ASH 2024 | Bortezomib combined with ibrutinib/rituximab in the first-line treatment of WM

So this study was, as you said, initiated by the European Consortium of Waldenstrom’s Macroglobulinemia. So it’s an academic trial. And it was a single arm Phase II trial, which included 53 patients in treatment naïve Waldenstrom. And the treatment consisted of ibrutinib, rituximab, bortezomib for half a year, then two years ibrutinib rituximab and followed by ibrutinib as a non-fixed duration treatment under progression or non-tolerated toxicity. What we have seen is that this regimen acts very fast, so you see a major effect actually already after three months of treatment. And when we look at the best responses, we achieved a major response of 98% and deep responses of 50%, which we think are very encouraging data. So far after a median follow-up of over 40 months, we only saw one disease progression, actually in a patient which was then confirmed to be not Waldenstrom but marginal zone lymphoma. But what we also have seen is that this trial was actively recruiting during the COVID-19 pandemic. So we had eight fatal infections, six of them being confirmed to be caused by COVID-19. But in summary, I think this trial shows nicely how powerful the combination of BTK inhibitors with proteasome inhibitors are and this is why we initiated another trial of the European consortium where we actually exchanged bortezomib by a second generation proteasome inhibitor, carfilzomib, again combining it with the BTK inhibitor ibrutinib and this study has fully recruited. It’s a randomized Phase II study of the European Consortium which compares carfilzomib, ibrutinib versus ibrutinib.

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