Found 3 Presentations For Request "futibatinib"
54P - Efficacy and safety of futibatinib in intrahepatic cholangiocarcinoma (iCCA) harboring FGFR2 fusions/other rearrangements: Subgroup analyses of a phase II study (FOENIX-CCA2)
- John Bridgewater (London, United Kingdom)
Abstract
Background
Methods
Pts enrolled had locally advanced/metastatic iCCA with
Results
Interim data for 67 pts (58% female; median age 57 y) with ≥6 mo of follow-up are reported. Pts had CR, complete response; PD, disease progression; PR, partial response; SD, stable disease. aTwo mutations in
Comutation Patients, n CR PR SD PD 0 0 3 0 2 1 0 2 1 0 2 1 1 0 3 2 3 3 0 0 1 2 3 0 PI3K 0 1 3 0 1 3
Conclusions
These interim data demonstrate manageable AEs and efficacy of futibatinib in iCCA with
Clinical trial identification
NCT02052778; EudraCT: 2013-004810-16.
Editorial acknowledgement
Professional medical writing and editorial assistance were provided by Ashfield Healthcare Communications (Lyndhurst, NJ, USA) and funded by Taiho Oncology, Inc.
Legal entity responsible for the study
Taiho Oncology, Inc.
Funding
Taiho Oncology, Inc.
Disclosure
J. Bridgewater: Advisory/Consultancy: Taiho. F. Meric-Bernstam: Advisory/Consultancy: PACT Pharma, Inflection Biosciences, Pieris Pharmaceuticals, Clearlight Diagnostics, DarwinHealth; Advisory/Consultancy: Samsung Bioepis, Spectrum Biotech, Aduro Biotech, OrigiMed; Advisory/Consultancy: Mersana, Silverback Therapeutics, Immunomedics, IBM Watson Health; Research grant/Funding (self): Guradant Health, Daiichi Sankyo, GlaxoSmithKline; Speaker Bureau/Expert testimony: Chugai Pharma; Travel/Accommodation/Expenses: Beth Israel Deaconess Medical Center; Advisory/Consultancy, Research grant/Funding (self), Travel/Accommodation/Expenses: Seattle Genetics; Honoraria (self): Sumitomo Group, Dialectica; Research grant/Funding (self): Novartis, AstraZeneca, Calithera Biosciences, Bayer, Aileron Therapeutics, PUMA Biotechnology, CytomX Therapeutics; Advisory/Consultancy, Research grant/Funding (self): Genentech, Debiopharm, eFFECTOR Therapeutics; Research grant/Funding (self), Travel/Accommodation/Expenses: Taiho Pharmaceutical; Research grant/Funding (self): Jounce Therapeutics, Zymeworks, Curis, Pfizer, Abbvie, Boehringer Ingelheim. A. Hollebecque: Honoraria (self), Research grant/Funding (self), Travel/Accommodation/Expenses: Incyte; Honoraria (self): Amgen; Travel/Accommodation/Expenses: Servier; Honoraria (self): Merck Serono; Travel/Accommodation/Expenses: Lilly; Honoraria (self): Eisai. J.W. Valle: Advisory/Consultancy: AstraZeneca, Merck, Delcath Systems, Agios; Advisory/Consultancy: PCI Biotech, Incyte, Keocyt, QED Therapeutics, Pieris Pharmaceuticals, Genoscience Pharma; Advisory/Consultancy: Mundipharma EDO GmbH, Wren Laboratories, Nucana, Servier, Debiopharm Group; Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Nucana; Advisory/Consultancy, Speaker Bureau/Expert testimony: Imaging Equipment Limited; Travel/Accommodation/Expenses: Celgene; Advisory/Consultancy, Travel/Accommodation/Expenses: Pfizer; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony: Ipsen; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (self): Novartis. C. Morizane: Advisory/Consultancy: Abbvie; Honoraria (self), Advisory/Consultancy: Novartis, Taiho Pharmaceutical,; Honoraria (self): Teijin Pharma, Merck Sharp & Dohme; Honoraria (self), Research grant/Funding (self): Eisai; Honoraria (self), Advisory/Consultancy, Research grant/Funding (self): Yakult Honsha; Research grant/Funding (self): ONO Pharmaceutical, Taiho Pharmaceutical, J-Pharma, AstraZeneca, Merck. T. Karasic: Research grant/Funding (self): Syndax; Research grant/Funding (self): Taiho Pharmaceutical; Research grant/Funding (self): Celgene; Research grant/Funding (self): H3 Biomedicine; Research grant/Funding (self): Bristol-Myers Squibb; Research grant/Funding (self): Lilly; Research grant/Funding (self): Sirtex Medical. J. Furuse: Honoraria (self), Advisory/Consultancy, Research grant/Funding (self): Taiho Pharmaceutical; Research grant/Funding (self): Ono Pharmaceutical, Merck Sharp & Dohme, Sumitomo Dainippon, J-Pharma, Yakult Honsha, AstraZeneca, Daiichi Sankyo, Eisai, Bayer, Pfizer, NanoCarrier, Kyowa Hakko Kirin, Taiho Pharmaceutical, Chugai Pharma, Sanofi, Takeda, Mochida Pharmaceutical, Astellas; Honoraria (self): Eisai, Bayer Yakuhin, Taiho Pharmaceutical, Ono Pharmaceutical, Novartis, Yakult Honsha, Teijin pharma, Shionogi, EA pharma, Eli Lilly Japan, Takeda, Chugai Pharma, Mochida Pharmaceutical, Nihon Servier, Sanofi, Fujifilm Toyama Chemical, Nobel pharma, Pfi. R.K. Kelley: Research grant/Funding (institution): Taiho, Novartis, QED, Partner Therapeutics, Exelixis, EMD Serono, Eli Lilly, Bayer, Adaptimmune; Advisory/Consultancy, Research grant/Funding (institution): Agios, AstraZeneca, BMS, Merck; Travel/Accommodation/Expenses: Ipsen; Honoraria (self), Advisory/Consultancy: Genentech/Roche; Advisory/Consultancy: Gilead. P. Cassier: Honoraria (institution): Taiho; Honoraria (self), Travel/Accommodation/Expenses: AstraZeneca; Honoraria (institution): Abbvie; Honoraria (institution): Bayer; Honoraria (institution): BMS; Honoraria (self), Honoraria (institution): Blueprint; Honoraria (institution): GlaxoSmithKline; Honoraria (institution): Janssen; Honoraria (institution): Lilly; Honoraria (self), Honoraria (institution), Research grant/Funding (institution), Travel/Accommodation/Expenses: Novartis; Honoraria (self), Honoraria (institution): Roche/Genentech. H-J. Klümpen: Research grant/Funding (institution): Bayer; Advisory/Consultancy: Ipsen. N. Uboha: Advisory/Consultancy, Research grant/Funding (self): Taiho Inc; Advisory/Consultancy, Research grant/Funding (self): AstraZeneca; Advisory/Consultancy, Research grant/Funding (self): Eli Lilly; Advisory/Consultancy: Incyte; Advisory/Consultancy, Research grant/Funding (self): EMD Serono; Advisory/Consultancy, Research grant/Funding (self): Ipsen. E. Mitchell: Advisory/Consultancy, Research grant/Funding (institution): Exilixis; Research grant/Funding (institution): Genentech; Advisory/Consultancy: BMS; Advisory/Consultancy: Merck; Advisory/Consultancy: Novartis. Y. He: Full/Part-time employment: Taiho Oncology. K. Benhadji: Shareholder/Stockholder/Stock options, Full/Part-time employment: Lilly; Full/Part-time employment: Taiho Oncology. L. Goyal: Advisory/Consultancy, Travel/Accommodation/Expenses: Debiopharm Group; Advisory/Consultancy: Alentis Therapeutics; Advisory/Consultancy: QED Therapeutics; Advisory/Consultancy: H3 Biomedicine; Advisory/Consultancy: AstraZeneca; Advisory/Consultancy: Klus Pharma; Advisory/Consultancy: Agios; Advisory/Consultancy, Research grant/Funding (self), Travel/Accommodation/Expenses: Taiho Pharmaceutical. All other authors have declared no conflicts of interest.
58P - Quality of life (QoL) outcomes with futibatinib treatment in FOENIX-CCA2 - A phase II study in patients (pts) with intrahepatic cholangiocarcinoma (iCCA) harboring FGFR2 gene fusions/rearrangements
- Juan W. Valle (Manchester, United Kingdom)
Abstract
Background
Cancer treatment can produce AEs that result in a reduced QoL. Futibatinib, a highly selective irreversible FGFR1–4 inhibitor, demonstrated an objective response rate (ORR) of 37.3% and median 8.3-mo duration of response in the interim analysis of FOENIX-CCA2, a mutlicenter phase II trial of pts with advanced, refractory iCCA harboring an
Methods
Pts enrolled into FOENIX-CCA2 (NCT02052778), had locally advanced/metastatic unresectable iCCA and received oral futibatinib 20 mg once daily (QD) until disease progression/intolerance. PRO measures included EORTC-QLQ-C30 (5 functional and 9 physical measures) and EQ-5D-3L (utility index and 5 dimensions: anxiety/depression, mobility, pain/discomfort, self-care, and usual activity). PROs were collected at screening, cycles 2 and 4, every 3 cycles after cycle 4 and at the end of treatment. Change in mean score from BL was assessed using predefined clinically meaningful thresholds for each time point with ≥19 observations (through cycle 13).
Results
Sixty-seven of 103 enrolled pts had ≥6 months of follow-up and 57 (85.1%) had PRO completion data at BL and ≥1 assessment. EORTC mean global health status score was high at BL (68.7) and maintained through cycle 13 (70.8), a trend observed across all EORTC measures. The only clinically meaningful changes (≥10-point changes) in this timeframe were for constipation symptoms at cycles 2 and 4 (worsened +12.4 and +10.7, respectively) and dyspnea at cycle 10 (improved -12.2). Mean EQ-5D-3L index scores improved from 70.9 at BL to 79.1 at cycle 13 (approximately 273 days on treatment).
Conclusions
Overall, the interim PROs from FOENIX-CCA2 were encouraging. These data suggest that despite the occurrence of TRAEs, a 20-mg-QD dose of futibatinib in pts with iCCA provides a promising clinical response without adversely impacting QoL.
Clinical trial identification
NCT02052778; EudraCT: 2013-004810-16.
Editorial acknowledgement
Professional medical writing and editorial assistance were provided by Ashfield Healthcare Communications (Lyndhurst, NJ, USA) and funded by Taiho Oncology, Inc.
Legal entity responsible for the study
Taiho Oncology, Inc.
Funding
Taiho Oncology, Inc.
Disclosure
J.W. Valle: Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony: Ipsen; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (self): Novartis; Advisory/Consultancy: AstraZeneca; Advisory/Consultancy: Merck; Advisory/Consultancy: Delcath Systems; Advisory/Consultancy: Agios; Advisory/Consultancy, Travel/Accommodation/Expenses: Pfizer; Advisory/Consultancy: PCI Biotech; Advisory/Consultancy: Incyte; Advisory/Consultancy: Keocyt; Advisory/Consultancy: QED Therapeutics; Advisory/Consultancy: Pieris Pharmaceuticals; Advisory/Consultancy: Genoscience Pharma; Advisory/Consultancy: Mundipharma EDO GmbH; Advisory/Consultancy: Wren Laboratories; Advisory/Consultancy, Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Nucana; Advisory/Consultancy: Servier; Advisory/Consultancy, Speaker Bureau/Expert testimony: Imaging Equipment Limited; Travel/Accommodation/Expenses: Celgene. A. Hollebecque: Honoraria (self), Research grant/Funding (self), Travel/Accommodation/Expenses: Incyte; Honoraria (self): Amgen; Travel/Accommodation/Expenses: Servier; Honoraria (self): Merck Serono; Travel/Accommodation/Expenses: Lilly; Honoraria (self): Eisai .J. Furuse: Advisory/Consultancy, Travel/Accommodation/Expenses: Debiopharm Group; Advisory/Consultancy: Alentis Therapeutics; Advisory/Consultancy: QED Therapeutics; Advisory/Consultancy: H3 Biomedicine; Advisory/Consultancy: AstraZeneca; Advisory/Consultancy: Klus Pharma; Advisory/Consultancy: Agios; Advisory/Consultancy, Research grant/Funding (self), Travel/Accommodation/Expenses: Taiho Pharmaceutical Co.F. Meric-Bernstam: Advisory/Consultancy, Research grant/Funding (institution): Genentech; Advisory/Consultancy: Inflection Biosciences; Advisory/Consultancy: Pieris Pharmaceuticals; Advisory/Consultancy: Clearlight Diagnostics; Advisory/Consultancy: DarwinHealth; Advisory/Consultancy: Samsung Bioepis; Advisory/Consultancy: Spectrum Pharmaceuticals; Advisory/Consultancy: Aduro Biotech; Advisory/Consultancy: Origimed; Advisory/Consultancy: Xencor; Advisory/Consultancy, Research grant/Funding (institution): Debiopharm Group; Advisory/Consultancy: Mersana; Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Seattle Genetics; Advisory/Consultancy: Silverback Therapeutics; Advisory/Consultancy: Immunomedics; Advisory/Consultancy: IBM Watson Health; Advisory/Consultancy: Roche; Advisory/Consultancy: PACT Pharma; Advisory/Consultancy, Research grant/Funding (institution): eFFECTOR Therapeutics; Research grant/Funding (institution), Travel/Accommodation/Expenses: Taiho Pharmaceutical; Speaker Bureau/Expert testimony: Chugai Pharma; Travel/Accommodation/Expenses: Beth Israel Deaconess Medical Center; Honoraria (self): Sumitomo Group; Honoraria (self): Dialectica; Research grant/Funding (institution): Novartis; Research grant/Funding (institution): AstraZeneca; Research grant/Funding (institution): Calithera Biosciences; Research grant/Funding (institution): Bayer; Research grant/Funding (institution): Aileron Therapeutics; Research grant/Funding (institution): PUMA Biotechnology, CytomX Therapeutics, Jounce Therapeutics, Zymeworks, Curis, Pfizer, Abbvie, Boehringer Ingelheim, Guardant Health, Daiichi Sankyo. R. Morlock: Advisory/Consultancy: Taiho Oncology; Advisory/Consultancy: Johnson and Johnson; Advisory/Consultancy: Heron; Advisory/Consultancy: Evofem; Advisory/Consultancy: Horizon Therapeutics. Y. He: Full/Part-time employment: Taiho Oncology. K. Benhadji: Shareholder/Stockholder/Stock options, Full/Part-time employment: Lilly; Full/Part-time employment: Taiho Oncology. J. Bridgewater: Advisory/Consultancy: Taiho. All other authors have declared no conflicts of interest.
544P - Phase I study of the irreversible FGFR inhibitor (i) futibatinib (FBN; TAS-120) in Japanese patients (pts) with advanced (adv) solid tumours
- Chigusa Morizane (Chuo-ku, Japan)
Abstract
Background
The FGFRi FBN showed tolerability and preliminary efficacy in a phase I dose-escalation (DE)/expansion (EX) study conducted in primarily Caucasian pts with adv solid tumours (NCT02052778), and 20 mg once-daily (QD) FBN was established as the recommended phase II dose (RP2D). Here, we report results from a Japanese phase I DE/EX study of FBN in adv solid tumours.
Methods
In DE, pts received 8–160 mg FBN thrice weekly (TIW; accelerated titration or standard 3+3 design), or 16 and 20 mg QD. The primary objective was safety and maximum tolerated dose (MTD) evaluation; secondary were pharmacokinetics (PK) and preliminary efficacy. The EX phase included pts with
Results
Sixty-three pts were enrolled in 8 TIW (DE; 29 pts, EX; 11 pts) and 2 QD cohorts (DE; 10 pts, EX; 13 pts). Pts had colorectal (16%), esophageal (13%), gastric (13%), or biliary tract cancer (11%), and 52% had tumors with
Conclusions
FBN showed manageable safety and preliminary efficacy in Japanese pts with adv solid tumors; RP2D (20 mg QD) in this study was consistent with prior results. Phase 2/3 studies in cholangiocarcinoma (NCT02052778; NCT04093362), gastric (NCT04189445) and breast tumours (NCT04024436) are ongoing.
Clinical trial identification
JapicCTI-142552.
Legal entity responsible for the study
Taiho Pharmaceutical Co., Ltd.
Funding
Taiho Pharmaceutical Co., Ltd.
Disclosure
C. Morizane: Honoraria (self), Research grant/Funding (institution): Taiho Pharmaceutical; Honoraria (self): Novartis; Honoraria (self), Research grant/Funding (institution): Yakult Honsha; Honoraria (self): Teijin Pharma; Honoraria (self), Research grant/Funding (institution): Eisai; Honoraria (self), Advisory/Consultancy: MSD K.K.; Research grant/Funding (institution): ONO Pharmaceutical; Research grant/Funding (institution): J-Pharma; Research grant/Funding (institution): AstraZeneca; Research grant/Funding (institution): Merck biopharma; Advisory/Consultancy: AbbVie. T. Kojima: Advisory/Consultancy, Research grant/Funding (institution): Ono; Advisory/Consultancy, Research grant/Funding (institution): MSD; Research grant/Funding (institution): Shionogi; Research grant/Funding (institution): Astellas Amgen; Advisory/Consultancy: Astellas; Research grant/Funding (institution): Chugai; Advisory/Consultancy: Oncolys; Research grant/Funding (institution): Parexel; Research grant/Funding (institution): Merck Serono; Advisory/Consultancy: Merck Biopharma; Advisory/Consultancy: Bristol-Myers Squibb. Y. Kuboki: Honoraria (self), Research grant/Funding (institution): Taiho; Honoraria (self), Research grant/Funding (institution): ONO; Honoraria (self): Bayer; Honoraria (self): Sanofi; Honoraria (self): Lilly; Advisory/Consultancy, Research grant/Funding (institution): Takeda; Advisory/Consultancy, Research grant/Funding (institution): Boehringer Ingelheim; Research grant/Funding (institution): AstraZeneca; Research grant/Funding (institution): Daiichi Sankyo; Research grant/Funding (institution): Incyte; Research grant/Funding (institution): Amgen; Research grant/Funding (institution): Chugai; Research grant/Funding (institution): GSK. H. Bando: Honoraria (self): Taiho Parmaceutical; Honoraria (self): Eli Lilly Japan. N. Matsubara: Honoraria (self), Research grant/Funding (institution): Chugai Pharmaceutical Co.Ltd.; Honoraria (self), Research grant/Funding (institution): MSD K.K.,; Honoraria (self), Research grant/Funding (institution): Bayer Yakuhin, Ltd.,; Honoraria (self): Sanofi K.K.; Honoraria (self), Research grant/Funding (institution): Janssen Pharmaceutical K.K.; Research grant/Funding (institution): Astellas Pharma Inc.,; Research grant/Funding (institution): AstraZeneca K.K.; Research grant/Funding (institution): TAIHO Phamaceutical Co.,Ltd.; Research grant/Funding (institution): Pfizer Japan Inc.. K. Shitara: Honoraria (self), Advisory/Consultancy: Novartis; Honoraria (self), Advisory/Consultancy: AbbVie ; Honoraria (self): Yakult; Advisory/Consultancy, Research grant/Funding (institution): Astellas Pharma; Advisory/Consultancy, Research grant/Funding (institution): Lilly; Advisory/Consultancy: Bristol-Myers Squibb; Advisory/Consultancy: Takeda; Advisory/Consultancy: Pfizer; Advisory/Consultancy, Research grant/Funding (institution): Ono Pharmaceutical; Advisory/Consultancy, Research grant/Funding (institution): Taiho Pharmaceutical; Advisory/Consultancy, Research grant/Funding (institution): MSD; Advisory/Consultancy: GlaxoSmithKline; Research grant/Funding (institution): Chugai Pharm; Research grant/Funding (institution): Medi Science; Research grant/Funding (institution): Daiichi Sankyo; Research grant/Funding (institution): Dainippon Sumitomo Pharma. K. Yoh: Honoraria (self), Research grant/Funding (institution): Taiho Pharmaceutical; Honoraria (self), Research grant/Funding (institution): Chugai Pharma; Honoraria (self), Research grant/Funding (institution): AstraZeneca; Honoraria (self), Research grant/Funding (institution): Lilly; Honoraria (self), Research grant/Funding (institution): Ono Pharmaceutical; Honoraria (self), Research grant/Funding (institution): Novartis; Honoraria (self), Research grant/Funding (institution): MSD; Honoraria (self), Research grant/Funding (institution): Bristol-Myers Squibb; Honoraria (self), Research grant/Funding (institution): Daiichi Sankyo; Honoraria (self): Boehringer Ingelheim; Honoraria (self): Kyowa Kirin; Research grant/Funding (institution): Bayer; Research grant/Funding (institution): Pfizer; Research grant/Funding (institution): Takeda. H. Hirai: Full/Part-time employment: Taiho. T. Kato: Honoraria (self), Research grant/Funding institution): Taiho. T. Doi: Honoraria (self), Research grant/Funding (institution): BMS; Honoraria (self): Astellas; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): AbbVie; Honoraria (self): Ono; Honoraria (self): Oncolys Biopharma; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Taiho; Advisory/Consultancy: Amgen; Advisory/Consultancy, Research grant/Funding (institution): Sumitomo Dainippon; Advisory/Consultancy: Rakuten Medical; Advisory/Consultancy, Research grant/Funding (institution): Daiichi Sankyo; Advisory/Consultancy: Takeda; Advisory/Consultancy: Bayer; Advisory/Consultancy, Research grant/Funding (institution): Novartis; Advisory/Consultancy, Research grant/Funding (institution): Boehringer Ingelheim; Research grant/Funding (institution): MSD; Research grant/Funding (institution): Merck Serono; Research grant/Funding (institution): Lilly; Research grant/Funding (institution): Eisai; Research grant/Funding (institution): Kyowa Hakko Kirin; Research grant/Funding (institution): IQVIA; Research grant/Funding (institution): Pfizer.