{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,7]],"date-time":"2026-03-07T11:05:48Z","timestamp":1772881548475,"version":"3.50.1"},"reference-count":25,"publisher":"Oxford University Press (OUP)","issue":"1","license":[{"start":{"date-parts":[[2020,10,8]],"date-time":"2020-10-08T00:00:00Z","timestamp":1602115200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100010795","name":"Chugai Pharmaceutical","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100010795","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2021,1,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Objective<\/jats:title>\n                  <jats:p>A phase 1 dose-escalation study of polatuzumab vedotin (pola) was conducted to assess safety, pharmacokinetics and preliminary antitumor activity of pola in Japanese patients with relapsed\/refractory B-cell non-Hodgkin lymphoma.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>Patients received pola (1.0 or 1.8\u00a0mg\/kg) intravenously every 21\u00a0days until disease progression or intolerance. Intra-patient dose escalation was prohibited. Tolerability was determined by the standard 3\u00a0+\u00a03 rule. Blood sampling was performed to characterize pharmacokinetics. Antitumor activity was evaluated through computed tomography and bone marrow sampling.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Four patients received pola 1.0\u00a0mg\/kg; three received 1.8\u00a0mg\/kg. Patients had follicular lymphoma (n\u00a0=\u00a04) or diffuse large B-cell lymphoma (n\u00a0=\u00a03), median age of 62\u00a0years, received a median of 3 prior therapies; six were female. Pola was well tolerated in both cohorts, with no dose-limiting toxicities observed. The most common adverse event was peripheral sensory neuropathy (n\u00a0=\u00a04). Grade 3 adverse events were cholecystitis and neutrophil count decreased (one each; both 1.0\u00a0mg\/kg), and syncope and cataract (one each; both 1.8\u00a0mg\/kg). The plasma half-life of antibody-conjugate monomethyl auristatin E was 4.43\u20137.98\u00a0days, and systemic exposure of unconjugated monomethyl auristatin E was limited in both cohorts. Four patients achieved objective responses (three complete, one partial) without disease progression during the study.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>This phase 1 dose-escalation study demonstrated that pola has an acceptable safety profile and offers encouraging antitumor activity to Japanese patients with relapsed\/refractory B-cell non-Hodgkin lymphoma. Pola 1.8\u00a0mg\/kg, the recommended phase 2 dose, was tolerable in Japanese patients.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/jjco\/hyaa169","type":"journal-article","created":{"date-parts":[[2020,9,1]],"date-time":"2020-09-01T11:11:53Z","timestamp":1598958713000},"page":"70-77","source":"Crossref","is-referenced-by-count":11,"title":["Safety and pharmacokinetics of polatuzumab vedotin in Japanese patients with relapsed\/refractory B-cell non-Hodgkin lymphoma: a phase 1 dose-escalation study"],"prefix":"10.1093","volume":"51","author":[{"given":"Tomohiro","family":"Kinoshita","sequence":"first","affiliation":[{"name":"Department of Hematology and Cell Therapy, Aichi Cancer Center Hospital, Nagoya, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kiyohiko","family":"Hatake","sequence":"additional","affiliation":[{"name":"Department of Hematology Oncology, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8588-8955","authenticated-orcid":false,"given":"Kazuhito","family":"Yamamoto","sequence":"additional","affiliation":[{"name":"Department of Hematology and Cell Therapy, Aichi Cancer Center Hospital, Nagoya, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yusuke","family":"Higuchi","sequence":"additional","affiliation":[{"name":"Department of Hematology and Cell Therapy, Aichi Cancer Center Hospital, Nagoya, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Satsuki","family":"Murakami","sequence":"additional","affiliation":[{"name":"Department of Hematology and Cell Therapy, Aichi Cancer Center Hospital, Nagoya, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yasuhito","family":"Terui","sequence":"additional","affiliation":[{"name":"Department of Hematology Oncology, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Masahiro","family":"Yokoyama","sequence":"additional","affiliation":[{"name":"Department of Hematology Oncology, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Dai","family":"Maruyama","sequence":"additional","affiliation":[{"name":"Department of Hematology, National Cancer Center Hospital, Tokyo, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8985-8801","authenticated-orcid":false,"given":"Shinichi","family":"Makita","sequence":"additional","affiliation":[{"name":"Department of Hematology, National Cancer Center Hospital, Tokyo, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yukari","family":"Hida","sequence":"additional","affiliation":[{"name":"Clinical Sciecne & Stretegy Deparment, Chugai Pharmaceutical Co., 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