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  5. Biomedical And Clinical Sciences
  7. Oncology And Carcinogenesis
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  11. A Phase Ii, Multicenter, Single-arm Study Of Pemigatinib In Patients With Metastatic Or Unresectable Colorectal Cancer Harboring Fgfr Alterations

A phase II, multicenter, single-arm study of pemigatinib in patients with metastatic or unresectable colorectal cancer harboring FGFR alterations

Margaret C Wheless1, Tyler J Zemla2, Joleen M Hubbard3

  • 1Department of Internal Medicine, Division of Hematology/Oncology, Vanderbilt University Medical Center, Nashville, TN, United States.

The Oncologist
|June 14, 2025

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View abstract on PubMed

Summary
This summary is machine-generated.

Pemigatinib did not show efficacy in treating advanced colorectal cancer with FGF/FGFR alterations. The trial was stopped early due to futility, with no objective responses observed in patients.

Area of Science:

  • Oncology
  • Medical Genetics
  • Clinical Pharmacology

Background:

  • Fibroblast Growth Factor Receptor (FGFR) alterations are recognized drivers in various cancers.
  • Colorectal cancer (CRC) with FGF/FGFR alterations represents a potential target for specific therapies.

Purpose of the Study:

  • To evaluate the efficacy of pemigatinib, an oral FGFR1-3 inhibitor, in patients with metastatic or unresectable colorectal cancer.
  • To assess the impact of FGF/FGFR alterations on treatment response in this patient population.

Main Methods:

  • A single-arm, phase II clinical trial (ACCRU-GI-1701) enrolled patients with previously treated, FGF/FGFR-altered metastatic CRC.
  • Patients received daily oral pemigatinib in 21-day cycles.
  • Primary endpoint was objective response rate; secondary endpoints included clinical benefit, survival, quality of life, and adverse events.
Keywords:
FGFFGFRcolorectal cancerpemigatinib

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Main Results:

  • The interim analysis of 14 patients showed an objective response rate and clinical benefit rate of 0%.
  • The trial was terminated early due to futility.
  • Grade 3 or higher adverse events occurred in 42.9% of patients, most commonly anemia and fatigue.

Conclusions:

  • Pemigatinib monotherapy demonstrated no objective responses in chemorefractory metastatic colorectal cancer patients with FGF/FGFR alterations.
  • The drug was generally well-tolerated, with no new safety concerns identified.
  • Most patients (93%) had FGF/FGFR mutations and amplifications; one had an FGFR3-WHSC1 fusion.