen in the chemotherapy arm (16% and 33%).
This trial provides clinically relevant evidence for the treatment of patients with advanced NSCLC who are routinely excluded from registrational trials. Significant work remains as the patients in this trial had poor outcomes regardless of therapy. Still, clearly, we can conduct further meaningful trials in similar real-world populations.
Lee SM et al.
Title: First-line atezolizumab monotherapy versus single-agent chemotherapy in patients with non-small-cell lung cancer ineligible for treatment with a platinum-containing regimen (IPSOS): A phase 3, global, multicentre, open-label, randomised controlled study.
Source: Lancet 2023 Aug 5; [e-pub]. (Abstract/FREE Full Text)