{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,11,6]],"date-time":"2025-11-06T10:44:58Z","timestamp":1762425898534,"version":"build-2065373602"},"reference-count":14,"publisher":"Wiley","issue":"11","license":[{"start":{"date-parts":[[2025,9,8]],"date-time":"2025-09-08T00:00:00Z","timestamp":1757289600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Cancer Science"],"published-print":{"date-parts":[[2025,11]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:p>\n                    Epidermal growth factor receptor (EGFR) exon 20 insertion mutations (EGFR Exon 20ins) are the third most common mutations in non\u2010small cell lung cancer (NSCLC) and are associated with a poorer prognosis and resistance to conventional EGFR\u2010tyrosine kinase inhibitors. This subpopulation analysis of the open\u2010label phase 3 trial (PAPILLION) evaluates the efficacy and safety of amivantamab\u2013chemotherapy versus chemotherapy among Japanese patients with locally advanced or metastatic NSCLC with EGFR Exon 20ins mutation (\n                    <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"http:\/\/clinicaltrials.gov\">ClinicalTrials.gov<\/jats:ext-link>\n                    , NCT04538664). Patients were randomized 1:1 to either intravenous amivantamab plus carboplatin\/pemetrexed chemotherapy or chemotherapy alone. The primary endpoint was progression\u2010free survival (PFS) by blinded independent central review; the secondary endpoints included objective response rate, duration of response, PFS after first subsequent therapy, overall survival, and safety. The overall population (\n                    <jats:italic>n<\/jats:italic>\n                    \u2009=\u2009308) included 34 Japanese patients (amivantamab\u2013chemotherapy,\n                    <jats:italic>n<\/jats:italic>\n                    \u2009=\u200919; chemotherapy,\n                    <jats:italic>n<\/jats:italic>\n                    \u2009=\u200915). Median PFS was 15.5 (95% CI 8.0, NE) months with amivantamab\u2013chemotherapy compared with 5.6 (95% CI 3.0, 7.0) months (HR\u2009=\u20090.22 [0.09, 0.53]) for chemotherapy alone. Improvements in secondary endpoints were also greater in the amivantamab\u2013chemotherapy arm than the chemotherapy arm. The predominant adverse events associated with amivantamab\u2013chemotherapy were reversible hematologic and EGFR\u2010related toxic effects; 2 of 19 patients discontinued all study agents due to treatment\u2010emergent adverse events. Efficacy and safety results in this Japanese subpopulation were consistent with those in the overall population and support the first\u2010line use of amivantamab\u2013chemotherapy in this setting. Early identification of patients with EGFR Exon 20ins mutations, preferably with more sensitive next\u2010generation sequencing\u2010based methods, is important to ensure appropriate patient access to amivantamab\u2013chemotherapy.\n                  <\/jats:p>\n                  <jats:p>\n                    <jats:bold>Trial Registration:<\/jats:bold>\n                    <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"http:\/\/clinicaltrials.gov\">ClinicalTrials.gov<\/jats:ext-link>\n                    , NCT04538664.\n                  <\/jats:p>","DOI":"10.1111\/cas.70180","type":"journal-article","created":{"date-parts":[[2025,9,9]],"date-time":"2025-09-09T06:51:41Z","timestamp":1757400701000},"page":"3139-3148","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Amivantamab Plus Chemotherapy in Japanese Patients With\n                    <scp>EGFR<\/scp>\n                    Exon 20 Insertions\n                    <scp>NSCLC<\/scp>"],"prefix":"10.1111","volume":"116","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7371-2787","authenticated-orcid":false,"given":"Satoru","family":"Kitazono","sequence":"first","affiliation":[{"name":"Department of Medical Affairs At Janssen Pharmaceutical K.K  Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Akira","family":"Ono","sequence":"additional","affiliation":[{"name":"Division of Thoracic Oncology Shizuoka Cancer Center  Shizuoka Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tetsuji","family":"Kawamura","sequence":"additional","affiliation":[{"name":"Department of Respiratory Medicine NHO Himeji Medical Center  Hyogo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Osamu","family":"Hataji","sequence":"additional","affiliation":[{"name":"Respiratory Center Matsusaka Municipal Hospital  Mie Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hiroshi","family":"Tanaka","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine Niigata Cancer Center Hospital  Niigata Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shingo","family":"Matsumoto","sequence":"additional","affiliation":[{"name":"Department of Thoracic Oncology National Cancer Center Hospital East  Kashiwa Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Naohiro","family":"Watanabe","sequence":"additional","affiliation":[{"name":"Department of Thoracic Oncology Aichi Cancer Center Hospital  Aichi Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hiromi","family":"Nagashima","sequence":"additional","affiliation":[{"name":"Division of Pulmonary Medicine, Department of Internal Medicine Iwate Medical University  Iwate Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Masahide","family":"Oki","sequence":"additional","affiliation":[{"name":"Department of Respiratory Medicine NHO Nagoya Medical Center  Aichi Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Michiko","family":"Takahashi","sequence":"additional","affiliation":[{"name":"Department of Medical Affairs Janssen Pharmaceutical K.K  Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tomoko","family":"Anazawa","sequence":"additional","affiliation":[{"name":"Clinical Science Division, Research &amp; Development Janssen Pharmaceutical K.K  Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Takahiro","family":"Shirai","sequence":"additional","affiliation":[{"name":"Clinical Science Division, Research &amp; Development Janssen Pharmaceutical K.K  Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Aimi","family":"Yamashita","sequence":"additional","affiliation":[{"name":"Department of Statistics &amp; Decision Sciences Janssen JP Janssen Pharmaceutical K.K  Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Honeylet","family":"Wortman\u2010Vayn","sequence":"additional","affiliation":[{"name":"Janssen R&amp;D, Spring House  Pennsylvania USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Archan","family":"Bhattacharya","sequence":"additional","affiliation":[{"name":"Janssen Research &amp; Development High Wycombe  UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Trishala","family":"Agrawal","sequence":"additional","affiliation":[{"name":"Janssen R&amp;D, Spring House  Pennsylvania USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mahadi","family":"Baig","sequence":"additional","affiliation":[{"name":"Janssen R&amp;D, Spring House  Pennsylvania USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Roland E.","family":"Knoblauch","sequence":"additional","affiliation":[{"name":"Janssen R&amp;D, Spring House  Pennsylvania USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8787-5587","authenticated-orcid":false,"given":"Hidetoshi","family":"Hayashi","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology Kindai University Faculty of Medicine  Osaka Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2025,9,8]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.21037\/tlcr.2016.06.07"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1111\/cas.14368"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0247620"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.cllc.2021.04.009"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jtho.2021.08.532"},{"key":"e_1_2_10_7_1","unstructured":"The Japan Lung Cancer Society \u201cLung Cancer Treatment Guidelines 2022 Edition. Stage IV Non\u2010Small Cell Lung Cancer \u201d (2024) https:\/\/www.haigan.gr.jp\/guideline\/2022\/1\/2\/220102070100.html#7\u20101\u20101."},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.1158\/0008\u20105472.Can\u201015\u20102833"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.1158\/1535\u20107163.Mct\u201020\u20100071"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.1158\/2159\u20108290.Cd\u201020\u20100116"},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ccell.2015.10.012"},{"key":"e_1_2_10_12_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2306441"},{"key":"e_1_2_10_13_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.lungcan.2018.11.005"},{"key":"e_1_2_10_14_1","doi-asserted-by":"publisher","DOI":"10.1002\/1878\u20100261.13327"},{"key":"e_1_2_10_15_1","doi-asserted-by":"publisher","DOI":"10.21037\/tlcr.2020.03.09"}],"container-title":["Cancer Science"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/cas.70180","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,11,6]],"date-time":"2025-11-06T10:40:11Z","timestamp":1762425611000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/cas.70180"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,9,8]]},"references-count":14,"journal-issue":{"issue":"11","published-print":{"date-parts":[[2025,11]]}},"alternative-id":["10.1111\/cas.70180"],"URL":"https:\/\/doi.org\/10.1111\/cas.70180","archive":["Portico"],"relation":{},"ISSN":["1347-9032","1349-7006"],"issn-type":[{"type":"print","value":"1347-9032"},{"type":"electronic","value":"1349-7006"}],"subject":[],"published":{"date-parts":[[2025,9,8]]},"assertion":[{"value":"2025-07-17","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-08-17","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-09-08","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}