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EHA 2024 | Results of a Phase I study of sonrotoclax for the treatment of R/R Waldenström’s macroglobulinemia
Chan Cheah, MBBS, Linear Clinical Research and Sir Charles Gairdner Hospital, Perth, Australia, outlines the findings of a Phase I study (NCT04277637) of sonrotoclax, a new BCL2 inhibitor, in 20 patients with relapsed/refractory (R/R) Waldenström’s macroglobulinemia (WM). In the doses explored, the agent was active and well-tolerated. Most patients had a partial or very good partial response (VGPR), with a few achieving stable disease. Sonrotoclax had the expected safety profile of a BCL2 inhibitor, and the most common adverse events (anemia and COVID-19) very rarely led to treatment discontinuation. The agent will now be explored further in a Phase II study. This interview took place at the 29th Congress of the European Hematology Association (EHA) in Madrid, Spain.
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Transcript
Yes, sonrotoclax is a new next-generation BCL-2 inhibitor. It’s basically used in a variety of B-cell malignancies. And at this meeting we’re presenting Phase I data in Waldenstrom’s macroglobulinemia, which is a subtype of B-cell lymphoma.
20 patients have been treated and the drug has been active and well tolerated...
Yes, sonrotoclax is a new next-generation BCL-2 inhibitor. It’s basically used in a variety of B-cell malignancies. And at this meeting we’re presenting Phase I data in Waldenstrom’s macroglobulinemia, which is a subtype of B-cell lymphoma.
20 patients have been treated and the drug has been active and well tolerated. I mean, I think that the doses that have been explored have ranged from essentially 20 up to 640mg. And during that dose escalation period, we’ve seen the response rates to be pretty reasonable, the majority of patients have had a response. Most of these have been partial and very good partial responses, with a few patients having stable disease. But all in all, the response rates have been quite encouraging.
The safety profile is as you would expect for a BCL-2 inhibitor and nothing terribly unexpected.
There’s the usual ramp up dosing. There hasn’t been TLS seen. The most common adverse events have been anemia and COVID-19, but they’ve very rarely led to treatment discontinuation. So a Phase II monotherapy study has just opened, and we’ll be exploring this further.
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