The MURANO study: final analysis and retreatment/crossover substudy results of VenR for patients with relapsed/refractory CLL

• DOI: 10.1182/blood.2024025525
• Publication Date: 2025-02-26T17:12:07Z
• Authors: Arnon P. Kater; Rosemary Harrup; Thomas J. Kipps; Barbara Eichhorst; Carolyn J. Owen; Sarit Assouline; Nicole Lamanna; Tadeusz Robak; Javier de la Serna; Ulrich Jaeger; Guillaume Cartron; Marco Montillo; Clemens Mellink; Anton W. Langerak; Brenda Chyla; Relja Popovic; Yanwen Jiang; Rosemary Millen; Marcus Lefebure; Maria Thadani-Mulero; Michelle Boyer; John F. Seymour
• Keywords: Bendamustine; Refractory (planetary science); Progression-free survival; Tolerability

Fixed-duration venetoclax-rituximab (VenR) in patients with relapsed/refractory chronic lymphocytic leukemia (CLL) the phase 3 MURANO trial (NCT02005471) resulted superior progression-free survival (PFS) and overall (OS) vs bendamustine-rituximab (BR). We report final analyses of (median 7 years follow-up). Patients were randomized to VenR (venetoclax 400 mg daily for 2 plus monthly rituximab 6 months; n = 194) or BR (6 195). In a substudy, progressive disease (PD) received as retreatment crossover from BR. At data cut (3 August 2022), median PFS was 54.7 17.0 months Seven-year 23.0%. OS 69.6% 51.0%, respectively. Among VenR-treated undetectable (u) minimal residual (MRD) no PD at end treatment (EOT) (n 83), EOT 52.5 18.0 MRD 35; P < 0.0001). Fourteen had enduring uMRD. Three distinct mutations BCL2 four identified. 25 retreated nine crossed over VenR; 23 27 months, best response rate 72% 89%, combination treatment, following crossover, eight six achieved uMRD, No new safety findings observed. Overall, these support consideration fixed-duration therapy CLL.