CHICAGO–Complete response rate at 30 months is a surrogate endpoint for progression-free survival in first-line follicular lymphoma trials and can be used to expedite therapeutic development, data presented at the 2015 American Society of Clinical Oncology (ASCO) annual meeting have shown.
“Follicular lymphoma is an indolent type of non-Hodgkin lymphoma that originates from malignant transformation of follicle center B cells,” said Daniel J. Sargent, PhD, principal investigator and professor of biostatistics and oncology at the Mayo Clinic in Rochester, MN.
Currently, progression-free survival is the standard endpoint for new drug approvals in first-line treatment of follicular lymphoma; however median progression-free survival can be greater than 7 years.
Complete response rate at 30 months may therefore be used as an earlier endpoint to predict progression-free survival.
“Our objective was to establish a surrogate endpoint for progression-free survival in first line follicular lymphoma to reduce duration of clinical trials and expedite patient access to effective new therapies,” Dr. Sargent said.
To do so, research collaborators created the Follicular Lymphoma Analysis of Surrogate Hypotheses (FLASH) Group.
For the IPD meta-analysis, researchers analyzed data from 13 randomized first line trials all published in the first decade of the 2000s that included 3,837 patients with follicular lymphoma.
Results showed that treatment effects on the complete response rate at 30 months predict effects on progression-free survival in patients with previously untreated follicular lymphoma. Numerous sensitivity and surrogacy analyses supported those results.
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Researchers found that a minimum 10% absolute improvement in complete response rate at 30 months over a control complete response rate at 30 months of 50% correlated with significant improvement in progression-free survival.
Dr. Sargent concluded, “Prinicipal candidate CR30 met the surrogacy qualification criteria for progression-free survival…CR30 may be considered an appropriate primary endpoint in future first-line follicular lymphoma studies.”
- Sargent DJ, Shi Q, De Bedout S, et al. Evaluation of complete response rate at 30 months (CR30) as a surrogate for progression-free survival (PFS) in first-line follicular lymphoma (FL) studies: Results from the prospectively specified Follicular Lymphoma Analysis of Surrogacy Hypothesis (FLASH) analysis with individual patient data (IPD) of 3,837 patients (pts). J Clin Oncol. 2015;33:(suppl; abstr 8504).