BeiGene announced the latest clinical trial data on the safety and effectiveness of Baiyueze (Zebutinib) in the treatment of patients with relapsed/refractory B-cell malignancies who are intolerant to BTK inhibitors

BeiGene announced the safety and efficacy results of an ongoing phase 2 trial of the supplement.
And/or a trial of efficacy in patients with B-cell malignancies who are intolerant to Acalabrutinib
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These data have been disclosed at a small oral presentation held today during the 63rd American Society of Hematology (ASH) annual meeting
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A small oral report of the Phase 2 trial of Baiyueze® in the treatment of patients with relapsed/refractory B-cell malignancies who are intolerant to other BTK inhibitors; Abstract No.
1410 This single-arm, open-label, multiple The central phase 2 trial (NCT04116437) evaluated the safety and efficacy of Baiyueze® in patients with previously treated B-cell malignancies who were intolerant to other BTK inhibitors.
The preliminary results were in the 62nd session in December 2020.
Announced at the ASH annual meeting
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The primary safety endpoint was assessed by whether the patient's adverse events (AE) that caused intolerance during the treatment of Ibrutinib and/or Acalabrutinib recurred and whether the severity changed
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Secondary endpoints include the investigator-assessed disease control rate (DCR), overall response rate (ORR), progression-free survival (PFS), and patient-reported treatment outcomes
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A total of 67 patients were enrolled in this trial (57 patients were intolerant to Ibrutinib [Cohort 1], 10 patients were intolerant to Acalabrutinib and/or Ibrutinib [Cohort 2]), including 43 patients with chronic Lymphocytic leukemia (CLL) patients (38 cases in cohort 1 and 5 cases in cohort 2), 11 patients with Waldenstrom's macroglobulinemia (WM) (9 cases in cohort 1 and 2 cases in cohort 2), 7 small Lymphocytic lymphoma (SLL) patients (6 in cohort 1 and 1 in cohort 2), 3 mantle cell lymphoma (MCL) patients (2 in cohort 1 and 1 in cohort 2) and 3 cases of marginal zone Lymphoma (MZL) patients (2 cases in cohort 1 and 1 case in cohort 2)
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Patients who experience significant or persistent side effects during treatment with Ibrutinib and/or Acalabrutinib are considered intolerant, although they receive better care
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Mazyar Shadman, MD, Associate Professor in the Clinical Research Department of the Fred Hutchinson Cancer Research Center, Assistant Professor in the Department of Oncology at the University of Washington School of Medicine, and lead investigator of the trial, said: "BTK inhibitor tolerance remains a major challenge for patients and their doctors.
, Because the interruption or termination of treatment may affect the clinical outcome
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The data of this trial shows that Baiyueze® treatment is well tolerated and is unlikely to cause the recurrence of intolerable AE events that have occurred in previous BTK inhibitor treatments
At the same time, Baiyueze® is also effective in maintaining or improving the remission from baseline at least, which indicates that Baiyueze® may become a treatment option for patients with hematological malignancies who are intolerant to other BTK inhibitor treatments
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" As of The data cut-off date was September 8, 2021.
The median exposure time of Baiyueze® was 11.
1 months (11.
6 months for cohort 1 and 9.
8 months for cohort 2), most of which were treated with Ibrutinib and Acalabrutinib Intolerance events of ”did not recur in patients receiving Baiyueze® treatment, and there was no recurrence of intolerance events of higher severity
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The safety results of the trial included: Baiyueze® was tolerable in 67 patients in the two cohorts, and other safety results included: The investigator evaluated the effectiveness of patients in the two cohorts who received more than 90 days of treatment
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Baiyueze® can effectively maintain remission in at least 60 patients (93.
8% in total, 94.
7% in cohort 1 and 85.
7% in cohort 2), or 41 patients (64.
1% in total, 63.
2% in cohort 1 and 63.
2% in cohort 2).
The response was 71.
4%) improved from baseline; the median time to first response was 2.
96 months (2.
92 months for cohort 1 and 3.
02 months for cohort 2)
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