BRUKINSA demonstrated superior objective response rate by investigator assessment in the planned interim analysisBRUKINSA was associated with a statistically significant lower risk of atrial fibrillation or flutter Company to host investor call and webcast on Friday, June 11 at noon ETCAMBRIDGE, Mass. & BEIJING (BU.
relapsed or refractory chronic lymphocytic leukaemia progression after 12 months vs. 68% for comparators AstraZeneca s Calquence (acalabrutinib), a next-generation, selective Bruton s tyrosine kinase (BTK) inhibitor, has been approved in Japan for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukaemia (CLL) (including small lymphocytic lymphoma [SLL]). The approval by the Japanese Ministry of Health, Labour and Welfare was based on positive results from the ASCEND Phase III trial and a Phase I trial in Japanese patients, showing Calquence monotherapy demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) versus a standard treatment of rituximab, a monoclonal antibody, combined with the physician s choice of idelalisib, a PI3-kinase inhibitor or bendamustine, a chemotherapy.
against ibrutinib in chronic lymphocytic leukaemia Superior safety on key secondary endpoint of atrial fibrillation Positive high-level results from the ELEVATE-RR Phase III trial showed AstraZeneca s Calquence (acalabrutinib) met the primary endpoint demonstrating non-inferior progression-free survival (PFS) for adults with previously treated, high-risk chronic lymphocytic leukaemia (CLL) compared to ibrutinib. The trial also met a key secondary endpoint for safety, showing patients treated with Calquence had statistically significantly lower incidence of atrial fibrillation compared to patients treated with ibrutinib. Atrial fibrillation is an irregular heart rate that can increase the risk of stroke, heart failure and other heart-related complications .
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