John Pagel, MD, PhD, on Promising Responses Seen With Zanubrutinib Plus Zandelisib for B-Cell Malignancies


Patients with relapsed or regractory B-cell malignancies who were treated with zanubrutinib and zandelisib demonstrated high response rates across several treatment cohorts.

John Pagel, MD, PhD, from the Swedish Cancer Institute, discusses how the combination of zanubrutinib (Brukinsa) and zandelisib has led to positive response rates among patients in all cohorts of a phase 1 study (NCT02914938). A cohort of patients with non-Hodgkin lymphoma (n = 16), including mantle cell lymphoma, experienced a 100% response rate, with 2 patients having a complete response and 14 with partial responses.


There [results in] just 20 patients so far that can be reported on in this very small, early trial. There were 7 in cohort 10A and now 13 and cohort 10B. The outstanding news is that every patient—all 18 of them who had either follicular lymphoma, CLL or SLL, marginal zone lymphoma, or mantle cell lymphoma—had a response. There were 2 patients with diffuse large B-cell lymphoma or a high-grade B-cell lymphoma that did not respond and had discontinuation of therapy or progressive disease. This is a very high objective response rate. It’s quite impressive and it’s quite durable. We have patients approaching 2 years out of follow-up on the combination doing extremely well. What’s most important here is that this appears to not only be a highly efficacious regimen, but also a very well tolerated regimen.

Again, there was a 100% response rate and strong clinical activity in these patients with relapsed or refractory indolent B-cell lymphomas. The follow-up is relatively short, but many of these responses are highly durable with some patients approaching 2 years of treatment. There is an opportunity for this combination regimen to be highly impactful in these patients who have this unmet need with relapsed or refractory B-cell malignancies.


Soumerai J, Jagadeesh D, Salman H, et al. Initial results of the combination of PI3Kδ inhibitor zandelisib (ME-401) and the BTK inhibitor zanubrutinib in patients (pts) with relapsed or refractory (R/R) B-cell malignancies. J Clin Oncol. 39 (supply15): 7553. doi: 10.1200/JCO.2021.39.15_suppl.7553

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