# KEYNOTE-010 (Herbst 2016): pembrolizumab versus docetaxel in previously treated PD-L1-positive lung cancer

Source: https://onco.cc/key-papers/paper-keynote-010-lancet-2016/  
OnCo record `paper-keynote-010-lancet-2016` (Key paper). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

After chemotherapy had failed, pembrolizumab prolonged life compared with docetaxel in lung cancers expressing any PD-L1, with the largest gain in tumours where at least half the cells were positive, and caused fewer severe side effects.

## Summary

KEYNOTE-010 randomised 1,034 patients with previously treated advanced non-small-cell lung cancer and a PD-L1 tumour proportion score of at least 1% to pembrolizumab at 2 mg/kg or 10 mg/kg or to docetaxel. Both pembrolizumab doses improved overall survival in the whole population and by a larger margin in the group with a score of 50% or more, with fewer grade 3 to 5 treatment-related adverse events than docetaxel. It secured pembrolizumab's regular approval in previously treated lung cancer and established PD-L1 of 1% as the entry threshold for that use.

## Fields

- Kind: Key paper
- Last checked: 2026-09-08
- Journal: The Lancet
- Year: 2016
- DOI: 10.1016/S0140-6736(15)01281-7
- Authors: Herbst RS, Baas P, Kim DW, et al.
- Findings: 1,034 patients with previously treated NSCLC and PD-L1 tumour proportion score of at least 1%; pembrolizumab 2 mg/kg, 10 mg/kg or docetaxel.; Median overall survival 10.4 and 12.7 months with pembrolizumab vs 8.5 months with docetaxel; hazard ratios 0.71 and 0.61.; In tumours with a score of 50% or more: median overall survival 14.9 and 17.3 vs 8.2 months; hazard ratios 0.54 and 0.50.; Grade 3 to 5 treatment-related adverse events 13% and 16% vs 35%.
- What it means: Alongside the CheckMate trials this study replaced docetaxel with PD-1 blockade as second-line treatment for most lung cancers, and its PD-L1 threshold of 1% became the basis of pembrolizumab's label in previously treated disease.
- Caveats: Open-label design.; Patients with PD-L1-negative tumours were excluded, so the trial says nothing about them.; Second-line setting; first-line immunotherapy has since reduced its relevance.

## Sources

- Full text (DOI): https://doi.org/10.1016/S0140-6736(15)01281-7
- ClinicalTrials.gov NCT01905657: https://clinicaltrials.gov/study/NCT01905657

## Connected records

- key papers: [CheckMate 057: nivolumab beats docetaxel after chemotherapy in non-squamous lung cancer](https://onco.cc/key-papers/paper-checkmate-057-nejm-2015/), [KEYNOTE-001 (Garon 2015): pembrolizumab in non-small-cell lung cancer and the 50% PD-L1 cut-off](https://onco.cc/key-papers/paper-keynote-001-pembrolizumab-nsclc-nejm-2015/)
- biomarkers: [PD-L1 TPS (tumour proportion score)](https://onco.cc/biomarkers/pd-l1-tps/)
- cancers: [Non-small-cell lung cancer](https://onco.cc/cancers/nsclc/)
- technologies: [Histopathology & immunohistochemistry](https://onco.cc/technologies/histopathology-ihc/), [Immune checkpoint inhibitors](https://onco.cc/technologies/checkpoint-inhibitor/)
- targets: [PD-1](https://onco.cc/targets/pd1/), [PD-L1](https://onco.cc/targets/pdl1/)
- drugs: [Docetaxel](https://onco.cc/drugs/docetaxel/), [Pembrolizumab](https://onco.cc/drugs/pembrolizumab/)
- companies: [Merck & Co. (MSD)](https://onco.cc/companies/merck/)
- pathways: [PD-1 / PD-L1 immune checkpoint & T-cell activation](https://onco.cc/pathways/pd1-checkpoint/)
- terms: [Immunohistochemistry (IHC)](https://onco.cc/terms/ihc/), [Overall survival (OS)](https://onco.cc/terms/os/), [Tumour proportion score (TPS)](https://onco.cc/terms/tps/)
- people: [Roy S. Herbst](https://onco.cc/people/roy-herbst/)
- ideas: [Extended-interval immunotherapy: give checkpoint inhibitors every 8-12 weeks once stable](https://onco.cc/ideas/idea-tr1-extended-interval-checkpoint-dosing/), [Randomised trials of stopping immunotherapy after one year versus continuing](https://onco.cc/ideas/idea-tr1-immunotherapy-stop-trials/)

---
JSON: https://onco.cc/api/v1/entities/paper-keynote-010-lancet-2016.json