FIGHT-202
FIGHT-202 is the single-arm study that produced the first targeted approval in bile duct cancer.
ORR 37% (35.5%), median PFS 7.0 months, median OS 17.5 months in FGFR2-fusion patients; no responses in other FGF/FGFR alterations.
Setting
Previously treated cholangiocarcinoma with FGFR2 fusions (cohort A): pemigatinib single arm
Phase
Phase 2
Sponsor
Incyte
Registry
Headline result
ORR 37%; PFS 7.0 months; OS 17.5 months.
Reported
2020
Enrolled
147
In plain words
What these results mean for people, not percentages
Objective response rateprimaryresponse endpoint
- 35.5 out of 100 people had their tumour shrink with Pemigatinib (FGFR2 fusion).
- 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 7 months with Pemigatinib.
- 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.
Be careful
- These results apply to the people the trial enrolled: Previously treated cholangiocarcinoma with FGFR2 fusions (cohort A): pemigatinib 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.
147 participants enrolled.
Objective response rateprimary
Pemigatinib (FGFR2 fusion)35.5 of 100
n = 107
Progression-free survival
Pemigatinib
7 mo
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Objective response rateprimary | Pemigatinib (FGFR2 fusion) | 107 | 35.5% | — | — | — |
| Progression-free survival | Pemigatinib | — | 7 months | — | — | — |