# KEYNOTE-966: pembrolizumab plus gemcitabine and cisplatin for advanced biliary tract cancer

Source: https://onco.cc/key-papers/paper-keynote-966-lancet-2023/  
OnCo record `paper-keynote-966-lancet-2023` (Key paper). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Adding pembrolizumab to gemcitabine-cisplatin, with gemcitabine continued as maintenance, lengthened survival in advanced biliary tract cancer by about two months, confirming the role of chemo-immunotherapy shown by TOPAZ-1.

## Summary

Phase 3 placebo-controlled trial of 1,069 patients with untreated metastatic or unresectable biliary tract cancer randomised to pembrolizumab or placebo with gemcitabine-cisplatin, with gemcitabine continued beyond eight cycles.

Median overall survival was 12.7 versus 10.9 months (hazard ratio 0.83), with a consistent effect across subgroups and no new safety signals.

## Fields

- Kind: Key paper
- Last checked: 2026-09-17
- Journal: The Lancet
- Year: 2023
- DOI: 10.1016/S0140-6736(23)00727-4
- Authors: Kelley RK, Ueno M, Yoo C, et al.
- Findings: Median overall survival 12.7 vs 10.9 months; hazard ratio 0.83.; Median progression-free survival 6.5 vs 5.6 months.
- What it means: Pembrolizumab with gemcitabine-cisplatin is an approved first-line option for advanced biliary tract cancer alongside durvalumab-based therapy.
- Caveats: Modest absolute gain; no biomarker enrichment.

## Sources

- Lancet 2023: https://doi.org/10.1016/S0140-6736(23)00727-4
- PubMed: https://pubmed.ncbi.nlm.nih.gov/37075781/

## Connected records

- cancers: [Intrahepatic cholangiocarcinoma](https://onco.cc/cancers/intrahepatic-cholangiocarcinoma/)
- drugs: [Cisplatin](https://onco.cc/drugs/cisplatin/), [Gemcitabine](https://onco.cc/drugs/gemcitabine/), [Pembrolizumab](https://onco.cc/drugs/pembrolizumab/)
- trials: [KEYNOTE-966](https://onco.cc/trials/keynote-966/)
- journals: [The Lancet](https://onco.cc/journals/lancet/)

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