Evaluation of Minimal Residual Disease as a Surrogate for Progression-Free Survival in Hematology Oncology Trials: A Meta-Analytic Review

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Main Authors:	She, Jane, Chen, Xiaofei, Iyengar, Malini, Li, Judy
Format:	Preprint
Published:	2026
Subjects:	Applications
Online Access:	Acceder al recurso
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author	She, Jane Chen, Xiaofei Iyengar, Malini Li, Judy
author_facet	She, Jane Chen, Xiaofei Iyengar, Malini Li, Judy
contents	Traditional health authority approval for oncology drugs is based on a clinical benefit endpoint, or a valid surrogate. In 1992 the FDA created the Accelerated Approval pathway to allow for earlier approval of therapies in serious conditions with an unmet medical need. This is accomplished typically by granting accelerated approval based on a surrogate endpoint that can be measured earlier than a traditional approval endpoint. Minimal residual disease (MRD) is a sensitive measure of residual cancer cells in hematology oncology after treatment, and is increasingly considered as a secondary or exploratory endpoint due to its prognostic potential for traditional clinical trial endpoints such as progression-free survival (PFS) and overall survival (OS). This work aims to evaluate MRD's surrogacy potential across several hematologic cancer indications while keeping the focus on follicular lymphoma (FL), using data from published studies. We examine individual-level and trial-level correlations extracted from previously published studies to elucidate the potential role of MRD in accelerating the drug approval process in hematology oncology trials.
format	Preprint
id	arxiv_https___arxiv_org_abs_2602_21370
institution	arXiv
publishDate	2026
record_format	arxiv
spellingShingle	Evaluation of Minimal Residual Disease as a Surrogate for Progression-Free Survival in Hematology Oncology Trials: A Meta-Analytic Review She, Jane Chen, Xiaofei Iyengar, Malini Li, Judy Applications Traditional health authority approval for oncology drugs is based on a clinical benefit endpoint, or a valid surrogate. In 1992 the FDA created the Accelerated Approval pathway to allow for earlier approval of therapies in serious conditions with an unmet medical need. This is accomplished typically by granting accelerated approval based on a surrogate endpoint that can be measured earlier than a traditional approval endpoint. Minimal residual disease (MRD) is a sensitive measure of residual cancer cells in hematology oncology after treatment, and is increasingly considered as a secondary or exploratory endpoint due to its prognostic potential for traditional clinical trial endpoints such as progression-free survival (PFS) and overall survival (OS). This work aims to evaluate MRD's surrogacy potential across several hematologic cancer indications while keeping the focus on follicular lymphoma (FL), using data from published studies. We examine individual-level and trial-level correlations extracted from previously published studies to elucidate the potential role of MRD in accelerating the drug approval process in hematology oncology trials.
title	Evaluation of Minimal Residual Disease as a Surrogate for Progression-Free Survival in Hematology Oncology Trials: A Meta-Analytic Review
topic	Applications
url	https://arxiv.org/abs/2602.21370

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