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iwCLL 2025 | Analysis of GAIA/CLL13: the role of NGS-based MRD assessment after ven-based 1L combinations for CLL
The Phase III GAIA/CLL13 trial (NCT02950051) investigated venetoclax (ven)-based combination therapies in the first-line (1L) setting for patients with chronic lymphocytic leukemia (CLL). In this video, Moritz Fürstenau, MD, University Hospital of Cologne, Cologne, Germany, shares the findings of a prospective analysis of data from this trial, highlighting the role of next-generation sequencing (NGS)-based measurable residual disease (MRD) assessment in this patient population. Dr Fürstenau notes that patients categorized as having undetectable MRD by conventional flow cytometry who had low-level MRD positivity by NGS had significantly shorter progression-free survival (PFS) compared to those with true undetectable MRD by NGS, demonstrating the prognostic value of NGS-based MRD assessment. This interview took place at the biennial International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2025 in Krakow, Poland.
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Transcript
In the GAIA trial or in the CLL13 trial, in which we tested different venetoclax-based treatments in patients with treatment-naive CLL, we did not only use conventional MRD assessment by flow cytometry, but what we did is we also used a more sensitive method, the NGS-based MRD assessment using a EuroClonality NGS assay. And I think we had roughly 800 patients at each time point assessed by NGS as well...
In the GAIA trial or in the CLL13 trial, in which we tested different venetoclax-based treatments in patients with treatment-naive CLL, we did not only use conventional MRD assessment by flow cytometry, but what we did is we also used a more sensitive method, the NGS-based MRD assessment using a EuroClonality NGS assay. And I think we had roughly 800 patients at each time point assessed by NGS as well. And we found different things. The first thing we found was that the MRD or the undetectable MRD rates below 10 to the minus 6 were very high in the Ven-Obi and the Ven-Obi-ibrutinib arm. I think in both arms we had roughly two-thirds of the patients who had undetected MRD below 10 to the minus 6. Whereas in the chemoimmunotherapy arm and venetoclax rituximab, we only saw 20 to 30% in that range. And we then wanted to know whether the MRD level after treatment correlated with progression-free survival. And we could show that at both time points, at month 15 and also at month 9, when patients were still under treatment, those patients who had undetectable MRD below 10 to the minus 6 had significantly longer PFS compared to those who didn’t. And I think one aspect that we found most interesting is that, and it shows what kind of granularity we gain when we add a more sensitive method, is that a lot of these patients who are actually, by conventional flow cytometry, categorized into undetectable MRD below 10 to the minus 4, actually had low-level MRD positivity between 10 to the minus 4 and 10 to the minus 6, and these patients had significantly shorter PFS compared to those with true undetectable MRD below 10 to the minus 6 by NGS.
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