# FOENIX-CCA2

Source: https://onco.cc/trials/foenix-cca2/  
OnCo record `foenix-cca2` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Futibatinib produced responses in over 40% of patients whose bile duct cancer carried an FGFR2 fusion.

## Summary

FOENIX-CCA2, trial NCT02052778 sponsored by Taiho and reported in 2022 with publication in the New England Journal of Medicine in 2023, showed that futibatinib produced responses in more than forty percent of patients whose previously treated intrahepatic cholangiocarcinoma carried an FGFR2 rearrangement. It was a single-arm phase 2 of 103 patients with an objective response rate of 42 percent and durable disease control, supporting approval. OnCo links it to biliary tract cancer, FGFR2 as a target, futibatinib and Lipika Goyal. As with pemigatinib, the absence of a randomised comparison leaves open whether an irreversible FGFR inhibitor improves survival over chemotherapy and how it should be sequenced with other FGFR drugs.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-07
- Registry id: NCT02052778
- Phase: 1/2
- Setting: Previously treated FGFR2-rearranged intrahepatic cholangiocarcinoma: futibatinib single arm
- Sponsor: Taiho
- Enrolled: 103
- Result: ORR 42%; PFS 9.0 months; OS 21.7 months.
- Outcomes: Objective response rate: Futibatinib 42%; Progression-free survival: Futibatinib 9 months; Overall survival: Futibatinib 21.7 months

## Sources

- ClinicalTrials.gov NCT02052778: https://clinicaltrials.gov/study/NCT02052778
- NEJM 2023: https://www.nejm.org/doi/full/10.1056/NEJMoa2206834

## Connected records

- cancers: [Biliary tract cancer (cholangiocarcinoma)](https://onco.cc/cancers/cholangiocarcinoma/), [Intrahepatic cholangiocarcinoma](https://onco.cc/cancers/intrahepatic-cholangiocarcinoma/)
- technologies: [Small-molecule kinase inhibitors](https://onco.cc/technologies/kinase-inhibitors/)
- targets: [FGFR2](https://onco.cc/targets/fgfr2/)
- drugs: [Futibatinib](https://onco.cc/drugs/futibatinib/)
- companies: [Taiho Pharmaceutical (Otsuka)](https://onco.cc/companies/taiho/)
- people: [Lipika Goyal](https://onco.cc/people/lipika-goyal/)

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JSON: https://onco.cc/api/v1/entities/foenix-cca2.json