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Poster Discussion session -Gastrointestinal, non-colorectal

3652 - Updated results from a phase II study of infigratinib (BGJ398), a selective pan-FGFR kinase inhibitor, in patients with previously treated advanced cholangiocarcinoma containing FGFR2 fusions


19 Oct 2018


Poster Discussion session -Gastrointestinal, non-colorectal


Cytotoxic Therapy;  Clinical Research;  Targeted Therapy;  Translational Research

Tumour Site

Hepatobiliary Cancers


Milind Javle


M. Javle1, R..K. Kelley2, S. Roychowdhury3, K.H. Weiss4, G.K. Abou-Alfa5, T. Macarulla6, S. Sadeghi7, D. Waldschmidt8, A.X. Zhu9, L. Goyal10, M. Borad11, W.P. Yong12, I. Borbath13, A. El-Khoueiry14, P. Philip15, S. Moran16, Y. Ye17, M. Ising18, N. Lewis19, T. Bekaii-Saab20

Author affiliations

  • 1 Gastrointestinal Medical Oncology, MD Anderson Cancer Center, 77030 - Houston/US
  • 2 Medicine (hematology/oncology), University of California San Francisco, San Francisco/US
  • 3 Internal Medicine, Ohio State Comprehensive Cancer Center/James Cancer Hospital, Columbus/US
  • 4 Internal Medicine Iv, University Hospital Heidelberg, Heidelberg/DE
  • 5 Medicine, Memorial Sloan Kettering Cancer Center, New York City/US
  • 6 Medical Oncology, Hospital Vall d’Hebron, Barcelona/ES
  • 7 Medicine, University of California at Los Angeles, 90404 - Santa Monica/US
  • 8 Gastroenterology And Hepatology, Klinikum der Universität zu Köln, Köln/DE
  • 9 Hematology/oncology, Medicine, Massachusetts General Hospital, 02114 - Boston/US
  • 10 Hematology/oncology, Medicine, Massachusetts General Hospital, Boston/US
  • 11 Internal Medicine, Mayo Clinic Arizona, Scottsdale/US
  • 12 Hematology-oncology, National University Cancer Institute Singapore, S119228 - Singapore/SG
  • 13 Hepatogastroenterology And Digestive Oncology, Cliniques universitaires St Luc Bruxelles, Bruxelles/BE
  • 14 Medicine, USC/Kenneth Norris Comprehensive Cancer Center, Los Angeles/US
  • 15 Oncology, Karmanos Cancer Institute, Detroit/US
  • 16 Clinical Development, QED Therapeutics, San Francisco/US
  • 17 Biostatistics And Data Management, QED Therapeutics, San Francisco/US
  • 18 Translation Clinical Oncology, Novartis, Florham Park/US
  • 19 Translational Clinical Oncology, Novartis Pharmaceutical Corporation, East Hanover/US
  • 20 Internal Medicine, Mayo Clinic, Scottsdale/US


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Abstract 3652


Fibroblast growth factor receptor 2 (FGFR2) fusions occur in 13–17% of intrahepatic cholangiocarcinomas (IHC). A multicenter, open-label, phase II study (NCT02150967) evaluated the antitumor activity of infigratinib, an ATP-competitive FGFR1–3-selective oral tyrosine kinase inhibitor, in patients (pts) with previously-treated advanced IHC containing FGFR2 fusions.


Pts received infigratinib 125 mg orally daily for 21 days of 28-day cycles until unacceptable toxicity, disease progression, investigator discretion, or withdrawal of consent. Primary endpoint: investigator-assessed confirmed overall response rate (cORR, RECIST 1.1). Secondary endpoints: progression-free survival (PFS), disease control rate (DCR), best overall response, overall survival (OS), safety, pharmacokinetics.


71 pts (62% women; median age 53 years; median 2 prior lines of therapy) with FGFR2 fusions/translocations were included. At the prespecified data cutoff (8-Aug-2018), median duration of treatment was 5.5 months, median duration of follow-up was 8.4 months, and 62 pts had discontinued treatment. The ORR (confirmed and unconfirmed) was 31.0% (95% CI 20.5–43.1%) and the cORR (in pts with potential for confirmation) was 26.9% (95% CI 16.8–39.1%). Other efficacy findings: cORR in pts receiving ≤1 prior lines of treatment was 39.3% (n=28), and ≥2 17.9% (n=39); DCR 83.6% (95% CI 72.5–91.5%); median duration of response 5.4 (95% CI 3.7–7.4) months; median PFS 6.8 (95% CI 5.3–7.6) months; median OS 12.5 (95% CI 9.9–16.6) months. Most common any-grade treatment-emergent adverse events (TEAEs): hyperphosphatemia (73.2%), fatigue (49.3%), stomatitis (45.1%), alopecia (38.0%), constipation (35.2%). Grade 3/4 TEAEs occurred in 47 pts (66.2%), including hypophosphatemia (14.1%), hyperphosphatemia (12.7%), and hyponatremia (11.3%).


Infigratinib-associated toxicity is manageable, and our efficacy findings suggest clinically meaningful activity after chemotherapy in pts with IHC containing FGFR2 fusions. The efficacy of infigratinib in this study supports FGFR2 as a therapeutic target in FGFR2-fusion IHC.

Clinical trial identification


Editorial Acknowledgement

Editorial assistance was provided by Lee Miller from Miller Medical Communications Ltd

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