Zanubrutinib (3) – Brukinsa®

• Clinical trials
  • The MAGNOLIA trial investigated the efficacy and safety of zanubrutinib in adults with marginal zone lymphoma who had received at least one prior treatment, including at least one CD20-targeted therapy.
  • The uncontrolled Phase I/II clinical study BGB-3111-AU-003 investigated zanubrutinib in patients with B-cell neoplasms.

Adults with marginal zone lymphoma who have received at least one prior course of treatment with an anti-CD20 antibody

• The additional benefit is not proven.
• The results of the single-arm studies MAGNOLIA and BGB-3111-AU-003 are not suitable for assessing additional benefit, as they do not allow for a comparison with the appropriate comparator therapy; consequently, an additional benefit of zanubrutinib is not proven in adults with marginal zone lymphoma who have received at least one prior course of treatment with an anti-CD20 antibody.
• Overall assessment
  • Results from the single-arm studies MAGNOLIA and BGB-3111-AU-003 are available for the assessment of the additional benefit of zanubrutinib in adults with marginal zone lymphoma who have received at least one prior course of treatment with an anti-CD20 antibody.
  • The results of the single-arm studies MAGNOLIA and BGB-3111-AU-003 submitted are not suitable for assessing additional benefit, as they do not allow for a comparison with the appropriate comparator therapy; consequently, the additional benefit of zanubrutinib in adults with marginal zone lymphoma who have received at least one prior course of treatment with an anti-CD20 antibody is not proven.

Courtesy translation only, please refer to the German original.