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Tumor responses were assessed by investigators every 9\u00a0weeks using the Response Evaluation Criteria in Solid Tumors version 1.1.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Of 13 patients enrolled, median age was 62\u00a0years (range 33\u201375) and eight patients were female. Median duration of cemiplimab exposure was 13.1\u00a0weeks (range 3.0\u2012113.6). At the time of data cut-off, 11 patients (84.6%) had discontinued treatment (majority due to disease progression:\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u20098, 61.5%). The most common treatment-emergent adverse events (TEAEs) of any grade were contact dermatitis, rash, and viral upper respiratory tract infection (each\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u20093, 23.1%). Five grade\u2009\u2265\u20093 TEAEs were reported in four patients: autoimmune colitis, dehydration, hyponatremia, hypophosphatemia, and muscular weakness. No dose-limiting toxicities were reported and no TEAEs led to death. Cemiplimab concentrations in serum were consistent with previously reported pharmacokinetic characteristics of cemiplimab. No anti-drug antibodies were detected in serum. Objective response rate [ORR; complete response\u2009+\u2009partial response (PR)] was 30.8% (four PR) and disease control rate [ORR\u2009+\u2009stable disease (SD)] was 46.2% (6\/13; two SD).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>Cemiplimab exhibited antitumor activity in Japanese patients with advanced malignancies. The safety profile was comparable to those previously reported for cemiplimab and other PD-1 inhibitors.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration<\/jats:title>\n                    <jats:p>NCT03233139 at ClinicalTrials.gov.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Graphic abstract<\/jats:title>\n                  <\/jats:sec>","DOI":"10.1007\/s00280-020-04161-6","type":"journal-article","created":{"date-parts":[[2020,11,4]],"date-time":"2020-11-04T07:45:54Z","timestamp":1604475954000},"page":"53-64","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":12,"title":["Dose exploration results from Phase 1 study of cemiplimab, a human monoclonal programmed death (PD)-1 antibody, in Japanese patients with advanced malignancies"],"prefix":"10.1007","volume":"87","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4041-8298","authenticated-orcid":false,"given":"Shigehisa","family":"Kitano","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Toshio","family":"Shimizu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takafumi","family":"Koyama","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takahiro","family":"Ebata","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Satoru","family":"Iwasa","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shunsuke","family":"Kondo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Akihiko","family":"Shimomura","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yutaka","family":"Fujiwara","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Noboru","family":"Yamamoto","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anne","family":"Paccaly","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Siyu","family":"Li","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Petra","family":"Rietschel","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tasha","family":"Sims","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2020,11,4]]},"reference":[{"issue":"5","key":"4161_CR1","doi-asserted-by":"publisher","first-page":"861","DOI":"10.1158\/1535-7163.MCT-16-0665","volume":"16","author":"E Burova","year":"2017","unstructured":"Burova E, Hermann A, Waite J, Potocky T, Lai VSH, Liu M, Allbritton O, Woodruff A, Wu Q, D\u2019Orvilliers A, Garnova E, Rafique A, Poueymirou W, Martin J, Huang T, Skokos D, Kantrowitz J, Popke J, Mohrs M, MacDonald D, Ioffe E, Olson W, Lowy I, Murphy A, Thurston G (2017) Characterization of the anti-PD-1 antibody REGN2810 and its antitumor activity in human PD-1 knock-in mice. 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TS: Institutional research expenses from Regeneron Pharmaceuticals, Inc. during the conduct of the study; institutional research expenses from Novartis, Eli Lilly, AbbVie, AstraZeneca, Eisai, Astellas, Chordia Therapeutics, Bristol-Myers Squibb, Daiichi-Sankyo, Milleniam-Takeda, PharmaMar, FivePrime, 3D-Medicine and Symbio-Pharma, advisory role personal fees from Milleniam-Takeda, personal lecture fees from Boehringer Ingelheim, Taiho Pharma, Chugai Pharmaceutical, Co., Ltd., Ono Pharmaceutical Co., Ltd., Ono Pharma Taiwan Co., Ltd., outside the submitted work. TK, TE, SI, SK, AS: No conflict of interest declared. YF: Research funding grants from Abbie, AstraZeneca, Bristol-Myers Squibb, Chugai, Daiichi-Sankyo, Eisai, Eli Lilly, Incyte, Merck Serono, MSD, and Novartis; advisory role personal fees from AstraZeneca, Bristol-Myers Squibb, Novartis, and Ono Pharmaceutical Co., Ltd., speaker\u2019s bureau personal fees from Bristol-Myers Squibb, Ono Pharmaceutical Co., Ltd., and Taiho, all outside of the submitted work. NY: Research grants from Chugai, Taiho, Eisai, Lilly, Quintiles, Astellas, Bristol-Myers Squibb, Novartis, Daiichi-Sankyo, Pfizer, Boehringer Ingelheim, Kyowa-Hakko Kirin, Bayer, Ono Pharmaceutical Co., Ltd. and Takeda; honoraria from Ono Pharmaceutical Co., Ltd., Chugai, AstraZeneca, Pfizer, Lilly, Bristol-Myers Squibb; and consulting fees from Eisai, Otsuka, Takeda, and Boehringer Ingelheim, outside the submitted work. AP, SL, PR, TS: Employee and shareholder of Regeneron Pharmaceuticals, Inc.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"This study was conducted in accordance with the principles of the Declaration of Helsinki and the International Conference on Harmonization Guidelines for Good Clinical Practice. The study protocol was approved by ethics committees.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Statement of human and animal rights"}},{"value":"Informed consent was obtained from all individual participants included in the study. This article does not report data from animals performed by any of the authors.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Informed consent"}},{"value":"Qualified researchers may request access to study documents (including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan) that support the methods and findings reported in this manuscript. Individual anonymized participant data will be considered for sharing once the product and indication has been approved by major health authorities (e.g., FDA, EMA, PMDA, etc.), if there is legal authority to share the data and there is not a reasonable likelihood of participant re-identification. Submit requests to\n                      \n                      .","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Data sharing"}}]}}