Association Between Progression-Free Survival and Overall Survival in Mantle Cell Lymphoma: A Trial-level Surrogate Endpoint Analysis
In lymphoma trials, progression-free survival alone may not reliably predict overall survival, refining how researchers design studies and regulators evaluate new drugs.
This systematic review of 16 phase III MCL trials (n=5996) found that PFS correlates moderately with OS (R2=0.75) but requires a large PFS benefit (STE: HR≤0.59) to confidently predict OS improvement, limiting its utility as a surrogate in modest-benefit trials. These findings have direct implications for MCL trial design and regulatory approval pathways.
What the study was
- Study design
- Systematic review + weighted linear regression (surrogate endpoint analysis)
- Population
- Phase III MCL clinical trials; 16 trials, 19 treatment comparisons, 5996 patients
- Sample size
- 5996
- Category
- Treatment Innovation
- Maturity
- Validated
- Journal
- Clinical Lymphoma Myeloma and Leukemia
Why it surfaced
Clinically important for MCL trial design and drug approval. Meta-analysis from Brown University group. R2=0.75 moderate surrogacy is relevant for interpreting current and upcoming MCL trials. Scored 6.
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