Phase 3 trial of first-line pembrolizumab with or without platinum-based chemotherapy in advanced NSCLC expressing PD-L1≥ 50%

The phase 3 PERSEE trial, at 28 centers in France, compared first-line pembrolizumab with or without platinum-based chemotherapy in advanced non-small cell lung cancer (NSCLC) with high PD-L1 expression (≥ 50%) without actionable oncogenic alterations. In this trial, adult patients with treatment-naïve stage IV or unresectable stage III not amenable to definitive radiotherapy and PD-L1 expression ≥ 50% were randomized 1:1 to receive pembrolizumab 200 mg every 3 weeks, for up to 35 cycles plus four cycles of induction chemotherapy (n=160) or pembrolizumab monotherapy (n=161). The primary endpoint was progression-free survival (PFS) assesed by blinded central review. At a median follow-up of 38.7 months, median PFS was significantly longer with combination therapy than with monotherapy (16.1 months versus 6.9 months (HR 0.56; p<0.001); median overall survival was 50.2 months versus 29.9 months (HR 0.77; 95% CI 0.56-1.05); grade ≥ treatment-related adverse events occurred in 54% and 19% of patients, respectively. The authors conclude that among patients with treatment-naïve advanced NSCLC and high PD-L1 expression, addition of platinum-based chemotherapy to pembrolizumab significantly prolonged PFS (graphical abstract).