Open-label, randomized study demonstrates VENCLEXTA™/VENCLYXTO™ safety and efficacy.
Based on results from its open-label, randomized Phase III MURANO trial, AbbVie announced its VENCLEXTA™/VENCLYXTO™ (venetoclax) in combination with Rituxan® (rituximab) met its primary endpoints and demonstrated its safety and efficacy compared with bendamustine in combination with Rituxan in patients with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL).
The results showed that people suffering from R/R CLL experienced a longer median progression-free survival (PFS) with AbbVie’s combination as opposed to the bendamustine combination. According to AbbVie, consistent improvement in PFS was observed across patient subgroups assessed in the trial and that at the time of interim analysis, safety data was consistent with the known safety profiles of the individual pharmaceuticals being combined.
Michael Severino, Chief Scientific Officer and an Executive Vice President for AbbVie’s R&D effort explained "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. 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."
According to AbbVie, a total of 389 R/R CLL patients who had already received one to three prior therapeutic treatments were enrolled in the international, multicenter trial. "This primary analysis of the MURANO trial showed a significant improvement in PFS with VENCLEXTA/VENCLYXTO and Rituxan versus bendamustine and Rituxan, with consistent results in all patient subsets assessed," said Lead MURANO Trial Investigator John Seymour, of the Peter MacCallum Cancer Centre & Royal Melbourne Hospital in Australia.
"Based on the efficacy and safety results of this trial, the VENCLEXTA/VENCLYXTO and Rituxan combination has the potential to offer a new chemotherapy-free regimen for patients with relapsed/refractory CLL. We continue to monitor safety and efficacy in trial patients to gain further data and information,” concluded MacCallum.
