Keynote 177 colorectal8/12/2023 ![]() has received lecture fees and/or honoraria from Taiho Pharmaceutical Co., Ltd., Chugai Pharmaceutical Co., Ltd., Eli Lilly Japan K.K., Merck Biopharma Co., Ltd., Bayer Yakuhin, Ltd., Ono Pharmaceutical Co., Ltd., and MSD K.K. Cancer Science published by John Wiley & Sons Australia, Ltd on behalf of Japanese Cancer Association.ī.V.J., C.J.A.P., D.S., J.A.‐G., L.H.J., P.G., T.W.K., and W.P.Y have no conflicts of interest. © 2022 Merck Sharp & Dohme LLC and The Authors. identifier: NCT02563002.Īsia colorectal cancer microsatellite instability mismatch-repair deficiency pembrolizumab. These data support first-line pembrolizumab as a standard of care for patients from Asia with MSI-H/dMMR mCRC. Immune-mediated adverse events or infusion reactions were reported by six patients (27%) and 10 patients (40%), respectively. Grade 3/4 treatment-related adverse events (TRAEs) were reported by two patients (9%) in the pembrolizumab arm and 20 (80%) in the chemotherapy arm. Median PFS was not reached (NR 95% confidence interval 1.9 months-NR) with pembrolizumab versus 10.4 (95% CI 6.3-22.0) months with chemotherapy (hazard ratio 0.56, 95% CI 0.26-1.20). At FA, median time from randomization to data cutoff (February 19, 2021) was 45.3 (range 38.1-57.8) months with pembrolizumab and 43.9 (range 36.6-55.1) months with chemotherapy. A total of 48 patients from Japan, Korea, Singapore, and Taiwan (pembrolizumab, n = 22 chemotherapy, n = 26) were included. Here, we report results from the post hoc analysis of patients who were enrolled in Asia from the final analysis (FA) of KEYNOTE-177. Secondary endpoints were overall response rate (ORR) per RECIST v1.1 by BICR and safety. Primary endpoints were progression-free survival (PFS) per RECIST v1.1 by blinded independent central review (BICR) and overall survival (OS). The phase 3 KEYNOTE-177 study evaluated pembrolizumab versus chemotherapy with or without bevacizumab or cetuximab in patients with newly diagnosed, microsatellite-instability-high (MSI-H)/mismatch-repair-deficient (dMMR) metastatic colorectal cancer (mCRC). 19 Division of Solid Tumor Oncology, Memorial Sloan Kettering Cancer Center, New York, New York, USA.18 Merck & Co., Inc., Rahway, New Jersey, USA.17 The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins Medicine, Baltimore, Maryland, USA.16 Vall d'Hebron Barcelona Hospital Campus, Vall D'Hebron Institute of Oncology, Universitat Autònoma de Barcelona, Barcelona, Spain.15 Fernando Rivera, University Hospital Marqués de Valdecilla, IDIVAL, Santander, Spain. ![]()
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