Date: 2017-01-25
Type of
information: Initiation of the trial
phase: 3
Announcement: initiation of the trial
Company: BeiGene (China)
Product: BGB-3111
Action
mechanism:
- kinase inhibitor/Bruton tyrosine kinase inhibitor. BGB-3111 is an investigational, oral, highly selective and potent inhibitor of Bruton tyrosine kinase (BTK). Bruton tyrosine kinase (BTK), a member of the TEC family of kinases, is a signaling molecule positioned within the B-cell receptor signaling cascade. BTK is predominantly expressed in B lymphocytes at various stages of development. Activation of BTK in B cells initiates a series of signaling events that leads to subsequent NF-?B activation and the expression of genes involved in proliferation and survival. Several BTK inhibitors have demonstrated sustained antitumor responses as a single agent in patients with B-cell malignancies
Disease: Waldenström’s macroglobulinemia
Therapeutic
area: Cancer - Oncology
Country: Australia, Belgium, Germany, Greece, Italy, Netherlands, Poland, Spain, Sweden, UK, USA
Trial
details:
- This Phase III trial is designed to determine whether BGB-3111 is superior to ibrutinib based upon the combined rate of complete responses (CRs) and very good partial responses (VGPRs), response levels which are correlated with improved outcomes in Waldenström’s macroglobulinemia patients who require therapy. The study will enroll relapsed / refractory or treatment-naïve WM patients who are inappropriate for chemo-immunotherapy.
- At the time of enrollment, patients will be tested for mutation status of the MYD88 gene and assigned accordingly to one of two trial cohorts. The first cohort will enroll approximately 150 patients with MYD88 mutations, which are characteristic of WM and present in >90% of cases. These patients will be randomized in a 1:1 ratio to receive either BGB-3111 160 mg orally twice daily (BID) or ibrutinib 420 mg once daily (QD) until progression.
- The trial’s primary endpoint is combined rate of CRs and VGPRs. A key secondary endpoint is major response rate (MRR, defined as partial response or better), which will be hierarchically tested for non-inferiority followed by superiority. Other secondary endpoints will include progression-free survival, duration of response, and symptom resolution. The randomization will be stratified by CXCR4 mutational status and number of lines of prior therapy.
- Patients with MYD88 wildtype status will be enrolled in a second cohort and will receive BGB-3111 160 mg BID until progression. Patients will be assessed for the combined rate of CRs and VGPRs, MRR, and safety. (NCT03053440)
Latest
news:
- • On January 25, 2017, BeiGene announced the initiation of a global, randomized Phase III trial of its investigational Bruton’s Tyrosine Kinase (BTK) inhibitor BGB-3111 in patients with Waldenström’s macroglobulinemia. The study is designed to determine whether the quality of response with BGB-3111 in Waldenström’s macroglobulinemia is superior to that of ibrutinib, the currently approved BTK inhibitor. Approximately 170 patients are expected to be enrolled at clinical sites in North America, Europe, Australia, and New Zealand. Beigene also looks forward to initiating pivotal studies for BGB-3111 in China in the first half of 2017.
Is
general: Yes
