|The following article features coverage from the American Society of Hematology 2020 meeting. Click here to read more of Cancer Therapy Advisor‘s conference coverage.|
Patients with relapsed/refractory chronic lymphocytic leukemia (CLL) treated with venetoclax-rituximab had sustained progression-free and overall survival compared with bendamustine-rituximab, according to updated 5-year results of the MURANO trial (ClinicalTrials.gov Identifier: NCT02005471).
“A significant proportion of patients remain with undetectable MRD at this follow-up,” said Arnon P. Kater, MD, PhD, of Cancer Center Amsterdam, who presented the update at the virtual 62nd American Society of Hematology (ASH) Annual Meeting and Exposition
The MURANO trial randomly assigned 389 patients to receive venetoclax-rituximab or bendamustine-rituximab. Previously published results showed that deep responses with undetectable minimal residual disease (MRD) were associated with superior progression-free survival of venetoclax-rituximab.
At the meeting, Dr Kater presented long-term results of MRD kinetics and updated efficacy outcomes.
With a median follow-up of about 60 months, the progression-free survival benefit was sustained, according to Dr Kater. Median progression-free survival was 53.6 months for venetoclax-rituximab compared with 17 months for bendamustine-rituximab (hazard ratio [HR], 0.19; 95% CI, 0.15-0.26; P <.0001).
Median overall survival has not been reached for either arm. The 5-year estimated overall survival rate was 82.1% for venetoclax-rituximab and 62.2% for bendamustine-rituximab (HR, 0.40; 95% CI 0.26-0.62; P <.0001).
No new safety signals were identified with this efficacy update, Dr Kater said.
Patients treated with venetoclax-rituximab that reached end of treatment without progressive disease and had undetectable MRD had improved progression-free survival and overall survival compared with those with MRD.
The 3-year post–end of treatment progression-free survival estimate was 61% for undetectable-MRD compared with 41% for low-MRD positivity, and 8.3% with high-MRD positivity rates. The 3-year post–end of treatment survival estimate was 95.3% for patients with undetectable MRD compared with 85.0% for MRD positivity.
Of patients that achieved undetectable MRD at end of treatment, baseline presence of del(17p), genomic complexity, and unmutated immunoglobin heavy chain gene were all associated with a greater risk of MRD conversion and subsequent progressive disease.
“Sustained undetectable MRD, progression-free survival, and overall survival benefits provide further support for the use of fixed duration of venetoclax-rituximab in patients with relapsed/refractory CLL,” Dr Kater said.
Disclosures: Some of the presenters disclosed financial relationships with the pharmaceutical industry and/or the medical device industry. For a full list of disclosures, please refer to the presentation abstract.
Read more of Cancer Therapy Advisor‘s coverage of the ASH 2020 meeting by visiting the conference page.
Kater AP, Kipps TJ, Eichorst B, et al. Five-year analysis of Murano study demonstrates enduring undetectable minimal residual disease (uMRD) in a subset of relapsed/refractory chronic lymphocytic leukemia (R/R CLL) patients (pts) following fixed-duration venetoclax-rituximab (VenR) therapy (Tx). Presented at: the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition; December 5-8, 2020. Abstract 215.