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ASH 2025 | Updated efficacy and safety results of BTK degrader BGB-16673 in R/R CLL: the CaDAnCe-101study
In this video, Constantine Tam, MBBS (Hons), MD, FRACP, FRCPA, Alfred Hospital and Monash University, Melbourne, Australia, presents the updated efficacy and safety results of the BTK degrader BGB-16673 in patients with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL) from the ongoing Phase I CaDAnCe-101 study (NCT05006716). This interview took place at the 67th ASH Annual Meeting and Exposition, held in Orlando, FL.
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Transcript
So the CaDAnCe-101 trial is the first in human phase one study of a new molecule. This is a BTK degrader. So rather than inhibiting BTK, it degrades BTK. And the advantage of this drug is that it’s able to overcome basically most of the mutations that affect earlier generations of BTK inhibitors. So what we have done in this meeting is we’ve updated the results of patients with CLL enrolled in a phase one study...
So the CaDAnCe-101 trial is the first in human phase one study of a new molecule. This is a BTK degrader. So rather than inhibiting BTK, it degrades BTK. And the advantage of this drug is that it’s able to overcome basically most of the mutations that affect earlier generations of BTK inhibitors. So what we have done in this meeting is we’ve updated the results of patients with CLL enrolled in a phase one study. So 68 patients are being treated with CLL. Now these are very heavily pre-treated patients. They have had a median of four lines of therapy. They have failed traditional BTK inhibitors. Some of them have failed both covalent and non-covalent BTK inhibitors. So this is some of them. It’s the third time we are hitting the BTK pathway again. And what we show is that the drug is safe, that there weren’t any unexpected side effects apart from that expected of a normal BTK inhibitor. So despite the degradation mechanism, the side effects are not different. At the recommended phase two dose of 200 milligrams, we had a response rate of 94%, which is maintained amongst those patients who have had pathogenic BTK mutations or 17p. So this drug is able to overcome, it appears, most of the BTK mutations out there. And with, you know, at the median of 18 months, you look at the 18-month progression-free survival, that’s 66%. So most patients are still in remission a year and a half after starting this treatment, despite having been heavily pretreated with normal BTK inhibitors and having mutations. So what this says is that we now have a new molecule that is clearly active, that we can hit the BTK mutation, the BTK pathway three times with a covalent drug, a non-covalent drug, and now a degrader, and we can still get good responses. And the responses seem to be quite durable compared to, let’s say, data on non-covalent BTK inhibitors in a similar setting. So that drug is now in phase three studies, and we’re hoping that the phase three studies will confirm the favorable results of the phase one.
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