19 September 2017 - - South San Francisco, California-based biotechnology company Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), has provided positive results from the Phase III MURANO study, which evaluated Venclexta (venetoclax) in combination with Rituxan (rituximab) in people with relapsed or refractory chronic lymphocytic leukaemia (CLL), the company said.
The study met its primary endpoint and showed a statistically significant improvement in progression-free survival (PFS) as assessed by investigator when treated with Venclexta plus Rituxan compared to bendamustine plus Rituxan.
No new safety signals or increase in known toxicities of Venclexta were observed with the treatment combination of Venclexta plus Rituxan.
Venclexta is being developed by AbbVie and Genentech, a member of the Roche Group. It is jointly commercialized by the companies in the United States and commercialized by AbbVie outside of the United States.
The US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for Venclexta in combination with Rituxan for the treatment of relapsed or refractory CLL based on promising results from the Phase Ib M13-365 study.
The MURANO study, a Phase III open-label, international, multicenter, randomized study, is part of the company's commitment in the United States to convert the current accelerated approval of Venclexta to a full approval.
The study included 389 patients with relapsed or refractory CLL who had been previously treated with at least one but not more than three lines of therapy. Patients were randomly assigned in a 1:1 ratio to receive either Venclexta plus Rituxan (Arm A) or bendamustine plus Rituxan (Arm B).
Venclexta is a small molecule designed to selectively bind and inhibit the BCL-2 protein, which plays an important role in a process called apoptosis (programmed cell death). Overexpression of the BCL-2 protein in CLL has been associated with resistance to certain therapies. It is believed that blocking BCL-2 may restore the signaling system that tells cells, including cancer cells, to self-destruct.
For more than 20 years, Genentech has been developing medicines with the goal to redefine treatment in hematology.
In addition to approved medicines, Genentech's pipeline of investigational hematology medicines includes an anti-CD79b antibody drug conjugate (polatuzumab vedotin/RG7596) and a small molecule antagonist of MDM2 (idasanutlin/RG7388).
Genentech's dedication to developing novel medicines for blood diseases expands beyond oncology, with the development of the investigational hemophilia A treatment emicizumab.