Roche and AbbVie's leukaemia combo smashes Phase 3 endpoint

Venclexta/Venclyxto (venetoclax), Roche and AbbVie’s oral B-cell lymphoma-2 (BCL-2) inhibitor, successfully met its primary endpoint in Phase 3 trials, providing prolonged, progression-free survival in chronic lymphocytic leukaemia (CLL) when administered with Rituxan (rituximab).

The drug combo gave greater results than bendamustine combined with Rituxan, while producing no new safety signals or increase in known toxicities in the 389-participant study. According to the two companies, the trial was unblinded due to the positive results, on the recommendation of an independent data monitoring committee, and doctors will continue to monitor the participants in order to gather longer-term data on the drug’s safety and efficacy.

The therapy was originally awarded breakthrough therapy designation by the FDA in January last year based on the promising results of a Phase 2b study. This led to accelerated approval from the US regulator in April.

"Chronic lymphocytic leukaemia is considered incurable and becomes harder to treat with each relapse," commented Sandra Horning, Roche’s Chief Medical Officer and Head of Global Product Development. "This is the first study to show that Venclexta/Venclyxto plus Mabthera/Rituxan can help people with this type of leukaemia live significantly longer without their disease worsening compared to a standard-of-care regimen. We will work with health authorities to bring this potential chemotherapy-free treatment option to the people who need it as quickly as possible."

Michael Severino, Executive Vice President, Research and Development, and Chief Scientific Officer at AbbVie also remarked: "AbbVie is committed to researching the full potential of Venclexta/Venclyxto both as monotherapy and combination therapy in patients with CLL and other hematologic malignancies. The analysis of the MURANO trial showed that Venclexta/Venclyxto in combination with Rituxan may offer another option for patients with R/R CLL, potentially providing them with a chemotherapy-free therapy. We are looking forward to working with regulatory authorities around the world to bring this additional treatment regimen to relapsed/refractory CLL patients."