John F. Seymour, MBBS, PhD
Targeted agents are here to stay when it comes to chronic lymphocytic leukemia (CLL), said John F. Seymour, MBBS, PhD. Additionally, combination therapies, as demonstrated by the phase III MURANO trial, can achieve deeper responses and enable the use of time-limited therapy in this patient population.
, Seymour discussed the clinical implications of the MURANO trial and highlighted the feasibility for time-limited therapy and its benefits for patients with CLL.
OncLive: How was the MURANO trial designed?
: MURANO [was a trial with] a superiority design. It was randomized [trial that tested the venetoclax combination] head-to-head in a 1:1 fashion against BR. Initially, there was no crossover built into the study, so patients who progressed on either arm then received treatment at physician’s discretion.
The trial has now been modified such that there is a crossover. Patients progressing on BR will receive venetoclax/rituximab, and those patients progressing after withdrawal of venetoclax will be retreated with venetoclax/rituximab. That amendment will give us more detail about subsequent therapy, and particularly, response to retreatment with venetoclax-based therapy.
What were the results presented at the 2018 ASH Annual Meeting?
The results of the MURANO study at initial analysis had been published in the New England Journal [of Medicine] in 2018. The superiority [data]—in terms of PFS and higher rates of uMRD—for the venetoclax combination have already been established and published.
The main emphasis of the presentation [at the 2018 ASH Annual Meeting] was the outcome of patients in the venetoclax/rituximab arm after drug cessation. We now have nearly 12 months of median follow-up data. In all patients, regardless of MRD status, who stopped venetoclax at the 2-year period, the likelihood of PFS 1 year later is 87%. This shows that as a general treatment strategy, time-limited therapy with drug cessation is feasible and safe.
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