Patients in the placebo arm with disease progression confirmed by blinded independent central review were permitted to crossover to monotherapy with pembrolizumab for up to 35 cycles. Following completion of chemotherapy, patients received pembrolizumab 200 mg or placebo according to initially assigned treatment until the completion of 35 cycles, disease progression, unacceptable adverse effects (AEs), or withdrawal. Eligible patients were randomly assigned 1:1 to receive either pembrolizumab at a dose of 200 mg every 3 weeks in combination with carboplatin area under the curve 6 mg/mL/minute plus paclitaxel 200 mg/m2 or nab-paclitaxel 100 mg/m2 on days 1, 8, and 15 every 3 weeks for 4 cycles or placebo plus the same chemotherapy regimen. The multicenter, double-blind KEYNOTE-407 trial enrolled patients with stage IV squamous NSCLC who had measurable disease per RECIST 1.1 criteria and provided tumor tissue for investigators to determine PD-L1 status. Previously, results from KEYNOTE-407 led to the FDA approval of pembrolizumab in combination with carboplatin and paclitaxel or nab-paclitaxel as a frontline treatment for patients with metastatic squamous NSCLC on October 30, 2018. The median time from randomization to data cutoff was 56.9 months (range, 49.9-66.2). 1įindings from the 5-year KEYNOTE-407 safety and efficacy analysis showed that patients in the intention-to-treat population who were treated with pembrolizumab plus chemotherapy (n = 278) experienced a median overall survival (OS) of 17.2 months (95% CI, 14.4-19.7) compared with 11.6 months (95% CI, 10.1-13.7) among the 281 patients who received placebo plus chemotherapy (HR, 0.71 95% CI, 0.59-0.85). Patients with treatment-naïve metastatic squamous non–small cell lung cancer (NSCLC) experienced a clinically meaningful survival benefit when treated with the PD-1–directed antibody pembrolizumab (Keytruda) in combination with chemotherapy compared with those who received chemotherapy alone, according to long-term follow-up data from the phase 3 KEYNOTE-407 trial (NCT02775435) published in the Journal of Clinical Oncology.
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