On September 18, 2017 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that the phase III MURANO study, which evaluated Venclexta/Venclyxto (venetoclax) in combination with MabThera/Rituxan (rituximab) in people with relapsed or refractory chronic lymphocytic leukaemia (CLL), met its primary endpoint and showed a statistically significant improvement in the time people lived without their disease progressing (progression-free survival [PFS] as assessed by investigator) when treated with Venclexta/Venclyxto plus MabThera/Rituxan compared to bendamustine plus Mabthera/Rituxan (Press release, Hoffmann-La Roche, SEP 18, 2017, View Source [SID1234520551]). No new safety signals or increase in known toxicities of Venclexta/Venclyxto were observed with the treatment combination of Venclexta/Venclyxto plus Mabthera/Rituxan. Venclexta/Venclyxto (venetoclax) is being developed by AbbVie and Roche. It is jointly commercialised by AbbVie and Genentech, a member of the Roche Group, in the United States and commercialised by AbbVie outside of the United States.
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"Chronic lymphocytic leukaemia is considered incurable and becomes harder to treat with each relapse," said Sandra Horning, MD, 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."
In January 2016, Roche announced that the US Food and Drug Administration (FDA) granted breakthrough therapy designation for Venclexta/Venclyxto in combination with Mabthera/Rituxan for the treatment of relapsed or refractory CLL based on promising results from the phase Ib M13-365 study. Breakthrough therapy designation is intended to expedite the development and review of medicines with early evidence of potential clinical benefit in serious or life-threatening diseases and to help ensure that patients receive access to medicines as soon as possible.
Venclexta/Venclyxto was granted accelerated approval by the FDA in April 2016 for the treatment of people with CLL with 17p deletion, as detected by an FDA approved test, who have received at least one prior therapy. The MURANO study is part of the company’s commitment in the United States to convert the current accelerated approval of Venclexta/Venclyxto to a full approval. Data from the MURANO study will be presented at an upcoming medical meeting and submitted to global health authorities.
About the MURANO Study
MURANO (NCT02005471) is a phase III open-label, international, multicentre, randomized study evaluating the efficacy and safety of Venclexta/Venclyxto in combination with Mabthera/Rituxan compared with bendamustine in combination with Mabthera/Rituxan. All treatments were of fixed duration. 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/Venclyxto plus Mabthera/Rituxan (Arm A) or bendamustine plus Mabthera/Rituxan (Arm B). The primary endpoint of the study is investigator-assessed PFS. Secondary endpoints include PFS assessed by independent review committee (IRC), best overall response, complete response, duration of response, overall survival, event-free survival, time to next CLL treatment and minimal residual disease (MRD) status.
About Venclexta/Venclyxto
Venclexta/Venclyxto 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. Venclexta/Venclyxto is being developed by AbbVie and Roche. It is jointly commercialised by AbbVie and Genentech, a member of the Roche Group, in the United States and commercialised by AbbVie outside of the United States.
Together, the companies are committed to further research with Venclexta/Venclyxto, which is currently being evaluated in phase III clinical trials for the treatment of CLL, along with studies in several other types of cancers. In the United States, Venclexta has been granted four breakthrough therapy designations by the FDA: in combination with Rituxan for people with relapsed or refractory CLL; as a monotherapy for people with relapsed or refractory CLL with 17p deletion; in combination with hypomethylating agents (azacitidine or decitabine) for people with untreated acute myeloid leukemia (AML) ineligible for intensive chemotherapy; and in combination with low-dose cytarabine (LDAC) for people with untreated AML ineligible for intensive chemotherapy.
About Chronic Lymphocytic Leukaemia (CLL)
Chronic lymphocytic leukaemia (CLL) is the most common type of leukaemia in the Western world.1 CLL mainly affects men and the median age at diagnosis is about 70 years2. Worldwide, the incidence of all leukaemias is estimated to be over 350,0001 and CLL is estimated to affect around one-third of all people newly diagnosed with leukaemia.3