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Cross sectional analysis of long-term overall survival among patients taking immune checkpoint inhibitor drugs

Alyson Haslam1, Timothée Olivier2, Vinay Prasad1

  • 1Department of Epidemiology and Biostatistics, University of California San Francisco, San Francisco, CA, USA.

Journal of Cancer Policy
|November 21, 2025
PubMed
Abstract

Insights

Few immune checkpoint inhibitor (ICI) oncology trials report long-term survival data. Incentivizing the collection and reporting of this data is crucial for assessing the true value of these transformative cancer therapies.

Area of Science:

  • Oncology
  • Immunotherapy
  • Clinical Trial Analysis

Background:

  • Immune checkpoint inhibitors (ICIs) have revolutionized cancer treatment.
  • However, comprehensive data on long-term survival outcomes from ICI therapies remain limited.
  • Understanding long-term survival is critical for evaluating the full impact of these treatments.

Purpose of the Study:

  • To characterize the availability and patterns of long-term overall survival (OS) data in oncology clinical trials for immune checkpoint inhibitors.
  • To assess the correlation between patient survival metrics and the duration of patient at-risk status in these trials.

Main Methods:

  • A cross-sectional analysis was conducted on US FDA oncology ICI drug approvals from 2011 to 2023.
  • Data from supporting registration trials were examined for participant survival percentages at 12, 24, 36, and 60 months.
  • The American Society of Clinical Oncology (ASCO) Value Framework Tail of the Curve calculation was used, alongside correlation analysis.

Main Results:

  • Out of 88 approvals, only 20 (22.7%) qualified for the ASCO tail of the curve bonus.
  • A significant proportion of studies failed to report OS at key time points: 30.7% at 12 months, 50.0% at 24 months, 68.2% at 36 months, and 88.6% at 60 months.
  • No significant correlation was found between the longest time with 10% of patients at-risk and the difference in survival percentages (R²=0.1, p=0.30). The median longest time with at least 10% of participants at-risk was 30 months.

Conclusions:

  • The majority of registration trials for immune checkpoint inhibitor oncology therapies lack comprehensive long-term overall survival data.
  • There is a need to incentivize the collection and reporting of long-term survival data to better assess the value of these drugs.
  • Improved reporting standards are necessary for a complete understanding of ICI therapy efficacy in the long term.
Keywords:
Checkpoint inhibitorlong-termsurvival

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