# KEYNOTE-119

Source: https://onco.cc/trials/keynote-119/  
OnCo record `keynote-119` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

KEYNOTE-119 tested pembrolizumab on its own against chemotherapy as second- or third-line treatment for metastatic triple-negative breast cancer. It did not lengthen life, even in tumours with high PD-L1, which is why immunotherapy in this disease is given with chemotherapy or an antibody-drug conjugate and only in the first line.

## Summary

KEYNOTE-119 (NCT02555657) randomised 622 patients with centrally confirmed metastatic triple-negative breast cancer, one or two prior systemic treatments and prior anthracycline or taxane, 1 to 1 to pembrolizumab 200 mg every 3 weeks for up to 35 cycles or single-agent chemotherapy of the investigator's choice (capecitabine, eribulin, gemcitabine or vinorelbine). The primary endpoint was overall survival tested hierarchically in CPS 10 or more, CPS 1 or more and all patients. At a median follow-up of 31.4 months median overall survival in CPS 10 or more was 12.7 versus 11.6 months (hazard ratio 0.78, 95 percent confidence interval 0.57 to 1.06, p 0.057), in CPS 1 or more 10.7 versus 10.2 months (0.86, 0.69 to 1.06, p 0.073) and overall 9.9 versus 10.8 months (0.97, 0.82 to 1.15). Grade 3 to 4 treatment-related adverse events were far less common with pembrolizumab (for example neutropenia below 1 versus 10 percent). The trend with rising PD-L1 expression fed the CPS 10 threshold used in KEYNOTE-355, but the trial itself was negative, pembrolizumab has no monotherapy indication in breast cancer, and NICE discontinued its appraisal of pembrolizumab for previously treated metastatic triple-negative disease (GID-TA10295).

## Fields

- Kind: Trial
- Status: negative
- Last checked: 2026-09-24
- Registry id: NCT02555657
- Phase: 3
- Setting: Metastatic triple-negative breast cancer after one or two prior systemic treatments: pembrolizumab monotherapy versus investigator's choice of capecitabine, eribulin, gemcitabine or vinorelbine, 150 centres in 31 countries
- Sponsor: Merck Sharp & Dohme
- Enrolled: 622
- Result: OS in CPS 10 or more 12.7 vs 11.6 months (HR 0.78, p 0.057); CPS 1 or more 10.7 vs 10.2 (HR 0.86); all patients 9.9 vs 10.8 (HR 0.97). Negative.
- Outcomes: Overall survival, PD-L1 CPS 10 or more: Pembrolizumab 12.7 months vs Chemotherapy 11.6 months, HR 0.78; Overall survival, PD-L1 CPS 1 or more: Pembrolizumab 10.7 months vs Chemotherapy 10.2 months, HR 0.86; Overall survival, all patients: Pembrolizumab 9.9 months vs Chemotherapy 10.8 months, HR 0.97
- Replication: The PD-L1 gradient was confirmed by KEYNOTE-355, where pembrolizumab with chemotherapy improved survival only at CPS 10 or more.

## Sources

- ClinicalTrials.gov NCT02555657: https://clinicaltrials.gov/study/NCT02555657
- Winer et al., Lancet Oncology 2021: pembrolizumab versus investigator-choice chemotherapy for metastatic TNBC (KEYNOTE-119): https://doi.org/10.1016/S1470-2045(20)30754-3

## Connected records

- cancers: [Metastatic triple-negative breast cancer](https://onco.cc/cancers/tnbc-metastatic/), [Triple-negative breast cancer (TNBC)](https://onco.cc/cancers/tnbc/)
- technologies: [Cytotoxic chemotherapy](https://onco.cc/technologies/cytotoxic-chemotherapy/), [Immune checkpoint inhibitors](https://onco.cc/technologies/checkpoint-inhibitor/)
- drugs: [Capecitabine](https://onco.cc/drugs/capecitabine/), [Eribulin](https://onco.cc/drugs/eribulin/), [Gemcitabine](https://onco.cc/drugs/gemcitabine/), [Pembrolizumab](https://onco.cc/drugs/pembrolizumab/), [Vinorelbine](https://onco.cc/drugs/vinorelbine/)
- companies: [Merck & Co. (MSD)](https://onco.cc/companies/merck/)
- terms: [Combined positive score (CPS)](https://onco.cc/terms/cps/)
- trials: [ASCENT](https://onco.cc/trials/ascent/), [KEYNOTE-355](https://onco.cc/trials/keynote-355/)

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