The Absolute Effect / Oncology Evidence / Evidence Index

Non-Small Cell Lung Cancer · Medical · Advanced / Metastatic · First-line metastatic NSCLC · PD-L1 TPS ≥50%

KEYNOTE-024

In untreated metastatic NSCLC with PD-L1 TPS ≥50% and no sensitizing EGFR/ALK alteration, does pembrolizumab monotherapy improve survival over platinum chemotherapy?

Registry: NCT02142738 · Evidence reviewed 9 November 2026 · Aliases and follow-up publications consolidated.

Phase III open-label randomized; n=305.Primary-source evidence summary

Study design, population and eligibility

Design and sample

Phase III open-label randomized; n=305.

Population

Untreated advanced NSCLC, PD-L1 TPS ≥50%, no sensitizing EGFR/ALK alteration.

Treatment and comparator

Intervention: Pembrolizumab up to 35 cycles.

Comparator: Platinum chemotherapy; crossover permitted.

Endpoints

PFS primary; OS secondary.

Key efficacy and clinical outcomes

At 5 y: median OS 26.3 vs 13.4 mo (HR 0.62); 5-y OS 31.9% vs 16.3%, despite 66% effective crossover.

Source-reported outcome visualization

Values are reproduced from the cited report; bars are scaled within this figure. First-line metastatic NSCLC · PD-L1 TPS ≥50%

5-y OS pembrolizumab

31.9%

5-y OS chemotherapy

16.3%

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

Toxicity and treatment burden

Grade 3–5 treatment-related AEs 31.2% vs 53.3% in long-term report; immune toxicity remains relevant.

Absolute effect and NNT/NNH

Do not extrapolate to TPS 1–49%; crossover affects OS interpretation.

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

Do not extrapolate to TPS 1–49%; crossover affects OS interpretation.

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/33872070/

ClinicalTrials.gov NCT02142738