ASH 2025 | Nemtabrutinib plus venetoclax in R/R CLL: dose escalation and confirmation in the BELLWAVE-010 trial

The BELLWAVE-010 trial is a trial that is assessing… is divided in two phases, in two parts. The overall goal of the study is to compare Nemtabrutinib, so a third generation non-covalent BTK inhibitor, together with Venetoclax and compare it to the gold standard in the relapsed/refractory setting, which is Venetoclax plus Rituximab. And before doing that, before enrolling patients in this phase of the study, there is another phase of the study where we assessed the tolerability of the combination and also we tried to find the correct dose of the combination. So Nemtabrutinib plus Venetoclax, Nemtabrutinib in two different doses, 45 and 65 milligrams, and we enrolled patients and showed that indeed both doses of Nemtabrutinib together with Venetoclax are effective. We have 100 percent oral response with the 45 milligrams already and 88% with the 65 mg level. With the 65 mg level, there has been two dose-limiting toxicities. One patient died also of pneumonia that you might expect, risk of infection is inherent to the fact that these patients are relapsed/refractory with many previous lines of therapy. So the first phase of the study is going to assess the final dose so that we can move to the randomized part between Nemtabrutinib and Venetoclax versus Venetoclax plus Rituximab. But the combination is feasible and it’s very effective with 100% of responses, 13% complete responses even in the 45 milligram dose.

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