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EHA 2026 | Dose-escalation results from the BELLWAVE-010 study of nemtabrutinib plus venetoclax in R/R CLL
Paolo Ghia, MD, Vita-Salute San Raffaele University, Milan, Italy, discusses the results from the dose-escalation portion of the BELLWAVE-010 study (NCT05947851), which is evaluating the combination of the third-generation BTK inhibitor nemtabrutinib and venetoclax in relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL). Dr Ghia highlights that the results are encouraging reassuring results, with no unexpected toxicity and high response rates at both doses evaluated. This interview took place at the 31st Congress of the European Hematology Association (EHA) in Stockholm, Sweden.
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Transcript
The BELLWAVE-010 study is a study exploring in the relapsed refractory setting the combination of a third generation BTK inhibitor named nemtabrutinib together with Venetoclax, so a combination of a BTK with a BCL2 inhibitor, in the relapsed refractory setting. And in fact it is compared to Venetoclax plus Rituximab, which is the typical standard of care fixed-duration treatment in the relapsed refractory setting...
The BELLWAVE-010 study is a study exploring in the relapsed refractory setting the combination of a third generation BTK inhibitor named nemtabrutinib together with Venetoclax, so a combination of a BTK with a BCL2 inhibitor, in the relapsed refractory setting. And in fact it is compared to Venetoclax plus Rituximab, which is the typical standard of care fixed-duration treatment in the relapsed refractory setting. And BELLWAVE-010 is, as I said, a randomized study, but here we are presenting the phase one of the study, which is the dose escalation portion of the study, where we are exploring two different doses, 45 mg and 65 mg of mentabrutinib together with Venetoclax. And the results are very reassuring. We don’t see any unexpected toxicity. And also in terms of efficacy, we have 100% of responses with the 45 mg dose and 88% with the 65 mg dose for the simple reason that two patients did not yet achieve enough time of follow-up to be assessed for a response. So everything is going well and therefore we will see the next phase of the enrollment of patients in the randomized phase.
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