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Progression-free survival is strongly associated with overall survival in relapsed/refractory diffuse large B-cell lymphoma in the CAR T-cell era

Year: 2025

Type: article

Abstract: INTRODUCTION: In clinical trials for diffuse large B-cell lymphoma (DLBCL), progression-free survival (PFS) has been used as a validated surrogate endpoint to help expedite drug development and regulatory approval. The advent of chimeric antigen receptor (CAR) T-cell therapies has radically changed the treatment landscape, potentially prolonging post-progression survival and weakening the correlation between PFS and overall survival (OS). This study evaluates the utility of PFS as a surrogate endpoint for OS in relapsed/refractory (R/R) DLBCL in the CAR T-cell era. MATERIALS AND METHODS: A systematic review of Phase 3 randomized clinical trials for R/R DLBCL initiated after 2015 was conducted. A weighted linear regression analysis was performed to assess the correlation between PFS and OS. RESULTS: Six trials, comprising 1577 patients, met the inclusion criteria. Weighted linear regression demonstrated a coefficient of determination (R²) of 0.88 (p = 0.0054), indicating a strong association between PFS and OS in R/R DLBCL trials conducted since the introduction of CAR T-cell therapy. DISCUSSION: These findings provide evidence that PFS remains a valid and strong surrogate endpoint for OS in the contemporary R/R DLBCL treatment landscape. This supports the continued use of PFS as a primary endpoint in regulatory studies for new therapies for R/R DLBCL and provides important information for health policy discussions on drug approval, insurance coverage, and reimbursement decisions for aggressive lymphomas.

Source: Journal of Cancer Policy

DOI: 10.1016/j.jcpo.2025.100699