Found 2 Presentations For Request "Abs: 544P"
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.
1165P - Subgroup analysis by Ki-67 and primary tumour origins of the randomized, placebo-controlled phase III study of surufatinib in advanced well-differentiated extrapancreatic neuroendocrine tumours (SANET-ep)
- Zhiwei Zhou (Guangzhou, China)
Abstract
Background
Surufatinib, a tyrosine kinase inhibitor targeting vascular endothelial growth factor receptors (1,2,3), fibroblast growth factor receptor 1 and colony stimulating factor 1 receptor, has demonstrated superior efficacy in extrapancreatic neuroendocrine tumors (NETs) in a phase III study (SANET-ep, ESMO 2019 Abs. LBA76). The proliferation marker Ki-67 and primary tumor origins are the major prognostic factors in NETs.
Methods
The post-hoc efficacy analysis of surufatinib versus placebo was conducted by Ki-67 subcategory (<3%, 3-10%, >10%) and primary tumor origins (foregut, midgut, hindgut, others or unknown) in patients (pts) with advanced well-differentiated (grade 1 or 2) extrapancreatic NETs. The primary endpoint (progression-free survival [PFS]) and secondary endpoint (objective response rate [ORR]) both by investigator assessment (RECIST1.1) were analyzed.
Results
Median PFS was significantly prolonged with surufatinib compared to placebo in subgroups of Ki-67 3-10% (7.6 vs 4.6 months [mo], hazard ratio [HR] 0.47,
Conclusions
Surufatinib demonstrated clinically significant benefits for pts with advanced well-differentiated extrapancreatic NETs compared to placebo. Results of this exploratory analysis were consistent with those reported for the SANET-ep primary analysis, and improved outcomes were observed across major subgroups.
Clinical trial identification
NCT02588170.
Legal entity responsible for the study
Hutchison MediPharma Limited.
Funding
Hutchison MediPharma Limited.
Disclosure
J. Li, J. He: Full/Part-time employment: Hutchison MediPharma Limited. W. Su: Shareholder/Stockholder/Stock options, Full/Part-time employment: Hutchison MediPharma Limited. All other authors have declared no conflicts of interest.