10011-CS-2 A Phase II basket trial evaluating the efficacy of tasurgratinib in patients with advanced solid tumors with fibroblast growth factor receptor (FGFR) gene alteration (FORTUNE study)
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Le résumé fourni par la source
Abstract Background Tasurgratinib is orally available selective FGFR1-3 tyrosine kinase inhibitor approved in Japan for biliary tract cancer with FGFR2 fusions or rearrangements. We previously identified highly sensitive FGFR mutations to tasurgratinib using a high-throughput functional evaluation method (MANO method). We conducted a multicenter, single-arm investigator-initiated phase 2 basket trial to evaluate tasurgratinib in patients (pts) with FGFR alterations. Methods Pts with advanced solid tumors with FGFR gene alterations received tasurgratinib 140 mg QD. Pts were assigned to each group (Group A: FGFR1-3 fusion, Group B: FGFR1-3 mutation sensitive to tasurgratinib by MANO methods, Group C: FGFR1-3 activating mutation not in Group B or FGFR1/2 amplification, Group D: cholangiocarcinoma with FGFR2 fusion pretreated with other FGFR inhibitors). The primary endpoint for Groups A-C was objective response rate (ORR) by independent central review (ICR); Group D was exploratory cohort. Secondary endpoints included ORR by investigator assessment (IA), progression-free survival (PFS), overall survival, and safety. The threshold and expected response rates were 5% and 30%. Target enrollment for Group A, B, C and D were 10 pts, 15 pts, 15 pts and 1-5 pts, respectively. Results From June 2021 to December 2022, 46 pts enrolled and 41 comprised the full analysis set (A:10, B:15, C:15, D:1). Most common primary sites in each group were brain (A), biliary tract (B), and esophagus/stomach (C). ORRs by ICR were: A: 20.0% (90% CI 3.7-50.7, p = 0.0861), B: 20.0% (90% CI 5.7-44.0, p = 0.0362), and C: 6.7% (90% CI 0.3-27.9, p = 0.5367). ORRs by IA were: A: 20.0%, B: 40.0%, C: 13.3%, D: 0.0%. Median PFSs by IA were A: 2.5, B: 7.2, C: 2.2, D: 5.7 months. No new safety signals were observed. Conclusions Primary endpoint was met in Group B. Tasurgratinib demonstrated clinical activity in pts with selected FGFR-mutated tumors. Additional recruitment of pts has been resumed. (jRCT2031210043).
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Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- 10011-CS-2 A Phase II basket trial evaluating the efficacy of tasurgratinib in patients with advanced solid tumors with fibroblast growth factor receptor (FGFR) gene alteration (FORTUNE study)
- Date Crossref
- 01/12/2025
- Éditeur
- Oxford University Press (OUP)
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
Où se fait cette recherche
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Tokai University Department of Neurosurgery pays non établi dans la noticeUniversité ou école supérieure
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Tohoku University Department of Clinical Oncology pays non établi dans la noticeUniversité ou école supérieure
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National Cancer Center Department of Neurosurgery and Neuro-Oncology pays non établi dans la noticeOrganisation à but non lucratif
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Tokai University Hospital pays non établi dans la noticeÉtablissement de santé
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Kyoto University Department of Medical Oncology pays non établi dans la noticeUniversité ou école supérieure
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Kyoto Prefectural University of Medicine pays non établi dans la noticeUniversité ou école supérieure
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Kyushu University Hospital Department of Hematology pays non établi dans la noticeÉtablissement de santé
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Hokkaido University pays non établi dans la noticeUniversité ou école supérieure
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National Clinical Research pays non établi dans la noticeStructure de recherche
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Faculty of Medicine and Graduate School of Medicine Department of Medical Oncology pays non établi dans la noticeUniversité ou école supérieure
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Clinical Research Support Office pays non établi dans la noticeÉtablissement de santé
Department of Neurosurgery — Tokai University, Department of Clinical Oncology — Tohoku University et Department of Neurosurgery and Neuro-Oncology — National Cancer Center, avec 8 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.