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ePoster Display

47P - Derazantinib for patients with intrahepatic cholangiocarcinoma harboring FGFR2 fusions/rearrangements: Primary results from the phase II study FIDES-01

Date

16 Sep 2021

Session

ePoster Display

Topics

Cytotoxic Therapy;  Clinical Research;  Targeted Therapy;  Cancer Biology;  Hepatobiliary Cancers

Presenters

Michele Droz Dit Busset

Citation

Annals of Oncology (2021) 32 (suppl_5): S376-S381. 10.1016/annonc/annonc685

Authors

M. Droz Dit Busset1, W. L.Shaib2, K. Mody3, N. Personeni4, N. Damjanov5, W.P. Harris6, F. Bergamo7, G. Brandi8, G. Masi9, T.R. Halfdanarson10, V. Tam11, L.W. Goff12, J. Knox13, A. Hollebecque14, T. Macarulla Mercade15, F. Cantero16, M. Saulay17, S. Braun17, M. Javle18, M. Borad19

Author affiliations

  • 1 Hepatopancreatobiliary And Digestive Surgery, Istituto Nazionale dei Tumori di Milano - Fondazione IRCCS, 20133 - Milan/IT
  • 2 Hematology And Oncology, Emory University School of Medicine, 30322 - Atlanta/US
  • 3 Oncology Medical, Mayo Clinic, 32224 - Jacksonville/US
  • 4 Hematology And Oncology, Istituto Clinico Humanitas, 20089 - Rozzano/IT
  • 5 Medical Oncology, Temple University Cancer Center, 19140-5189 - Philadelphia/US
  • 6 Medicine, University of Washington Medical Center, 98195 - Seattle/US
  • 7 Dipartimento Oncologia 1, IOV - Istituto Oncologico Veneto IRCCS, 35128 - Padova/IT
  • 8 Dipartimento Di Medicina Specialistica, Diagnostica E Sperimentale- Dimes, Policlinico S. Orsola-Malpighi, 40138 - Bologna/IT
  • 9 Oncology Medical, Azienda Ospedaliera Universitaria S.Chiara, 56100 - Pisa/IT
  • 10 Medical Oncology Department, Mayo Clinic, 55905 - Rochester/US
  • 11 Oncology Medical, Tom Baker Center, 1131 - Calgary/CA
  • 12 Division Of Hematology/oncology, Vanderbilt Ingram Cancer Center, 37232 - Nashville/US
  • 13 Princess Margaret Cancer Centre, Princess Margaret Cancer Center, M5G 2M9 - Toronto/CA
  • 14 Ditep, Institut Gustave Roussy, 94805 - Villejuif/FR
  • 15 Medical Oncology Dept., Vall d'Hebron Institute of Oncology (VHIO)-Cellex Center, 8035 - Barcelona/ES
  • 16 Oncology Dept, Basilea Pharmaceutica Ltd., 4005 - Basel/CH
  • 17 Development Department, Basilea Pharmaceutica Ltd., 4005 - Basel/CH
  • 18 Gastrointestinal Medical Oncology, MD Anderson Cancer Center, 77030-4095 - Houston/US
  • 19 Oncology Department, Mayo Clinic Cancer Center, 85259 - Scottsdale/US
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Abstract 47P

Background

FGFR2 fusions/rearrangements (FGFR2fus) occur in ∼15% of patients (pts) with intrahepatic cholangiocarcinoma (iCCA), a disease with poor outcomes upon progression after 1L standard treatment. Derazantinib is a potent FGFR1-3 kinase inhibitor that has shown broad clinical activity in iCCA pts with FGFR2 fusions, mutations and amplifications. Here, we present efficacy and safety data for the completed FGFR2fus+ cohort from study FIDES-01.

Methods

Eligible pts with advanced iCCA, ≥1L of prior treatment and a confirmed FGFR2fus received derazantinib 300 mg QD. Primary endpoint was objective response rate (ORR) by independent central review per RECIST v1.1; secondary endpoints included duration of response (DOR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS) and safety.

Results

103 FGFR2fus+ pts were enrolled; 65% were female, 50% were ≥56 years, and 47% had ≥2 prior treatment lines. At data cutoff (April 25, 2021), 91% of pts had discontinued treatment. The study met its primary endpoint with a centrally confirmed ORR of 21.4% (95% CI 13.9, 30.5) including 22 PRs; DCR was 74.8%; median (m) DOR was 6.4 mo (95% CI 3.9, 9.2) with a probability of 68% of retaining a response for ≥6 mo; mPFS was 7.8 mo (95% CI 5.5, 8.2); mOS was 15.5 mo (95% CI 11.8, 21.9). Efficacy outcomes were consistent in 2L and 3+L treatment (ORR: 21.8% in 2L / 20.8% in 3+L; mPFS 6.0 / 8.2 mo in 2L / 3+L). Most common adverse drug reactions (ADRs) were hyperphosphatemia (37% ADRs; 70% laboratory values), asthenia/fatigue (31%), transaminase elevations (31%), nausea (30%), dry eye (26%), and dry mouth (21%); most common grade ≥3 ADRs were transaminase elevations (12%), fatigue/asthenia (5%), hyperphosphatemia (4%), and abdominal pain (3%). Drug-related retinal events (1%; grade 1), nail toxicities (6%, grade ≤2), stomatitis (2%, grade 1) and hand-foot syndrome (1%, grade 1) were rare.

Conclusions

Derazantinib showed clinically meaningful efficacy with durable objective responses, and a manageable safety profile with a particularly low incidence of drug-related hand-foot syndrome, stomatitis, retinal or nail toxicity in pts with iCCA harboring FGFR2fus.

Clinical trial identification

NCT03230318.

Editorial acknowledgement

Legal entity responsible for the study

Basilea Pharmaceutica International Ltd.

Funding

Basilea Pharmaceutic International Ltd.

Disclosure

W. L.Shaib: Financial Interests, Personal, Research Grant: Basilea; GSK; Lexicon; Eli Lilly; Astellas. K. Mody: Financial Interests, Personal, Other, Consulting fees: BTG Consulting; Financial Interests, Institutional, Other, Consulting fees: Exelixis; Genentech; Financial Interests, Personal, Other, Consulting fees: Incyte; Ipsen; QED; Financial Interests, Institutional, Other, Consulting fees: Taiho; AstraZeneca. N. Personeni: Financial Interests, Personal, Other, Consulting fees: Amgen, Merck Serono, Servier; Financial Interests, Institutional, Research Grant: Merck Serono; Servier; Basilea; Financial Interests, Personal, Other, Travel expense: Amgen, ArQule; Financial Interests, Personal, Other, Lecture fees: AbbVie; Gilead; Lilly; Sanofi. W.P. Harris: Financial Interests, Personal, Advisory Board: Genentech; Exelixis; Eisai; Zymeworks; Financial Interests, Personal, Other: Merck; Financial Interests, Institutional, Research Grant: BMS; Financial Interests, Institutional, Research Grant: Medimmune; Agios; Bayer; BTG; Koo Foundation; Basilea. G. Masi: Financial Interests, Personal, Invited Speaker: Sirtex; Bayer; Amgen; Roche; Merck-Serono; MSD. T.R. Halfdanarson: Financial Interests, Institutional, Officer, consulting/ advisory fees: Advanced Accelerator Applications; Financial Interests, Personal, Other, consulting/ advisory fees: Curium Pharma; ScioScientific; Terumo; Financial Interests, Institutional, Other, consulting/ advisory fees: Ipsen; Lexicon; Financial Interests, Institutional, Research Grant: Argios; Arqule; Basilea; Thermo Fisher; Scientific.V. Tam: Financial Interests, Personal and Institutional, Advisory Board, Speaker/ Research/Educational Grants: Eisai; Ipsen; Roche; Financial Interests, Personal, Advisory Board: Incyte; Financial Interests, Personal, Invited Speaker: AstraZeneca.L.W. Goff: Financial Interests, Personal, Advisory Board: Lilly; Eisai; Bayer/Onyx; Newlink Genetics; Competetive Drug Development International; QED Therapeutics; Genentech; Merck; AstraZeneca; Financial Interests, Institutional, Research Grant: Astellas Pharma; Pfizer; Onyx; Sun Pharma; Lilly; Bristol-Myers Squibb; Agios; ArQule; H3 Biomedicine; Incyte; Leap Therapeutics; ASLAN Pharmaceuticals; BeiGene; Basilea; Merck.J. Knox: Financial Interests, Personal, Invited Speaker, Honoraria: Novartis; Roche; Financial Interests, Personal, Other, Consulting, Research Funds, Expert Testimony: AstraZeneca/MedImmune; Financial Interests, Personal, Other, Research Funds: Ipsen; Financial Interests, Personal, Other, Research Funds, Consulting: Merck; Financial Interests, Personal, Other, Consulting fees: Lilly.A. Hollebecque: Financial Interests, Personal, Other, Consulting fees: Amgen, BMS, Eisai; Debiopharm; QED Therapeutics; Non-Financial Interests, Personal, Other: Lilly; Financial Interests, Personal, Other, Consulting fees and non-financial support: Incyte; Financial Interests, Personal, Other: AstraZeneca; Roche; Servier. T. Macarulla Mercade: Financial Interests, Personal, Other, Consulting fees: Ability Pharmaceutical; Financial Interests, Personal, Other, Consulting fees: SL; Financial Interests, Personal, Other, Consulting fees: Advance Medical HCMS; Financial Interests, Personal, Other, Consulting fees: Baxter; BioLineRXLtd; Celegene SLU; Eisai; Genzyme; Incyte; Ipsen Pharma Lab; Lab. Servier; Financial Interests, Personal and Institutional, Other, Consulting fees: Lilly; Financial Interests, Personal, Other, Consulting fees: Merck; Sharp and Dhome; QED Therapeutics Inc; Sanofi-Aventis; Financial Interests, Personal and Institutional, Other, Consulting fees: Roche; Financial Interests, Institutional, Other: Agios; Aslan; AstraZencena; Bayer; Celgene; Genentech; Hallozyme; Immunomedics; Merimarck; Millenim; Novartis; Pfizer; Pharmacyclics. F. Cantero: Financial Interests, Personal, Full or part-time Employment: Basilea Pharmaceutica International. M. Saulay: Financial Interests, Personal, Full or part-time Employment: Basilea Pharmaceutica International. S. Braun: Financial Interests, Personal, Full or part-time Employment, Shareholder: Basilea Pharmaceutica International. M. Javle: Financial Interests, Personal, Research Grant: Merck, EMD Serono, Basilea, QED, Incyte, Taiho, Agios; Meclun; Transthera, Pieris; Oncosil; BMS, ELi Lilly Novartis. M. Borad: Financial Interests, Institutional, Other, Clinical Trial Support: Basilea. All other authors have declared no conflicts of interest.

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