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Original Article PD-1 Blockade in Tumors with Mismatch-Repair Deficiency Dung T. Le, M.D., Jennifer N. Uram, Ph.D., Hao Wang, Ph.D., Bjarne R. Bartlett, B.S., Holly Kemberling, R.N., Aleksandra D. Eyring, M.Pharm., Andrew D. Skora, Ph.D., Brandon S. Luber, Sc.M., Nilofer S.
Azad, M.D., Dan Laheru, M.D., Barbara Biedrzycki, Ph.D., C.N.R.P., Ross C. Donehower, M.D., Atif Zaheer, M.D., George A. Fisher, M.D., Ph.D., Todd S. Crocenzi, M.D., James J. Lee, M.D., Ph.D., Steven M. Duffy, M.D., Richard M. Goldberg, M.D., Albert de la Chapelle, M.D., Ph.D., Minori Koshiji, M.D., Ph.D., Feriyl Bhaijee, M.D., Thomas Huebner, M.D., Ralph H.
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Cornish, M.D., Ph.D., Janis M. Taube, M.D., Robert A. Anders, M.D., Ph.D., James R. Eshleman, M.D., Ph.D., Bert Vogelstein, M.D., and Luis A.
Diaz, Jr., M.D. N Engl J Med 2015; 372:2509-2520 DOI: 10.1056/NEJMoa1500596. Methods We conducted a phase 2 study to evaluate the clinical activity of pembrolizumab, an anti–programmed death 1 immune checkpoint inhibitor, in 41 patients with progressive metastatic carcinoma with or without mismatch-repair deficiency. Pembrolizumab was administered intravenously at a dose of 10 mg per kilogram of body weight every 14 days in patients with mismatch repair–deficient colorectal cancers, patients with mismatch repair–proficient colorectal cancers, and patients with mismatch repair–deficient cancers that were not colorectal. The coprimary end points were the immune-related objective response rate and the 20-week immune-related progression-free survival rate.