MURANO: a robust, randomized, multicenter, open-label, phase 3 study evaluating the efficacy and safety of VEN+R vs BR in CLL patients who received at least 1 prior therapy 1

  • IRC-assessed PFS was the basis for FDA approval of VEN+R 1
  • Key secondary endpoints were ranked for hierarchical testing as: (1) IRC-assessed CR rate, (2) IRC-assessed ORR, and (3) OS. Because the study did not reach significance at the first key secondary endpoint (IRC-assessed CR rate), the remaining key secondary endpoints could not be tested for statistical significance 5
  • Select inclusion criteria: ≥18 years of age, 1-3 prior lines of therapy, including at least one chemo-containing regimen, and prior bendamustine only if DoR ≥24 months 4
  • Stratification was by 17p deletion status, risk status, and geographic region 4

*From Cycle 1, Day 1, in absence of disease progression or unacceptable toxicity.
28-day cycle.
Patients were characterized as having either high-risk or low-risk CLL. High-risk CLL was defined as 17p deletion or no response to front-line chemotherapy-containing regimen or relapsed ≤12 months after chemotherapy or within 24 months after chemoimmunotherapy. 5

BR=bendamustine + rituximab; CLL=chronic lymphocytic leukemia; R/R=relapsed/refractory; IV=intravenous; IRC=independent review committee; INV=investigator; FDA=US Food and Drug Administration; CRi=complete remission with incomplete marrow recovery.