AbbVie announced the first presentation of efficacy and safety results from MURANO, an international, multicenter, open-label, randomized Phase 3 study of VENCLEXTA/VENCLYXTO (venetoclax) in combination with Rituxan (rituximab) compared with bendamustine in combination with Rituxan in patients with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL).
Investigator-assessed results showed that patients with R/R CLL achieved significantly prolonged median progression-free survival (PFS) with VENCLEXTA/VENCLYXTO in combination with Rituxan [median PFS, not reached], compared with bendamustine in combination with Rituxan [median PFS, 17.0 months; hazard ratio, 0.17; 95% CI, 0.11–0.25; P<0.0001]. Twenty-four month PFS estimates were 84.9 percent and 36.3 percent, respectively.1 Independent Review Committee (IRC)-assessed PFS showed similar results.1 Additionally, consistent improvement in PFS was observed across the patient subgroups assessed in the trial, including patients with 17p deletion [hazard ratio 0.14; 95% CI, 0.06–0.33]. VENCLEXTA/VENCLYXTO is being developed by AbbVie and Roche. It is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the U.S.
At the time of the interim analysis, safety data were consistent with the known safety profiles of the medicines.
"The data from the MURANO trial represents the next evolution in a potential treatment option for patients with relapsed/refractory CLL, an indication for which we received Breakthrough Therapy Designation," said Michael Severino, M.D., executive vice president, research and development, and chief scientific officer, AbbVie. "We are proud to present these findings at the ASH annual meeting and are working closely with regulatory authorities to bring this combination therapy to appropriate patients as soon as possible."
The data also serves as the Phase 3 confirmatory study requested by the U.S. Food and Drug Administration (FDA) when VENCLEXTA was granted accelerated approval on April 11, 2016.2 Health authority regulatory submissions of VENCLEXTA/VENCLYXTO in combination with Rituxan are underway.