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Found 3 Presentations For Request "futibatinib"

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Poster Display session

54P - Efficacy and safety of futibatinib in intrahepatic cholangiocarcinoma (iCCA) harboring FGFR2 fusions/other rearrangements: Subgroup analyses of a phase II study (FOENIX-CCA2)

Presentation Number
54P
Speakers
  • John Bridgewater (London, United Kingdom)
Date
17.09.2020

Abstract

Background

FGFR2 fusions occur in 10–20% of pts with iCCA and comutations in tumor suppressor genes may be prognostic. FOENIX-CCA2 is a study of futibatinib (a highly selective irreversible FGFR1–4 inhibitor) in pts with iCCA and FGFR2 fusions/other rearrangements.

Methods

Pts enrolled had locally advanced/metastatic iCCA with FGFR2 fusions/other rearrangements, progressive disease (PD) after ≥1 systemic therapy (tx), no prior FGFR inhibitor tx, and ECOG PS 0/1. Pts received oral futibatinib 20 mg 1x/day until PD/intolerance. Objective response rate (ORR; independent review) was the primary endpoint and duration of response (DOR), PFS and safety were secondary endpoints. Subanalyses by pt characteristic, fusion, comutation and prognostic factor were performed.

Results

Interim data for 67 pts (58% female; median age 57 y) with ≥6 mo of follow-up are reported. Pts had FGFR2 fusions (82%) or rearrangements (18%). The most frequent fusion was FGFR2-BICC1 (n=15). ORR was 37.3%, median DOR 8.3 mo, and disease control rate 82%. In pts with confirmed FGFR2 alterations, ORR was 36.2% (21/58 fusions) and 44.4% (4/9 rearrangements). ORR was 33.3% in pts with FGFR2-BICC1. Best overall response in pts with comutations of interest is shown in the table below. All baseline characteristic subgroups (eg, age, gender, prior tx) had responding pts, including pts aged ≥65 y (ORR=57%; 8/14). Higher phosphate levels trended in responders vs nonresponders. Grade ≥3 treatment-related hyperphosphatemia resolved in a median of 6 d. Management of special interest AEs will be presented.

Comutation Patients, n
CR PR SD PD FGFR2 fusion FGFR2 rearrangement
BAP1 (n=3) 0 0 3 0 2 1
IDH1 (n=3) 0 2 1 0 2 1
TP53 (n=6) 1 0 3 2 3 3
PBRM1 (n=3) 0 0 1 2 3 0
PI3K genes a (n=4) 0 1 3 0 1 3

CR, complete response; PD, disease progression; PR, partial response; SD, stable disease. aTwo mutations in PIK3A, 1 in PIK3B, and 1 in PIK3R1.

Conclusions

These interim data demonstrate manageable AEs and efficacy of futibatinib in iCCA with FGFR2 fusions/other rearrangements. Responses were observed across pt subgroups, including those with common FGFR2 fusions, comutations, and poor prognostic factors.

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.

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Poster Display session

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

Presentation Number
58P
Speakers
  • Juan W. Valle (Manchester, United Kingdom)
Date
17.09.2020

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 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.

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Poster Display session

544P - Phase I study of the irreversible FGFR inhibitor (i) futibatinib (FBN; TAS-120) in Japanese patients (pts) with advanced (adv) solid tumours

Presentation Number
544P
Speakers
  • Chigusa Morizane (Chuo-ku, Japan)
Date
17.09.2020

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 FGF/FGFR abnormalities receiving FBN at doses < MTD.

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 FGF/FGFR aberrations. No DLTs were observed in the study; MTD was not reached with TIW dosing. QD enrollment was based on prior phase I data and 20 mg QD was determined as the RP2D. Overall, 5% of pts experienced grade (gr) ≥3 treatment-related adverse events (TRAEs). Most common TRAEs (all gr; gr ≥3) were hyperphosphatemia (89%; 0), decreased appetite (22%; 0), nausea (19%; 0), stomatitis (14%; 2%), retinal detachment (13%; 0), and elevated AST (11%; 3%). TRAEs led to dose reductions, interruptions, and discontinuation in 24%, 48%, and 0% of pts, respectively. The PK profile of 20 mg QD FBN (mean Cmax, 253 ng/mL; AUC0-last, 977ng·h/mL; median Tmax, 2.00 h; apparent T1/2, 2.18 h) was similar to that observed in Caucasian pts. Efficacy assessment is ongoing; at data cutoff (July 4, 2019), partial responses were observed in pts with gastric (n=2; tumor shrinkages of 59% and 70%) and breast cancer (n=1; tumor shrinkage, 37%) harboring FGFR2 amplifications.

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.

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