ERIC 2024 | Barriers to the implementation of MRD-guided treatment into CLL clinical practice

So, I’m part of the session at this meeting to talk about MRD and whether or not MRD is ready for prime time. And I think probably the easy answer is not yet, but we do anticipate that it will eventually make it to general standard of care management of patients. And there’s a few barriers that we need to get past in order for that to happen. One is to have the clinical trial data that supports and demonstrates that treating patients to MRD undetectable status improves their long-term outcome versus treating them to a fixed duration treatment. There are some data that are directing us towards that endpoint, like the FLAIR data and our MD Anderson data where patients received two years of treatment with ibrutinib venetoclax versus one year that was used in GLOW and Captivate. So there are data that clearly support that fixed duration with combined targeted therapy may not be the best approach and that we need to consider treating to MRD undetectable status. But I believe there’s more data that we need to generate that would support using that in the general practice of patient care. And then the other challenge has been the assay to use and access to the assay. So having an appropriate assay that we can easily access as standard of care has been a challenge. In the US, the clonoSEQ assay, which is the NGS-based assay, is the only FDA-cleared assay, although you can obtain flow cytometry. And I think in order to have a standardized FDA-endorsed strategy or label, we’re going to have to use the NGS unless or until flow becomes cleared by the FDA and the data that’s generated with it are acceptable to the FDA. So the assay is sort of a barrier in terms of standard application and then also the data from the clinical trials.