The CDDF Minimal Residual Disease Working Group will bring together academia, regulators, payers and industry for an opportunity to engage on the concerted development of Minimum Residual Disease (MRD) as a validated tool for drug development and treatment decision.
The recently published ‘Concept paper on the need to revise Condition – Specific guidance, Appendix 4 to the guideline on the evaluation of anticancer medicinal products in man’ addresses the use of minimal residual disease (MRD) as a clinical endpoint in multiple myeloma (MM) clinical studies. Advances in MM therapy have significantly improved PFS and OS times meaning that clinical trials with survival endpoints take many years to complete. Despite these advances, MM is still incurable and the majority of patients relapse. A surrogate endpoint for survival could radically reduce the read-out times for MM trials and facilitate earlier patient access to novel therapies. Therefore the objectives of the meeting are to establish how MRD negativity might be adopted as a surrogate or intermediate endpoint for PFS (+/-OS) in clinical trials.
The long term goal of the CDDF Minimum Residual Disease Working Group would aim for MRD to become a tool/study endpoint that is recognized by regulators, as exemplified by MRD based labels. By working together, the Working Group will create the right platforms and develop the tool for MRD data to be considered an important consideration in treatment decisions given MRD data in the context of advancing of the standard of care. The overarching objective is to aid timely access to drugs for the patient against high standards set by the community.
Who should attend?
Oncologists, scientists, government officials (EMA, FDA, HTA representatives), pharmaceutical industry, assay developers, patient representatives, policymakers.