He noted that an earlier study, Keynote-024, showed that pembrolizumab significantly improved progression-free survival in patients with tumors expressing PD-L1 on at least 50% of cells compared with standard platinum-based chemotherapy (10.3 vs. 6 months).
“This now more than doubles that population that can start immunotherapy as a first-line treatment, assuming the [Food and Drug Administration] modifies the label in accordance with this study,” he added.The Keynote-042 investigators enrolled 1,274 patients with locally advanced or metastatic NSCLC, and randomly assigned them to receive either a maximum of 35 cycles of pembrolizumab 200 mg every 3 weeks, or the investigators’ choice of not more than 6 cycles of either paclitaxel/carboplatin or pemetrexed/carboplatin, with optional pemetrexed maintenance for patients with nonsquamous histologies only.
The randomization was stratified by region (Asia vs. non–East Asia), Eastern Cooperative Oncology Group performance status 0 or 1, squamous vs. nonsquamous histology, and PD-L1 expression, or TPS (tumor proportion score) greater than 50% vs. 1%-49%.