In the MURANO trial, patients with relapsed and refractory chronic lymphocytic leukemia (CLL) received either 6 cycles of VenR (venetoclax plus rituximab) followed by venetoclax for 2 years total; or chemoimmunotherapy (bendamustine plus rituximab [BR]). A total of 389 patients were enrolled in this study: 194 received VenR and 195 received BR. As of May 2019, all patients had completed treatment with a median follow-up of 48 months since trial enrollment.
With a median follow-up of 22 months since completing treatment with venetoclax, efficacy as measured by progression-free survival (PFS) was significantly longer for VenR compared with BR. Four-year estimates of PFS were 57% for VenR versus 5% for BR. Among 130 patients who received VenR followed by 2 years of venetoclax, 18- and 24-month PFS estimates were 76% and 68%, respectively.
Overall survival (OS) was significantly longer with VenR compared with BR. The 4-year OS rates were 85% and 67%, respectively.
No new serious side effects were observed. Excluding nonmelanoma skin malignancies, 3 second- primary malignancies were detected since the previous update, including 1 patient who received BR and 2 patients who received VenR. There were no new reports of CLL transforming to aggressive lymphoma (Richter’s transformation).
Researchers concluded that 4-year data from the MURANO study showed sustained PFS and OS benefits for VenR compared with chemoimmunotherapy. Patients who received VenR and attained undetectable minimal residual disease showed particularly durable responses. These follow-up data provide further support for use of time-limited VenR in patients with relapsed and refractory CLL.1,2
Abstract 355. ASH 2019.
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