Basel, 13 June 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced positive results from the phase III VIALE-A study, evaluating Venclexta®/Venclyxto® (venetoclax) in combination with azacitidine in people with previously untreated acute myeloid leukaemia (AML) who were ineligible for intensive induction chemotherapy. VIALE-A results were featured in the 25th European Hematology Association Virtual Congress Press Briefing on Saturday 13 June 2020 at 08:30 CEST and will be presented at the congress during the Late-breaking Oral Session (abstract #LB2601) on Sunday 14 June 2020.
“We are very pleased to present these important results from people with acute myeloid leukaemia, especially those who are unable to tolerate intensive chemotherapy and therefore have limited treatment options,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “The significant survival benefits observed in the VIALE-A study reinforce the potential utility of this Venclexta/Venclyxto-based combination for people with this aggressive disease.”
Results from the VIALE-A study showed that the Venclexta/Venclyxto combination reduced the risk of death (overall survival [OS]) by 34% compared to azacitidine alone (median OS=14.7 months vs. 9.6 months; HR: 0.66, 95% CI: 0.52–0.85, p<0.001) in people with previously untreated AML. The Venclexta/Venclyxto plus azacitidine combination also led to higher rates of composite complete remission (CR + CR with incomplete blood count recovery [CR + CRi]) at 66.4% compared to 28.3% with azacitidine alone (p<0.001).
Safety for Venclexta/Venclyxto plus azacitidine appeared consistent with the known safety profile of these medicines and no unexpected safety signals were identified with the combination. Notable grade 3 or higher adverse events in the Venclexta/Venclyxto plus azacitidine and azacitidine alone arms included low platelet count (thrombocytopenia; 45% vs. 38%), low white blood cell count (neutropenia; 42% vs. 29%; leukopenia; 21% vs. 12%), low white blood cell count with fever (febrile neutropenia; 42% vs. 19%) and low red blood cell count (anaemia; 26% vs. 20%).
The study also met its secondary endpoint of CR and CR with partial haematologic recovery (CR + CRh), with the combination showing a CR + CRh of 64.7% compared to 22.8% with azacitidine alone.
Data from the VIALE-A study has been shared with health authorities globally including the US Food and Drug Administration (FDA). Venclexta has previously been granted accelerated approval by the FDA in combination with azacitidine, or decitabine, or low-dose cytarabine for the treatment of people with newly diagnosed AML who are aged 75 years or older, or for those ineligible for intensive induction chemotherapy due to coexisting medical conditions. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory studies. VIALE-A is part of Venclexta’s ongoing development programme to convert the current accelerated approval of Venclexta, granted by the FDA in previously untreated AML, to a full approval. Venclexta has also been granted five Breakthrough Therapy Designations by the FDA, including two for previously untreated AML.
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 US, and commercialised by AbbVie outside of the US.
About the VIALE-A study
VIALE-A (NCT02993523) is a phase III, randomised, double-blind, placebo-controlled multicenter study evaluating the efficacy and safety of Venclexta®/Venclyxto® (venetoclax) plus azacitidine, a hypomethylating agent, compared to placebo plus azacitidine, in 433 people with previously untreated acute myeloid leukaemia who are ineligible for intensive chemotherapy. Two-thirds of patients received 400 mg Venclexta/Venclyxto daily, in combination with azacitidine, and the remaining patients received placebo tablets in combination with azacitidine. Patients enrolled in the study had a range of mutational subtypes, including IDH1/2 and FLT3. The primary endpoints of the study are overall survival (OS) and rate of complete remission (CR) and CR with incomplete blood count recovery (CRi). OS was the sole primary endpoint in the United States (US) and US reference countries, and OS and CR + CRi were co-primary endpoints in China, Japan, the European Union (EU) and EU reference countries. Secondary endpoints include CR and CR with partial haematologic recovery (CRh), event-free survival, transfusion independence and patient-reported outcomes.