{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,12,31]],"date-time":"2025-12-31T00:33:51Z","timestamp":1767141231944,"version":"build-2238731810"},"reference-count":17,"publisher":"Springer Science and Business Media LLC","issue":"12","license":[{"start":{"date-parts":[[2022,8,29]],"date-time":"2022-08-29T00:00:00Z","timestamp":1661731200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2022,8,29]],"date-time":"2022-08-29T00:00:00Z","timestamp":1661731200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"name":"This study was sponsored by Takeda Pharmaceutical Company Limited."}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Int J Clin Oncol"],"published-print":{"date-parts":[[2022,12]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>\n                      We evaluated the safety and efficacy of the anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor (TKI) brigatinib in Japanese patients with TKI-naive\n                      <jats:italic>ALK<\/jats:italic>\n                      -positive non-small cell lung cancer (NSCLC) from the phase 2, open-label, single-arm, multicenter J-ALTA study.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>In the TKI-naive cohort of J-ALTA, the primary end point was independent review committee (IRC)-assessed 12-month progression-free survival (PFS). Secondary end points included objective response rate (ORR), intracranial response, overall survival (OS), and safety.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      The data were cut approximately 12\u00a0months after last patient enrollment. Thirty-two patients with ALK TKI-naive\n                      <jats:italic>ALK<\/jats:italic>\n                      -positive NSCLC were enrolled (median age [range], 60.5 [29\u201385] years; median duration of follow-up, 14.2 [3.2\u201319.3] months; median treatment duration, 13.8 [0.4\u201319.3] months). IRC-assessed 12-month PFS was 93.0% (90% confidence interval (CI) 79.2\u201397.8%); ORR, 96.9% (95% CI 83.8\u201399.9%), 12-month OS, 96.9% (95% CI 79.8\u201399.6%), and median OS was not reached. Of five patients with measurable baseline CNS metastases, two had partial intracranial response. The most common treatment-emergent adverse events were increased blood creatine phosphokinase (81%), hypertension (59%), and diarrhea (47%). Grade\u2009\u2265\u20093 adverse events occurred in 91% of patients; pneumonitis was reported in 3 (9%) patients.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>\n                      In the J-ALTA TKI-naive cohort, brigatinib demonstrated clinically meaningful efficacy consistent with the international phase 3 study. The safety profile in Japanese patients was consistent with previous studies. Brigatinib is an important first-line option for Japanese patients with\n                      <jats:italic>ALK<\/jats:italic>\n                      -positive NSCLC.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Clinical registration<\/jats:title>\n                    <jats:p>NCT03410108<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1007\/s10147-022-02232-7","type":"journal-article","created":{"date-parts":[[2022,8,29]],"date-time":"2022-08-29T06:03:38Z","timestamp":1661753018000},"page":"1828-1838","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":6,"title":["Brigatinib in Japanese patients with tyrosine kinase inhibitor-naive ALK-positive non-small cell lung cancer: first results from the phase 2\u00a0J-ALTA study"],"prefix":"10.1007","volume":"27","clinical-trial-number":[{"clinical-trial-number":"nct03410108","registry":"10.18810\/clinical-trials-gov"}],"author":[{"given":"Shunichi","family":"Sugawara","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Masashi","family":"Kondo","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Toshihide","family":"Yokoyama","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Toru","family":"Kumagai","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Makoto","family":"Nishio","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Koichi","family":"Goto","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kazuhiko","family":"Nakagawa","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Takashi","family":"Seto","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nobuyuki","family":"Yamamoto","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kentarou","family":"Kudou","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Takayuki","family":"Asato","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Pingkuan","family":"Zhang","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6137-073X","authenticated-orcid":false,"given":"Yuichiro","family":"Ohe","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2022,8,29]]},"reference":[{"issue":"10026","key":"2232_CR1","doi-asserted-by":"publisher","first-page":"1415","DOI":"10.1016\/S0140-6736(16)00004-0","volume":"387","author":"F Barlesi","year":"2016","unstructured":"Barlesi F, Mazieres J, Merlio JP et al (2016) Routine molecular profiling of patients with advanced non-small-cell lung cancer: results of a 1-year nationwide programme of the French Cooperative Thoracic Intergroup (IFCT). 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Masashi Kondo: honoraria from Chugai Pharma, Lilly, Pfizer, AstraZeneca, Ono Pharmaceutical, Bristol-Myers Squibb, and MSD KK; consulting\/advisory role for Novartis, Takeda; speakers\u2019 bureau for Chugai Pharma, Lilly, AstraZeneca, Ono Pharmaceutical, Bristol-Myers Squibb, and MSD; research funding (all to institution) from Chugai Pharma, Ono Pharmaceutical, AstraZeneca, MSD, and Takeda. Toshihide Yokoyama: honoraria from AstraZeneca KK, Bristol-Myers Squibb KK, Chugai Pharmaceutical, Nippon Boehringer Ingelheim, Novartis KK, Ono Pharmaceutical, Pfizer, and Nippon Kayaku; research funding (all to institution) from Eli Lilly Japan KK, Merck Sharp and Dohme KK, and Takeda. Toru Kumagai: consulting\/advisory role for Takeda Pharmaceutical Company Limited and Nitto Denko Corporation; speakers\u2019 bureau for Bristol-Myers Squibb KK, Chugai Pharmaceutical Co. Ltd., Eli Lilly Japan KK, AstraZeneca KK, MSD KK, Taiho Pharmaceutical Co. Ltd., Nippon Boehringer lngelheim Co., Ltd., and Novartis Pharma KK; research funding (all to institution) from MSD KK, AstraZeneca KK, Ono Pharmaceutical, Chugai Pharmaceutical Co. Ltd., Eli Lilly Japan KK, Novartis Pharma KK, Parexel International Corporation, Nippon Boehringer lngelheim Co., Ltd., Takeda Pharmaceutical Company Limited., Pfizer Japan Inc., Merck Biopharma Co., Ltd., Taiho Pharmaceutical Co. Ltd., Delta-Fly Pharma, Inc., IQVIA Services Japan KK, AbbVie GK, and Nippon Kayaku Co., Ltd.; other relationship: Pfizer Japan Inc. Makoto Nishio: speaker or member of the advisory boards of AbbVie, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Chugai Pharmaceutical, Eli Lilly, Merck Serono, Merck Sharp and Dohme, Novartis, Ono Pharmaceutical, Pfizer, Sankyo Healthcare, Taiho Pharmaceutical, Takeda, and Teijin Pharma; research support\/grant support from AstraZeneca, Bristol-Myers Squibb, Chugai Pharmaceutical, Eli Lilly, Merck Sharp and Dohme, Novartis, Ono Pharmaceutical, Pfizer, Taiho Pharmaceutical, and Takeda. Koichi Goto: grants and\/or personal fees from Amgen Astellas BioPharma KK, AstraZeneca KK, Boehringer Ingelheim Japan, Bristol-Myers Squibb KK, Chugai Pharmaceutical, Daiichi Sankyo, Eisai, Eli Lilly Japan KK, Guardant Health, Ignyta, Janssen Pharmaceutical, Kyowa Kirin, Loxo Oncology, Medical and Biological Laboratories Co., Merck Serono, Merck Sharp and Dohme, Nippon Kayaku, Novartis KK, Ono Pharmaceutical, Otsuka Pharmaceutical, Pfizer, Sumitomo Dainippon Pharma, Sysmex Corporation, Taiho Pharmaceutical, Takeda, Thermo Fisher Scientific KK, and Xcoo. Kazuhiko Nakagawa: consulting\/advisory role for Kyorin Pharmaceutical and Takeda; grants and\/or personal fees from 3H Clinical Trial, AbbVie, Bayer Yakuhin, Care Net, Clinical Trial Co, CMIC Shift Zero, Eisai, EP-CRSU, EPS Corporation, EPS International, Gritstone Oncology, Icon Japan KK, inVentiv Health Japan, Kissei Pharmaceutical, Kyorin Pharmaceutical, Kyowa Kirin, Linical, Medical Mobile Communications, Medical Review Co, Medicus, Nanzando, Nichi-Iko Pharmaceutical, Nikkei Business Publications, Nippon Kayaku, Otsuka Pharmaceutical, Parexel, Pfizer R&D Japan KK, Reno Medical KK, Roche KK, Shuppan Publishers, Symbio Pharmaceutical, Syneos Health, Taiho Pharmaceutical, Takeda, Thermo Fisher Scientific, Yodosha, and Yomiuri Telecasting. Takashi Seto: grants and\/or personal fees from AbbVie, Astellas Pharma, AstraZeneca, Bayer Yakuhin, Bristol-Myers Squibb, Chugai Pharmaceutical, Daiichi Sankyo, Eli Lilly Japan, Kissei Pharmaceutical, Kyowa Kirin, Loxo Oncology, Merck Biopharma, Merck Sharp and Dohme, Nippon Boehringer Ingelheim, Novartis Pharma, Ono Pharmaceutical, Pfizer Japan, Precision Medicine Asia, Taiho Pharmaceutical, Takeda, and Thermo Fisher Scientific. Nobuyuki Yamamoto: grants and\/or personal fees from AbbVie GK, Amgen, Astellas, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Chugai Pharmaceutical, Daiichi Sankyo, Eisai, Eli Lilly Japan KK, Kyorin Pharmaceutical, Life Technologies Japan Ltd., Merck Biopharma, Merck Sharp and Dohme KK, Nippon Kayaku, Novartis, Ono Pharmaceutical, Pfizer, Shionogi, Taiho Pharmaceutical, Takeda, Terumo, Thermo Fisher Scientific, Toppan Printing, Tosoh, and Tsumura and Co. Kentarou Kudou: Mr. Kudou is an employee of Takeda Pharmaceutical Company Limited. Takayuki Asato: Mr. Asato is an employee of Takeda Pharmaceutical Company Limited. Pingkuan Zhang: Dr. Zhang is an employee of Takeda Development Center Americas, Inc. Yuichiro Ohe: grants and\/or personal fees from AstraZeneca, Amgen, Bristol-Myers Squibb, Boehringer Ingelheim, Celltrion, Chugai Pharmaceutical, Eli Lilly, Janssen, Kissei Pharmaceutical, Kyorin, Ignyta, Merck Sharp and Dohme, Nippon Kayaku, Novartis, Ono Pharmaceutical, Taiho Pharmaceutical, Takeda, and Pfizer.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interests"}}]}}