KEYNOTE-966
A second immunotherapy trial confirmed the modest survival benefit of adding PD-1 blockade to chemotherapy in bile duct cancer.
OS 12.7 vs 10.9 months (HR 0.83); gemcitabine continued beyond 8 cycles in both arms. Approved October 2023.
- Median 12.7 vs 10.9 months with Pembrolizumab + GemCis compared with Placebo + GemCis; about 1.8 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 17 percent lower chance of the event at any given time (hazard ratio 0.83, likely range 0.72 to 0.95).
- 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 + pembrolizumab 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.
1,069 participants enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Overall survivalprimary | Pembrolizumab + GemCis | 533 | 12.7 months | 0.83 (0.72–0.95) | 0.0034 | — |
| Placebo + GemCis | 536 | 10.9 months |
Pages like this
not linked directly; found by shared links- TrialTOPAZ-1
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).
- PersonDo-Youn Oh
Shares Gemcitabine + cisplatin, Biliary tract cancer (cholangiocarcinoma).
- CancerCancer of unknown primary (CUP)
Shares Gemcitabine + cisplatin, Pembrolizumab.
- CancerNasopharyngeal carcinoma
Shares Gemcitabine + cisplatin, Pembrolizumab.