TOPAZ-1
TOPAZ-1 was the first immunotherapy success in bile duct cancer, with a small median gain but a growing tail of long survivors.
OS 12.9 vs 11.3 months (HR 0.76 updated); 24-month OS 23.6% vs 11.5%; 3-year OS update (J Hepatol 2025) confirmed the durable tail. Approved September 2022.
- Median 12.9 vs 11.3 months with Durvalumab + GemCis compared with Placebo + GemCis; about 1.6 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 24 percent lower chance of the event at any given time (hazard ratio 0.76, likely range 0.64 to 0.91).
- 23.6 vs 11.5 out of 100 alive with Durvalumab + GemCis compared with Placebo + GemCis; 12.1 more per 100.
- Roughly one extra person helped for every 8 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
- Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.
- These results apply to the people the trial enrolled: First-line advanced biliary tract cancer: gemcitabine-cisplatin + durvalumab vs + placebo. People in a different situation may not see the same effect.
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.
685 participants enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Overall survival (updated)primary | Durvalumab + GemCis | 341 | 12.9 months | 0.76 (0.64–0.91) | — | — |
| Placebo + GemCis | 344 | 11.3 months | ||||
| 24-month overall survival | Durvalumab + GemCis | — | 23.6% | — | — | — |
| Placebo + GemCis | — | 11.5% |
Pages like this
not linked directly; found by shared links- TrialKEYNOTE-966
Shares Gemcitabine-cisplatin + PD-(L)1 blockade in biliary cancer, Gemcitabine + cisplatin, Biliary tract cancer (cholangiocarcinoma).
- TrialABC-02
Shares Gemcitabine + cisplatin, Biliary tract cancer (cholangiocarcinoma).
- TrialHERIZON-BTC-302
Shares Gemcitabine + cisplatin, Biliary tract cancer (cholangiocarcinoma).
- InstitutionIRCCS Humanitas Research Hospital
Shares Durvalumab, Biliary tract cancer (cholangiocarcinoma).