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Combination of AbbVie's venetoclax and Rituxan succeeds in phase 3 R/R CLL trial

PBR Staff Writer Published 13 December 2017

AbbVie and Roche’s Venclexta/Venclyxto (venetoclax) in combination with MabThera/Rituxan (rituximab) succeeded in a phase 3 trial in patients with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL) by meeting the primary endpoint.

The late-stage study, dubbed MURANO, demonstrated that Venclexta/Venclyxto, an oral B-cell lymphoma-2 (BCL-2) inhibitor in combination with MabThera/Rituxan cut down the risk of disease progression or death by 83% in comparison to a standard of care regimen in previously treated CLL.

MURANO evaluated the AbbVie and Roche drug combination therapy against bendamustine in combination with MabThera/Rituxan in 389 patients who had one to three prior therapies.

Venclexta/Venclyxto in combination with MabThera/Rituxan was shown to have achieved significant median progression-free survival (PFS) compared with bendamustine in combination with MabThera/Rituxan.

The primary endpoint of the trial was investigator-assessed PFS while secondary endpoints were Independent Review Committee (IRC)-assessed PFS, PFS in patients with 17p deletion, best overall response, and nodular partial response [nPR] among others.

Roche chief medical officer and global product development head Sandra Horning said: “The MURANO study results indicate that Venclexta/Venclyxto plus MabThera/Rituxan has the potential to provide an important new chemotherapy-free option for people with previously treated chronic lymphocytic leukaemia.

“We are particularly encouraged by the magnitude of benefit observed across key efficacy measures compared to a current standard of care, and we look forward to discussing these results with health authorities.”

Venclexta/Venclyxto is jointly commercialized by AbbVie and Genentech, a subsidiary of Roche in the US. Outside of the US, the drug is commercialized by AbbVie.

AbbVie research and development executive vice president, and chief scientific officer Michael Severino said: “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.”

According to AbbVie, the findings from the MURANO trial also serve as the phase 3 confirmatory study asked by the US Food and Drug Administration (FDA) when Venclexta was given an accelerated approval in April 2016.

The company says that regulatory submissions of venclexta/venclyxto in combination with Rituxan to health authority are in progress.


Image: AbbVie Corporate Headquarters. Photo: courtesy of AbbVie Inc.