Preliminary data from a China-based Phase 1 clinical trial evaluating BeiGene's (NASDAQ:BGNE) BTK inhibitor zanubrutinib in patients with B-cell lymphoma showed a treatment effect. The results were presented at the Annual Meeting of the Chinese Society of Clinical Oncology in Xiamen.
34 patients were evaluable for response. The overall response rate (ORR) in nine patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) was 100%, including two complete responders. In two patients with mantle cell lymphoma (MCL), there was one complete responder and one with stable cancer. In two patients with Waldenström macroglobulinemia (WM), there was one partial responder and one with stable cancer. Of the 26 patients with follicular lymphoma (FL), the ORR was 42% (n=11/26), including two complete responders. In five patients with marginal zone lymphoma (MZL), there were three patients with stable cancer and two who were not evaluable.
No dose-limiting toxicities or new safety signals were observed. The most common adverse events were decreased neutrophil count (50%), anemia (32%), upper respiratory tract infection (25%), decreased white blood cell count (25%), decreased platelet count (23%), rash (23%), hematuria (blood in the urine) (20%) and hyperuricemia (excess uric acid in the blood) (20%).
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