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Pembrolizumab vs chemotherapy for previously untreated, PD-L1-expressing, locally advanced or metastatic non-small-cell lung cancer (KEYNOTE-042): A randomised, open-label, controlled, phase 3 trial

The Lancet Apr 10, 2019

Mok TSK, et al. - In this trial performed in 213 medical centers in 32 countries, researchers assessed overall survival of locally advanced or metastatic non-small-cell lung cancer patients with a programmed death ligand 1 (PD-L1) tumor proportion score (TPS) of 1% or more who was treated with first-line pembrolizumab monotherapy. In order to qualify, patients had to be adults (≥18 years) with previously untreated locally advanced or metastatic non-small-cell lung cancer without a sensitizing EGFR mutation or ALK translocation. In addition, patients with an Eastern Cooperative Oncology Group performance status score of 0 or 1, life expectancy 3 months or longer, and a PD-L1 TPS of 1% or greater were part of the eligibility criteria. This study included 1,274 patients (902 men, 372 women, median age 63 years [IQR 57–69]). Overall 637 received pembrolizumab and 637 received chemotherapy. In all TPS populations, overall survival was significantly greater in the pembrolizumab group vs the chemotherapy group. In patients with locally advanced or metastatic non-small-cell lung cancer without sensitizing EGFR or ALK alterations and with low PD-L1 TPS, pembrolizumab monotherapy can be used as first-line treatment, as seen via the benefit-to-risk profile.

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