{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,19]],"date-time":"2026-10-19T21:41:53Z","timestamp":1792446113096,"version":"4.5.0"},"reference-count":23,"publisher":"Wiley","issue":"8","license":[{"start":{"date-parts":[[2022,6,15]],"date-time":"2022-06-15T00:00:00Z","timestamp":1655251200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Cancer Science"],"published-print":{"date-parts":[[2022,8]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>\n                    New treatments, particularly second\u2010line options, are needed to improve outcomes for patients with recurrent\/metastatic cervical cancer (r\/mCC). Tisotumab vedotin (TV) is an antibody\u2013drug conjugate directed to tissue factor, a transmembrane protein commonly expressed in cancer cells, to deliver cytotoxic monomethyl auristatin E. This single\u2010arm, open\u2010label phase 1\/2 trial evaluated the consistency of safety and efficacy outcomes of TV in Japanese patients with r\/mCC to bridge the current findings with those reported in previous trials in non\u2010Japanese patients in the United States and Europe. In part 1 (dose escalation;\n                    <jats:italic>N<\/jats:italic>\n                    \u00a0=\u20096), patients with advanced solid tumors received TV 1.5 or 2.0\u2009mg\/kg once every 3\u2009weeks to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D). Part 2 (dose expansion;\n                    <jats:italic>N<\/jats:italic>\n                    \u00a0=\u200917) evaluated the RP2D in r\/mCC patients with 1\u20132 prior lines of therapy. In part 1, no dose\u2010limiting toxicities were observed, the MTD was not reached, and TV 2.0\u2009mg\/kg was established as the RP2D. In part 2, the most common treatment\u2010emergent adverse events were anemia (58.8%), nausea (58.8%), alopecia (47.1%), epistaxis (47.1%), and diarrhea (35.3%); adverse events of special interest were bleeding (76.5%), ocular events (35.3%), and peripheral neuropathy (17.6%), and were mostly grade 1\/2. In part 2, confirmed objective response rate was 29.4%, median duration of response was 7.1\u2009months, and median time to response was 1.2\u2009months. In Japanese patients with r\/mCC, TV demonstrated a manageable and tolerable safety, pharmacokinetics, and efficacy profile consistent with that observed in non\u2010Japanese patients.\n                  <\/jats:p>","DOI":"10.1111\/cas.15443","type":"journal-article","created":{"date-parts":[[2022,5,28]],"date-time":"2022-05-28T05:23:22Z","timestamp":1653715402000},"page":"2788-2797","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":34,"title":["Tisotumab vedotin in Japanese patients with recurrent\/metastatic cervical cancer: Results from the\n                    <scp>innovaTV<\/scp>\n                    206 study"],"prefix":"10.1111","volume":"113","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-7624-7611","authenticated-orcid":false,"given":"Kan","family":"Yonemori","sequence":"first","affiliation":[{"name":"National Cancer Center Hospital  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yasutoshi","family":"Kuboki","sequence":"additional","affiliation":[{"name":"National Cancer Center Hospital East  Chiba Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kosei","family":"Hasegawa","sequence":"additional","affiliation":[{"name":"Saitama Medical University International Medical Center  Saitama Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takashi","family":"Iwata","sequence":"additional","affiliation":[{"name":"Keio University School of Medicine  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hidenori","family":"Kato","sequence":"additional","affiliation":[{"name":"National Hospital Organization Hokkaido Cancer Center  Sapporo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8808-3338","authenticated-orcid":false,"given":"Kazuhiro","family":"Takehara","sequence":"additional","affiliation":[{"name":"NHO Shikoku Cancer Center  Matsuyama Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yasuyuki","family":"Hirashima","sequence":"additional","affiliation":[{"name":"Shizuoka Cancer Center  Shizuoka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hisamori","family":"Kato","sequence":"additional","affiliation":[{"name":"Kanagawa Cancer Center  Kanagawa Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chaitali","family":"Passey","sequence":"additional","affiliation":[{"name":"Genmab US, Inc.  Princeton New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jeppe Klint","family":"Buchbjerg","sequence":"additional","affiliation":[{"name":"Genmab A\/S  Copenhagen Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jeffrey R.","family":"Harris","sequence":"additional","affiliation":[{"name":"Genmab US, Inc.  Princeton New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Camilla\u00a0Mondrup","family":"Andreassen","sequence":"additional","affiliation":[{"name":"Genmab A\/S  Copenhagen Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Leonardo","family":"Nicacio","sequence":"additional","affiliation":[{"name":"Seagen Inc.  Bothell WA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ibrahima","family":"Soumaoro","sequence":"additional","affiliation":[{"name":"Genmab US, Inc.  Princeton New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Keiichi","family":"Fujiwara","sequence":"additional","affiliation":[{"name":"Saitama Medical University International Medical Center  Saitama Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2022,6,15]]},"reference":[{"key":"e_1_2_11_2_1","doi-asserted-by":"publisher","DOI":"10.3322\/caac.21492"},{"key":"e_1_2_11_3_1","unstructured":"World Health Organization.Cancer Fact Sheets: Cervical Cancer."},{"key":"e_1_2_11_4_1","doi-asserted-by":"publisher","DOI":"10.3802\/jgo.2017.28.e32"},{"key":"e_1_2_11_5_1","doi-asserted-by":"publisher","DOI":"10.3390\/ijerph17207401"},{"key":"e_1_2_11_6_1","doi-asserted-by":"publisher","DOI":"10.1002\/ijc.32014"},{"key":"e_1_2_11_7_1","unstructured":"National Cancer Center Cancer Information Service.Cancer type statistics: cervix. Accessed March 2022.https:\/\/ganjoho.jp\/reg_stat\/statistics\/stat\/cancer\/17_cervix_uteri.html"},{"key":"e_1_2_11_8_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2014.58.4391"},{"key":"e_1_2_11_9_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1309748"},{"key":"e_1_2_11_10_1","doi-asserted-by":"publisher","DOI":"10.1007\/s10147-018-1351-y"},{"key":"e_1_2_11_11_1","unstructured":"US Food and Drug Administration.Keytruda [package insert].Merck Sharp Dohme. Accessed May 2022.https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/125514Orig1s054lbl.pdf"},{"key":"e_1_2_11_12_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2112435"},{"key":"e_1_2_11_13_1","unstructured":"NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines).Cervical Cancer. Accessed May 2022.https:\/\/www.nccn.org\/patients\/guidelines\/content\/PDF\/cervical\u2010patient\u2010guideline.pdf."},{"key":"e_1_2_11_14_1","unstructured":"Safety and efficacy of tisotumab vedotin monotherapy & in combination with other cancer agents in subjects with cervical cancer. Accessed March 2022.https:\/\/clinicaltrials.gov\/ct2\/show\/NCT03786081"},{"key":"e_1_2_11_15_1","unstructured":"Efficacy and safety study of tisotumab vedotin for patients with solid tumors (innovaTV 207). Accessed March 2022.https:\/\/clinicaltrials.gov\/ct2\/show\/NCT03485209"},{"key":"e_1_2_11_16_1","doi-asserted-by":"publisher","DOI":"10.1158\/0008-5472.CAN-13-2440"},{"key":"e_1_2_11_17_1","doi-asserted-by":"publisher","DOI":"10.1158\/1535-7163.MCT-14-0798"},{"key":"e_1_2_11_18_1","doi-asserted-by":"publisher","DOI":"10.2119\/2003-00047.versteeg"},{"key":"e_1_2_11_19_1","doi-asserted-by":"publisher","DOI":"10.3892\/etm.2018.6723"},{"key":"e_1_2_11_20_1","doi-asserted-by":"publisher","DOI":"10.1186\/1471-2407-11-263"},{"key":"e_1_2_11_21_1","doi-asserted-by":"publisher","DOI":"10.1158\/1078-0432.CCR-19-2962"},{"key":"e_1_2_11_22_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1470-2045(21)00056-5"},{"key":"e_1_2_11_23_1","unstructured":"US Food and Drug AdministrationTivdak\u2122 (tisotumab verdotin\u2010tftv) [package insert].Seagen Inc. Updated September 2021. Accessed October 6 2021.https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2021\/761208Orig1s000lbledt.pdf"},{"key":"e_1_2_11_24_1","unstructured":"Pharmaceuticals and Medical Devices Agency (PMDA)Basic principles on Global Clinical Trials. Accessed July 12 2021.https:\/\/www.pmda.go.jp\/files\/000153265.pdf"}],"container-title":["Cancer Science"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/cas.15443","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/cas.15443","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/cas.15443","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,8,22]],"date-time":"2023-08-22T12:40:11Z","timestamp":1692708011000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/cas.15443"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,6,15]]},"references-count":23,"journal-issue":{"issue":"8","published-print":{"date-parts":[[2022,8]]}},"alternative-id":["10.1111\/cas.15443"],"URL":"https:\/\/doi.org\/10.1111\/cas.15443","archive":["Portico"],"relation":{},"ISSN":["1347-9032","1349-7006"],"issn-type":[{"value":"1347-9032","type":"print"},{"value":"1349-7006","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022,6,15]]},"assertion":[{"value":"2022-02-02","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2022-05-22","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2022-06-15","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}