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Repotrectinib in ROS1 Fusion-Positive Non-Small-Cell Lung Cancer
DC Field | Value | Language |
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dc.contributor.author | 조병철 | - |
dc.date.accessioned | 2024-05-23T03:29:09Z | - |
dc.date.available | 2024-05-23T03:29:09Z | - |
dc.date.issued | 2024-01 | - |
dc.identifier.issn | 0028-4793 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/199240 | - |
dc.description.abstract | BACKGROUND: The early-generation ROS1 tyrosine kinase inhibitors (TKIs) that are approved for the treatment of ROS1 fusion-positive non-small-cell lung cancer (NSCLC) have antitumor activity, but resistance develops in tumors, and intracranial activity is suboptimal. Repotrectinib is a next-generation ROS1 TKI with preclinical activity against ROS1 fusion-positive cancers, including those with resistance mutations such as ROS1 G2032R. METHODS: In this registrational phase 1-2 trial, we assessed the efficacy and safety of repotrectinib in patients with advanced solid tumors, including ROS1 fusion-positive NSCLC. The primary efficacy end point in the phase 2 trial was confirmed objective response; efficacy analyses included patients from phase 1 and phase 2. Duration of response, progression-free survival, and safety were secondary end points in phase 2. RESULTS: On the basis of results from the phase 1 trial, the recommended phase 2 dose of repotrectinib was 160 mg daily for 14 days, followed by 160 mg twice daily. Response occurred in 56 of the 71 patients (79%; 95% confidence interval [CI], 68 to 88) with ROS1 fusion-positive NSCLC who had not previously received a ROS1 TKI; the median duration of response was 34.1 months (95% CI, 25.6 to could not be estimated), and median progression-free survival was 35.7 months (95% CI, 27.4 to could not be estimated). Response occurred in 21 of the 56 patients (38%; 95% CI, 25 to 52) with ROS1 fusion-positive NSCLC who had previously received one ROS1 TKI and had never received chemotherapy; the median duration of response was 14.8 months (95% CI, 7.6 to could not be estimated), and median progression-free survival was 9.0 months (95% CI, 6.8 to 19.6). Ten of the 17 patients (59%; 95% CI, 33 to 82) with the ROS1 G2032R mutation had a response. A total of 426 patients received the phase 2 dose; the most common treatment-related adverse events were dizziness (in 58% of the patients), dysgeusia (in 50%), and paresthesia (in 30%), and 3% discontinued repotrectinib owing to treatment-related adverse events. CONCLUSIONS: Repotrectinib had durable clinical activity in patients with ROS1 fusion-positive NSCLC, regardless of whether they had previously received a ROS1 TKI. Adverse events were mainly of low grade and compatible with long-term administration. (Funded by Turning Point Therapeutics, a wholly owned subsidiary of Bristol Myers Squibb; TRIDENT-1 ClinicalTrials.gov number, NCT03093116.). Copyright © 2024 Massachusetts Medical Society. | - |
dc.description.statementOfResponsibility | restriction | - |
dc.language | English | - |
dc.publisher | Massachusetts Medical Society | - |
dc.relation.isPartOf | NEW ENGLAND JOURNAL OF MEDICINE | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.subject.MESH | Antineoplastic Agents* / therapeutic use | - |
dc.subject.MESH | Carcinoma, Non-Small-Cell Lung* / drug therapy | - |
dc.subject.MESH | Carcinoma, Non-Small-Cell Lung* / genetics | - |
dc.subject.MESH | Humans | - |
dc.subject.MESH | Lung Neoplasms* / drug therapy | - |
dc.subject.MESH | Lung Neoplasms* / genetics | - |
dc.subject.MESH | Protein-Tyrosine Kinases* / antagonists & inhibitors | - |
dc.subject.MESH | Protein-Tyrosine Kinases* / genetics | - |
dc.subject.MESH | Proto-Oncogene Proteins / antagonists & inhibitors | - |
dc.subject.MESH | Proto-Oncogene Proteins / genetics | - |
dc.subject.MESH | Treatment Outcome | - |
dc.title | Repotrectinib in ROS1 Fusion-Positive Non-Small-Cell Lung Cancer | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Internal Medicine (내과학교실) | - |
dc.contributor.googleauthor | Alexander Drilon | - |
dc.contributor.googleauthor | D Ross Camidge | - |
dc.contributor.googleauthor | Jessica J Lin | - |
dc.contributor.googleauthor | Sang-We Kim | - |
dc.contributor.googleauthor | Benjamin J Solomon | - |
dc.contributor.googleauthor | Rafal Dziadziuszko | - |
dc.contributor.googleauthor | Benjamin Besse | - |
dc.contributor.googleauthor | Koichi Goto | - |
dc.contributor.googleauthor | Adrianus Johannes de Langen | - |
dc.contributor.googleauthor | Jürgen Wolf | - |
dc.contributor.googleauthor | Ki Hyeong Lee | - |
dc.contributor.googleauthor | Sanjay Popat | - |
dc.contributor.googleauthor | Christoph Springfeld | - |
dc.contributor.googleauthor | Misako Nagasaka | - |
dc.contributor.googleauthor | Enriqueta Felip | - |
dc.contributor.googleauthor | Nong Yang | - |
dc.contributor.googleauthor | Vamsidhar Velcheti | - |
dc.contributor.googleauthor | Shun Lu | - |
dc.contributor.googleauthor | Steven Kao | - |
dc.contributor.googleauthor | Christophe Dooms | - |
dc.contributor.googleauthor | Matthew G Krebs | - |
dc.contributor.googleauthor | Wenxiu Yao | - |
dc.contributor.googleauthor | Muhammad Shaalan Beg | - |
dc.contributor.googleauthor | Xiufeng Hu | - |
dc.contributor.googleauthor | Denis Moro-Sibilot | - |
dc.contributor.googleauthor | Parneet Cheema | - |
dc.contributor.googleauthor | Shanna Stopatschinskaja | - |
dc.contributor.googleauthor | Minal Mehta | - |
dc.contributor.googleauthor | Denise Trone | - |
dc.contributor.googleauthor | Armin Graber | - |
dc.contributor.googleauthor | Gregory Sims | - |
dc.contributor.googleauthor | Yong Yuan | - |
dc.contributor.googleauthor | Byoung Chul Cho | - |
dc.identifier.doi | 10.1056/NEJMoa2302299 | - |
dc.contributor.localId | A03822 | - |
dc.relation.journalcode | J02371 | - |
dc.identifier.eissn | 1533-4406 | - |
dc.identifier.pmid | 38197815 | - |
dc.identifier.url | https://www.nejm.org/doi/10.1056/NEJMoa2302299 | - |
dc.contributor.alternativeName | Cho, Byoung Chul | - |
dc.contributor.affiliatedAuthor | 조병철 | - |
dc.citation.volume | 390 | - |
dc.citation.number | 2 | - |
dc.citation.startPage | 118 | - |
dc.citation.endPage | 131 | - |
dc.identifier.bibliographicCitation | NEW ENGLAND JOURNAL OF MEDICINE, Vol.390(2) : 118-131, 2024-01 | - |
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