FOENIX-CCA2
Futibatinib produced responses in over 40% of patients whose bile duct cancer carried an FGFR2 fusion.
ORR 42%, median PFS 9.0 months, median OS 21.7 months (NEJM 2023).
Setting
Previously treated FGFR2-rearranged intrahepatic cholangiocarcinoma: futibatinib single arm
Phase
Phase 2
Sponsor
Taiho
Registry
Headline result
ORR 42%; PFS 9.0 months; OS 21.7 months.
Reported
2022
Enrolled
103
In plain words
What these results mean for people, not percentages
Objective response rateprimaryresponse endpoint
- 42 out of 100 people had their tumour shrink with Futibatinib.
- There was no comparison group, so this number cannot tell you how much of the effect is due to the treatment.
- A response rate counts how many people had their tumours shrink by a set amount; shrinking is encouraging but does not by itself show that people live longer or feel better.
Progression-free survivalsurrogate endpoint
- Median 9 months with Futibatinib.
- A median is a midpoint: half the people did better than this and half did worse.
- This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.
Overall survivalsurvival endpoint
- Median 21.7 months with Futibatinib.
- A median is a midpoint: half the people did better than this and half did worse.
- Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.
Be careful
- These results apply to the people the trial enrolled: Previously treated FGFR2-rearranged intrahepatic cholangiocarcinoma: futibatinib single arm. People in a different situation may not see the same effect.
- The trial selected people by a biomarker (FGFR2); the result should not be assumed for people whose cancer does not have it.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
103 participants enrolled.
Objective response rateprimary
Futibatinib42 of 100
n = 103
Progression-free survival
Futibatinib
9 mo
Overall survival
Futibatinib
21.7 mo
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Objective response rateprimary | Futibatinib | 103 | 42% | — | — | — |
| Progression-free survival | Futibatinib | — | 9 months | — | — | — |
| Overall survival | Futibatinib | — | 21.7 months | — | — | — |
Pages like this
not linked directly; found by shared links- TermFGFR2 fusions and rearrangements
Shares Futibatinib, FGFR2, Biliary tract cancer (cholangiocarcinoma).
- TrialFIGHT-202
- TrialFIRST-308
- CompanyTaiho Pharmaceutical (Otsuka)
Shares Futibatinib, Biliary tract cancer (cholangiocarcinoma).
- TermIntrahepatic, perihilar, distal and gallbladder cancer
- IdeactDNA-guided switching among FGFR inhibitors
Shares Futibatinib, FGFR2, Biliary tract cancer (cholangiocarcinoma).
- ProductPemigatinib
- PersonTanios Bekaii-Saab