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N Engl J Med. 2016 Nov 10;375(19):1823-1833. Epub 2016 Oct 8.

Pembrolizumab versus Chemotherapy for PD-L1-Positive Non-Small-Cell Lung Cancer.

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From Lung Clinic Grosshansdorf, Airway Research Center North, German Center of Lung Research, Grosshansdorf, Germany (M.R.); Hospital Universitario Insular de Gran Canaria, Las Palmas, Spain (D.R.-A.); Cancer Centre of Southeastern Ontario at Kingston General Hospital, Kingston, ON, Canada (A.G.R.); Westmead Hospital and the University of Sydney, Sydney (R.H.), and Southern Medical Day Care Centre, Wollongong, NSW (A.T.) - both in Australia; Jász-Nagykun-Szolnok County Hospital, Szolnok (T.C.), and Országos Korányi TBC és Pulmonológiai Intézet, Budapest (A.F.) - both in Hungary; Meir Medical Center, Kfar-Saba (M.G.), and Davidoff Cancer Center, Tel Aviv University, Petah Tikva (N.P.) - both in Israel; St. James's Hospital and Cancer Trials Ireland, Dublin (S.C.); the Royal Marsden Hospital, Sutton, Surrey, United Kingdom (M.O.); MedStar Franklin Square Hospital (S.R.) and Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins (J.R.B.) - both in Baltimore; Okayama University Hospital, Okayama, Japan (K.H.); and Merck, Kenilworth, NJ (M.A.L., G.M.L., Y.S., R.R.).



Pembrolizumab is a humanized monoclonal antibody against programmed death 1 (PD-1) that has antitumor activity in advanced non-small-cell lung cancer (NSCLC), with increased activity in tumors that express programmed death ligand 1 (PD-L1).


In this open-label, phase 3 trial, we randomly assigned 305 patients who had previously untreated advanced NSCLC with PD-L1 expression on at least 50% of tumor cells and no sensitizing mutation of the epidermal growth factor receptor gene or translocation of the anaplastic lymphoma kinase gene to receive either pembrolizumab (at a fixed dose of 200 mg every 3 weeks) or the investigator's choice of platinum-based chemotherapy. Crossover from the chemotherapy group to the pembrolizumab group was permitted in the event of disease progression. The primary end point, progression-free survival, was assessed by means of blinded, independent, central radiologic review. Secondary end points were overall survival, objective response rate, and safety.


Median progression-free survival was 10.3 months (95% confidence interval [CI], 6.7 to not reached) in the pembrolizumab group versus 6.0 months (95% CI, 4.2 to 6.2) in the chemotherapy group (hazard ratio for disease progression or death, 0.50; 95% CI, 0.37 to 0.68; P<0.001). The estimated rate of overall survival at 6 months was 80.2% in the pembrolizumab group versus 72.4% in the chemotherapy group (hazard ratio for death, 0.60; 95% CI, 0.41 to 0.89; P=0.005). The response rate was higher in the pembrolizumab group than in the chemotherapy group (44.8% vs. 27.8%), the median duration of response was longer (not reached [range, 1.9+ to 14.5+ months] vs. 6.3 months [range, 2.1+ to 12.6+]), and treatment-related adverse events of any grade were less frequent (occurring in 73.4% vs. 90.0% of patients), as were grade 3, 4, or 5 treatment-related adverse events (26.6% vs. 53.3%).


In patients with advanced NSCLC and PD-L1 expression on at least 50% of tumor cells, pembrolizumab was associated with significantly longer progression-free and overall survival and with fewer adverse events than was platinum-based chemotherapy. (Funded by Merck; KEYNOTE-024 number, NCT02142738 .).

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