Pembrolizumab versus docetaxel for previously treated, PD-L1-positive, advanced non-small-cell lung cancer (KEYNOTE-010): a randomised controlled trial

• Published in: The Lancet (British edition) 2016-04, Vol.387 (10027), p.1540-1550
• Main Authors: Herbst, Roy S, Prof, Baas, Paul, Prof, Kim, Dong-Wan, MD, Felip, Enriqueta, MD, Pérez-Gracia, José L, MD, Han, Ji-Youn, Prof, Molina, Julian, MD, Kim, Joo-Hang, Prof, Arvis, Catherine Dubos, MD, Ahn, Myung-Ju, Prof, Majem, Margarita, MD, Fidler, Mary J, MD, de Castro, Gilberto, MD, Garrido, Marcelo, MD, Lubiniecki, Gregory M, MD, Shentu, Yue, PhD, Im, Ellie, MD, Dolled-Filhart, Marisa, PhD, Garon, Edward B, MD
• Format: Article
• Language: English
• Subjects: Adult; Aged; Antibodies, Monoclonal, Humanized - administration & dosage; Antibodies, Monoclonal, Humanized - adverse effects; Antibodies, Monoclonal, Humanized - therapeutic use; Antineoplastic Agents - administration & dosage; Antineoplastic Agents - adverse effects; Antineoplastic Agents - therapeutic use; B7-H1 Antigen - analysis; Biomarkers; Biopsy; Carcinoma, Non-Small-Cell Lung - chemistry; Carcinoma, Non-Small-Cell Lung - drug therapy; Carcinoma, Non-Small-Cell Lung - pathology; Chemotherapy; Clinical trials; Disease-Free Survival; Docetaxel; Drug Administration Schedule; Evidence-based medicine; FDA approval; Female; Gene Expression Regulation, Neoplastic; Genes; Health care facilities; Humans; Immunotherapy; Interactive systems; Internal Medicine; Kaplan-Meier Estimate; Lung cancer; Lung Neoplasms - chemistry; Lung Neoplasms - drug therapy; Lung Neoplasms - pathology; Male; Middle Aged; Molecular Targeted Therapy; Monoclonal antibodies; Mutation; Oncology; Patient Selection; Patients; PD-L1 protein; Pembrolizumab; Randomization; Risk assessment; Survival; Targeted cancer therapy; Taxoids - administration & dosage; Taxoids - adverse effects; Taxoids - therapeutic use; Treatment Outcome; Tumors
• ISSN: 0140-6736; 1474-547X
• DOI: 10.1016/S0140-6736(15)01281-7

Summary Background Despite recent advances in the treatment of advanced non-small-cell lung cancer, there remains a need for effective treatments for progressive disease. We assessed the efficacy of pembrolizumab for patients with previously treated, PD-L1-positive, advanced non-small-cell lung cancer. Methods We did this randomised, open-label, phase 2/3 study at 202 academic medical centres in 24 countries. 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/m2 every 3 weeks. 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. We used a threshold for significance of p