ASH 2019: Extended Analysis of MURANO Trial of Venetoclax/Rituximab in CLL
Posted: Friday, January 3, 2020
According to research presented at the 2019 American Society of Hematology (ASH) Annual Meeting & Exposition in Orlando, Florida (Abstract 355), patients with relapsed or refractory chronic lymphocytic leukemia (CLL) experienced superior survival outcomes after treatment with venetoclax/rituximab compared with those who received treatment with bendamustine/rituximab. These findings come from an extended follow-up evaluation of the phase III MURANO trial, which previously reported that venetoclax/rituximab was associated with improved progression-free survival.
“Four-year data from MURANO demonstrate sustained [progression-free survival] and [overall survival] benefits with [venetoclax/rituximab] versus [bendamustine/rituximab],” concluded Arnon P. Kater, MD, PhD, of the University of Amsterdam, and colleagues. “These follow-up data provide further support for the application of time-limited [venetoclax/rituximab] in relapsed/refractory CLL.”
The study included 389 patients who were randomly assigned to receive either 6 cycles of venetoclax/rituximab followed by 400 mg of venetoclax each day for 2 years total (n = 194) or 6 cycles of bendamustine/rituximab (n = 195). At a median follow-up of 22 months after the cessation of venetoclax treatment, the estimated 4-year progression-free survival with venetoclax/rituximab remained superior to that with bendamustine/rituximab (57.3% vs. 4.6%). Specifically, within the venetoclax group, patients who completed a full 2 years of venetoclax (n = 130) had progression-free survival estimates of 75.5% for 18 months and 68.0% for 24 months.
Patients receiving venetoclax also continued to show superior overall survival despite 73% of patients in the bendamustine group undergoing additional treatment after disease progression, 79% of whom received targeted treatment. The estimated 4-year overall survival rate was 85.3% with venetoclax versus 66.8% with bendamustine. No new serious adverse events were reported during the extended follow-up, although two patients receiving venetoclax and one patient receiving bendamustine developed second primary tumors.
Disclosure: For full disclosures of the study authors, visit ash.confex.com.