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ASH 2025 | MRD-guided treatment with sonrotoclax plus obinutuzumab in treatment-naive CLL: BGB-11417-101
Marc Hoffman, MD, University of Kansas Medical Center, Kansas City, KS, shares initial results from the Phase I/Ib BGB-11417-101 study (NCT04277637) of sonrotoclax plus obinutuzumab in patients with treatment-naive chronic lymphocytic leukemia (CLL). Dr Hoffman highlights that the study used measurable residual disease (MRD) status to guide treatment discontinuation, with follow-up ongoing to assess progression-free survival rates. This interview took place at the 67th ASH Annual Meeting and Exposition, held in Orlando, FL.
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Transcript
So this was an extension off of the early phase data with sonrotoclax. So there was the initial dose escalation and dose expansion phases with the drug as a single agent. And then there were multiple different cohorts in treatment naive CLL looking at sonrotoclax in combination with a variety of other drugs. So the data that I presented, or I should say I’m about to present, are with obinutuzumab and sonrotoclax, which is an extension...
So this was an extension off of the early phase data with sonrotoclax. So there was the initial dose escalation and dose expansion phases with the drug as a single agent. And then there were multiple different cohorts in treatment naive CLL looking at sonrotoclax in combination with a variety of other drugs. So the data that I presented, or I should say I’m about to present, are with obinutuzumab and sonrotoclax, which is an extension. It’s a very similar design to the backbone of obinutuzumab and venetoclax used for CLL14. So folks that are familiar with that will recognize it’s a six-month course of obinutuzumab. In this particular study, it was an MRD-adapted endpoint. So rather than being one year of venetoclax. It was 15 months of sonrotoclax. And then in patients who had undetectable MRD, they were eligible to discontinue. The interesting aspect of the study was that among all of the patients that enrolled, there were two patients who had very early development of Richter syndrome. In every single other patient, they all achieved undetectable MRD to at least 10 to the minus four. And so we had essentially an MRD evaluable population, a 100% rate of undetectable MRD to at least 10 to the minus 4. And so we had essentially in the MRD evaluable population, a 100% rate of undetectable MRD. So all of those patients were able to successfully discontinue therapy. They’re currently in follow-up to figure out what the PFS outcomes will be. The events were pretty much as expected in terms of adverse events. There were two TLS events during the obinutuzumab phase, and there were no tumor lysis events seen at all during sonrotoclax escalation on any of the different protocols on which it was escalated. There was some treatment emergent neutropenia which is quite common with this regimen but which was quite easy to manage with growth factor and did not result in a lot of treatment discontinuations or dose reductions.
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