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The landscape of checkpoint inhibitors in oncology
Alyson Haslam1, Myung Sun Kim2, Josh Elbaz3
1Department of Epidemiology and Biostatistics, University of California San Francisco Medical, USA.
Background:
Immune checkpoint inhibitor (ICI) therapies have become increasingly popular treatment options for patients with cancer, even for patients in non-metastatic settings. Survival and responses have been reported for individual tumor types, but little is known about these outcomes, collectively. We sought to provide an overview of overall survival (OS) and progression-free survival (PFS) in ICI drugs tested in registration trials.
Methods:
In a cross-sectional analysis of US FDA oncology ICI drug approvals (2011-2023), we searched for supporting ICI registration trials. We characterized these trials, regarding differences in median OS and PFS between patients in intervention and control arm participants in ICI registration trials; percentage of patients who receive ICI crossover; and whether there is correlation between the percentage of crossover and differences in OS or PFS.
Results:
Fifty-six (54.4 %) approvals had trials that reported median OS for both intervention and control arms (median difference was 2.8 months; IQR: 2.2 to 5.0 months). Sixty-five (63.1 %) approvals had trials that reported PFS data for both arms (median of 0.9 months; IQR: -0.2 to 3.0 months). Subsequent therapy was common (median=18.9 %) and was significantly correlated with a higher difference in median OS in all studies with reported differences (R2 =0.15; p = 0.001).
Conclusion:
ICIs are increasingly used in the treatment of cancer, yet the median OS improvement is modest, and many ICIs have not been tested for OS benefit. OS is the outcome most meaningful for patients, and drug regulation should require better testing and reporting of these data.
Insights
Immune checkpoint inhibitors (ICIs) show modest overall survival (OS) benefits in cancer trials, with many lacking OS data. Crossover to subsequent therapies correlates with improved OS differences.
Area of Science:
- Oncology
- Immunotherapy
- Clinical Trials
Background:
- Immune checkpoint inhibitors (ICIs) are increasingly used for cancer treatment, including in non-metastatic settings.
- While responses are known for specific cancers, collective survival outcomes from ICI trials are not well-documented.
Purpose of the Study:
- To provide an overview of overall survival (OS) and progression-free survival (PFS) for immune checkpoint inhibitor (ICI) drugs evaluated in registration trials.
- To analyze differences in OS and PFS between intervention and control arms, assess ICI crossover rates, and explore correlations between crossover and survival outcomes.
Main Methods:
- Cross-sectional analysis of US FDA oncology ICI drug approvals from 2011-2023.
- Characterization of supporting ICI registration trials, focusing on median OS and PFS differences, patient crossover rates, and correlation analysis.
Main Results:
- Median OS difference was 2.8 months (IQR: 2.2-5.0) in 54.4% of approvals with reported OS data.
- Median PFS difference was 0.9 months (IQR: -0.2-3.0) in 63.1% of approvals with reported PFS data.
- Subsequent therapy crossover (median 18.9%) significantly correlated with higher median OS differences (R²=0.15, p=0.001).
Conclusions:
- Immune checkpoint inhibitors (ICIs) offer modest median OS improvements, and many lack OS benefit data.
- Overall survival (OS) is a critical patient outcome, necessitating improved regulatory requirements for testing and reporting.
- Drug regulation should mandate comprehensive OS data collection and reporting for ICI therapies.
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