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010 EDITOR JAPANESE BLOCKS TRIAL

Overall survival was significantly longer for pembrolizumab 2 mg/kg versus docetaxel (hazard ratio 0.71, 95% CI 0.58-0.88 p=0.0008) and for pembrolizumab 10 mg/kg versus docetaxel (0.61, 0.49-0.75 p<0.0001). In the total population, median overall survival was 10.4 months with pembrolizumab 2 mg/kg, 12.7 months with pembrolizumab 10 mg/kg, and 8.5 months with docetaxel.

010 EDITOR JAPANESE BLOCKS TRIAL

This trial is registered at, number NCT01905657.īetween Aug 28, 2013, and Feb 27, 2015, we enrolled 1034 patients: 345 allocated to pembrolizumab 2 mg/kg, 346 allocated to pembrolizumab 10 mg/kg, and 343 allocated to docetaxel. We used a threshold for significance of p<0.00825 (one-sided) for the analysis of overall survival and a threshold of p<0.001 for progression-free survival. The primary endpoints were overall survival and progression-free survival both in the total population and in patients with PD-L1 expression on at least 50% of tumour cells. Patients with previously treated non-small-cell lung cancer with PD-L1 expression on at least 1% of tumour cells were randomly assigned (1:1:1) in blocks of six per stratum with an interactive voice-response system to receive pembrolizumab 2 mg/kg, pembrolizumab 10 mg/kg, or docetaxel 75 mg/m(2) every 3 weeks. We did this randomised, open-label, phase 2/3 study at 202 academic medical centres in 24 countries. We assessed the efficacy of pembrolizumab for patients with previously treated, PD-L1-positive, advanced non-small-cell lung cancer.

16 David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles, CA, USA.ĭespite recent advances in the treatment of advanced non-small-cell lung cancer, there remains a need for effective treatments for progressive disease.

14 Pontificia Universidad Católica de Chile, Santiago, Chile.

13 Instituto do Câncer do Estado de São Paulo, São Paulo, Brazil.

12 Rush University Medical Center, Chicago, IL, USA.

11 Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.

10 Samsung Medical Center Sungkyunkwan University School of Medicine, Seoul, South Korea.

9 Centre François Baclesse, Caen, France.

8 CHA Bundang Medical Center, CHA University, Gyeonggi-do, South Korea.

6 National Cancer Center, Goyang, South Korea.

5 Clinica Universidad de Navarra, Pamplona, Spain.

4 Vall D'Hebron University Hospital and Vall d'Hebron Institute of Oncology, Barcelona, Spain.3 Seoul National University Hospital, Seoul, South Korea.Electronic address: 2 The Netherlands Cancer Institute and The Academic Medical Hospital Amsterdam, Amsterdam, Netherlands. 1 Yale School of Medicine, Yale Cancer Center, and Smilow Cancer Hospital, New Haven, CT, USA.