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Related Experiment Video

Updated: Dec 10, 2025

Author Spotlight: Advancements in Molecular Biomarker Testing for Non-Squamous Non-Small Cell Lung Cancer
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Patient-Centered Approach to Benefit-Risk Characterization Using Number Needed to Benefit and Number Needed to Harm:

Gokaraju K Raju1,2, Sean Khozin3, Karthik Gurumurthi1

  • 1Light Pharma, Cambridge, MA.

JCO Clinical Cancer Informatics
|August 28, 2020
PubMed
Summary

Number Needed to Benefit (NNB) and Number Needed to Harm (NNH) metrics offer patient-centric insights into non-small cell lung cancer (NSCLC) therapies. Analysis of 30 trials shows NNB improved over time, especially for targeted therapies in enriched populations.

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Area of Science:

  • Oncology
  • Clinical Trials
  • Biostatistics

Background:

  • Traditional metrics like hazard ratio may lack patient-centricity in clinical trial interpretation.
  • Number Needed to Benefit (NNB) and Number Needed to Harm (NNH) offer intuitive, patient-focused measures.
  • These metrics can complement existing measures like median time to event.

Purpose of the Study:

  • To summarize the benefit and risk of non-small cell lung cancer (NSCLC) therapies using NNB and NNH metrics.
  • To analyze trends in NNB over time and across patient subpopulations.
  • To evaluate the evolution of NNB for advanced NSCLC treatments from 2003 to 2017.

Main Methods:

  • Analysis of 30 clinical trials supporting US Food and Drug Administration (FDA) approval decisions for advanced NSCLC (2003-2017).
  • Characterization of efficacy and safety data using NNB and NNH metrics.
  • Assessment of NNB trends by treatment type (e.g., programmed death 1 inhibitors) and across subpopulations (e.g., EGFR mutation status, PD-L1 expression).

Main Results:

  • Average NNB was 4 for approved targeted therapies in molecularly enriched populations, 11 for non-enriched populations, and 23 for unapproved/withdrawn therapies.
  • NNB varied significantly across subpopulations based on EGFR mutations, PD-L1 expression, and ECOG performance status.
  • The NNB frontier decreased from 7.7 in 2003 to 2.5 in 2017 for best-case subpopulations and available drugs.

Conclusions:

  • NNB and NNH provide valuable, patient-centric insights into NSCLC therapy benefits and risks.
  • Therapeutic advancements in NSCLC have led to improved NNB over time, particularly in targeted therapies for specific molecular profiles.
  • These metrics aid clinicians in complementing other data for treatment decisions.