Positive phase III results for Venclexta/Venclyxto combination in acute myeloid leukaemia presented at EHA 2020

• Phase III VIALE-A study showed Venclexta/Venclyxto plus azacitidine helped people with the most common type of aggressive adult leukaemia live longer compared to azacitidine alone
• Data will be presented as a late-breaking abstract at the 25th European Hematology Association Virtual Congress
  
  

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%).