ClarIDHy
The first randomised trial of a targeted drug in bile duct cancer; it slowed the disease without shrinking it.
PFS 2.7 vs 1.4 months (HR 0.37); OS 10.3 vs 7.5 months after adjusting for crossover (HR 0.49); ORR 2%.
Setting
Previously treated IDH1-mutant cholangiocarcinoma: ivosidenib vs placebo
Phase
Phase 3
Sponsor
Agios (now Servier)
Registry
Headline result
PFS HR 0.37; crossover-adjusted OS HR 0.49.
Reported
2020
Enrolled
187
In plain words
What these results mean for people, not percentages
Progression-free survivalprimarysurrogate endpoint
- Median 2.7 vs 1.4 months with Ivosidenib compared with Placebo; about 1.3 months longer for half the group.
- A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
- Put another way, the treated group had about 63 percent lower chance of the event at any given time (hazard ratio 0.37, likely range 0.25 to 0.54).
- 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 survival (crossover-adjusted)survival endpoint
- Median 10.3 vs 7.5 months with Ivosidenib compared with Placebo; about 2.8 months longer for half the group.
- A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
- Put another way, the treated group had about 51 percent lower chance of the event at any given time (hazard ratio 0.49).
- 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 IDH1-mutant cholangiocarcinoma: ivosidenib vs placebo. People in a different situation may not see the same effect.
- The trial selected people by a biomarker (IDH1); 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.
187 participants enrolled.
Progression-free survivalprimary
HR 0.37 (0.25–0.54) · p <0.0001
Ivosidenib
2.7 mo
Placebo
1.4 mo
Overall survival (crossover-adjusted)
HR 0.49
Ivosidenib
10.3 mo
Placebo
7.5 mo
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Progression-free survivalprimary | Ivosidenib | 126 | 2.7 months | 0.37 (0.25–0.54) | <0.0001 | — |
| Placebo | 61 | 1.4 months | ||||
| Overall survival (crossover-adjusted) | Ivosidenib | — | 10.3 months | 0.49 | — | — |
| Placebo | — | 7.5 months |
Pages like this
not linked directly; found by shared links- TrialAGILE
Shares Ivosidenib, IDH1 / IDH2.
- TermIntrahepatic, perihilar, distal and gallbladder cancer
Shares IDH1 / IDH2, Biliary tract cancer (cholangiocarcinoma).
- InstitutionNational Cancer Centre Singapore
Shares IDH1 / IDH2, Biliary tract cancer (cholangiocarcinoma).
- CompanyServier
Shares Ivosidenib, Biliary tract cancer (cholangiocarcinoma).
- TermDifferentiation syndrome
Shares Ivosidenib, IDH1 / IDH2.
- PathwayGlutamine addiction
Shares Ivosidenib, IDH1 / IDH2.
- PathwayCancer metabolism
Shares Ivosidenib, IDH1 / IDH2.