The Absolute Effect / Oncology Evidence / Evidence Index

Non-Small Cell Lung Cancer · Medical · Advanced / Metastatic · First-line metastatic squamous NSCLC

KEYNOTE-407

In previously untreated metastatic squamous NSCLC, does pembrolizumab plus platinum-taxane chemotherapy improve overall and progression-free survival over chemotherapy alone?

Registry: NCT02775435 · Evidence reviewed 9 November 2026 · Aliases and follow-up publications consolidated.

Phase III, double-blind randomized; n=559.Primary-source evidence summary

Study design, population and eligibility

Design and sample

Phase III, double-blind randomized; n=559.

Population

Untreated metastatic squamous NSCLC, all PD-L1 strata.

Treatment and comparator

Intervention: Pembrolizumab + carboplatin + paclitaxel/nab-paclitaxel, then pembrolizumab.

Comparator: Placebo + same chemotherapy.

Endpoints

OS and PFS by blinded independent review.

Key efficacy and clinical outcomes

At ~5 y: OS HR 0.71; PFS HR 0.62; 5-y OS 18.4% vs 9.7%; PFS 10.8% vs 3.5%; ORR 62.2% vs 38.8%.

Source-reported outcome visualization

Values are reproduced from the cited report; bars are scaled within this figure. First-line metastatic squamous NSCLC

5-y OS pembrolizumab+chemo

18.4%

5-y OS chemo

9.7%

Median survival and hazard ratios are not fixed-time event risks; NNT is not inferred from them.

Toxicity and treatment burden

Grade 3–5 toxicity is common with chemo-immunotherapy; immune-mediated events add to platinum-taxane burden.

Absolute effect and NNT/NNH

Applies to squamous histology. Landmark rates are not NNTs.

NNT/NNH is not calculated unless a directly reported, comparable fixed-time risk difference supports it. Median survival and hazard ratios alone do not provide an NNT.

Critical interpretation and limitations

Applies to squamous histology. Landmark rates are not NNTs.

This page is an evidence summary, not a substitute for multidisciplinary assessment or patient-specific decision-making.

Current-practice context

Review date: 9 November 2026. Primary publication and selected follow-up sources were reviewed. Full disease-specific guideline, regulatory-label and sequencing audit remains pending; verify current local recommendations and biomarker eligibility before clinical application.

Primary publication and authoritative source

https://pubmed.ncbi.nlm.nih.gov/36735893/

ClinicalTrials.gov NCT02775435