AstraZeneca Reports Results of Calquence (acalabrutinib) in P-III Head-to-Head ELEVATE-RR Trial for Chronic Lymphocytic Leukemia

June 7, 2021 Auto Bot AstraZeneca, Calquence, Clinical Trials 0

Shots:

  • The P-III head-to-head ELEVATE-RR trial evaluating Calquence (100mg, PO, bid) vs ibrutinib (420mg, PO, qd) in a ratio (1:1) in 533 patients with previously treated CLL
  • The trial met its 1EPs i.e PFS non-inferiority with an m-PFS of 38.4 mos. @median follow up (40.9mos.). The 2EPs include lower incidence of all-grade atrial fibrillation (9.4% vs 16.0%), safety and tolerability were consistent with the known profile of Calquence, mOS was not reached
  • Additionally, P-III ELEVATE-TN trial showed strong PFS benefit of therapy as combination or as monothx. and favorable tolerability through 4 yrs. The results of both trials were presented at ASCO2021

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