Roche has announced that data from the pivotal Phase III MURANO and CLL14 studies support the efficacy of fixed-duration, chemotherapy-free Venclexta/Venclyxto (venetoclax)-based combinations in some patients with chronic lymphocytic leukaemia (CLL).

Being developed by AbbVie and Roche, Venclexta/Venclyxto is a targeted medicine that can selectively attach and inhibit the B-cell lymphoma-2 (BCL-2) protein.

The open-label, international, multi-centre, randomised MURANO trial analysed the efficacy and safety of fixed-duration Venclexta/Venclyxto in combination with MabThera/Rituxan (rituximab) versus bendamustine plus MabThera/Rituxan (BR).

Sustained investigator-assessed progression-free survival (PFS) with Venclexta/Venclyxto plus MabThera/Rituxan was observed in the trial.

The combination reduced the risk of disease progression or death by 81% versus bendamustine plus MabThera/Rituxan (BR) in people with relapsed or refractory (R/R) CLL.

The five-year OS was 82.1% in the Venclexta/Venclyxto plus MabThera/Rituxan arm while it was 62.2% in the BR arm.

In the Venclexta/Venclyxto arm, of the 130 patients who completed two years of treatment without progressive disease, 63.8% also had undetectable minimal residual disease (uMRD) levels at the end of therapy.

The randomised CLL14 trial analysed the combination of fixed-duration Venclexta/Venclyxto plus Gazyva/Gazyvaro (obinutuzumab) versus Gazyva/Gazyvaro plus chlorambucil in adult patients with untreated CLL and co-existing medical conditions.

According to the data, longer PFS was observed in patients with uMRD and a partial response (PR) than those with detectable MRD and a complete response (CR).

In addition, the two trials showed that CLL patients treated with Venclexta/Venclyxto-based regimens had higher rates of undetectable minimal residual disease, which may be linked to lower risk of future disease progression or death.

Roche Global Product Development head and chief medical officer Levi Garraway said: “These results reinforce the long-term value of fixed-duration, chemotherapy-free Venclexta/Venclyxto-based combinations in CLL, potentially offering patients a significant period of time without treatment following initial therapy.

“These data also reflect our ongoing commitment to accelerating clinical advancements for patients by exploring the novel endpoint minimal residual disease as a potential predictor of patient outcomes.”