ASH 2024 | The CRISTALLO study: obinutuzumab combined with venetoclax in previously untreated CLL

We had the opportunity to present the results of the CRISTALLO study. CRISTALLO was a study that was designed to complement the German CLL13 study. This looked at patients with previously untreated CLL and excluded those patients with TP53 abnormalities. Patients were randomly assigned to either the combination of obinutuzumab with venetoclax or investigator’s choice chemotherapy which could be either FCR or bendamustine rituximab. The primary endpoint of this study was MRD negativity and the reason we did this was with a goal to get MRD information into the prescribing information for the obinutuzumab venetoclax regimen. For a variety of FDA regulatory reasons that is not going to be done as a result of this study however we’re pleased to show that the MRD negativity 10 to the negative fourth by next generation PCR sequencing was 81% for patients treated with obinutuzumab venetoclax. This was a statistically significant improvement over either FCR or BR and certainly statistically significant improvements over the integrated control arm. The safety effect profile was very consistent with what’s been seen before There was no TLS associated with the initiation of venetoclax. All TLS that did occur was laboratory TLS and occurred during the obinutuzumab pre-treatment prior to venetoclax. So what we can see is very deep response, 10 to the negative fourth. Because we did this by next generation sequencing, we could look at 10 to the negative fifth and 10 to the negative sixth. And we really do get very deep responses, considerably deeper than those shown with traditional chemoimmunotherapy. This is an approved regimen in the U.S. And I think that this adds to the confidence that our patients could receive this fixed-duration therapy and derive significant long-term benefit.

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