Abstract 58P
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 FGFR2 fusion/rearrangement; grade ≥3 treatment-related AEs (TRAEs) occurred in 57% of pts (most commonly, hyperphosphatemia [26.9%]). Change in pt-reported outcomes (PROs) from baseline (BL) for the interim data of the phase II trial are presented here.
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.