Half-Year 2022 Financial and Clinical Trials Update slide image

Half-Year 2022 Financial and Clinical Trials Update

Venclexta Novel small molecule Bcl-2 selective inhibitor - myelodysplastic syndromes Indication Relapsed or refractory myelodysplastic syndromes (MDS) Treatment-naive myelodysplastic syndromes (MDS) Newly diagnosed higher-risk myelodysplatic syndrome (MDS) Phase/study Phase lb Phase lb Phase III VERONA # of patients Design Primary endpoint Status CT Identifier Cohort 1: N=70 ARM A: Venclexta 400 mg ARM B: Venclexta 800 mg Cohort 2: ARM A: Venclexta plus azacitidine Study expansion: Venclexta or Venclexta plus azacitidine Safety, efficacy, Pharmacokinetics and Pharmacodynamics FPI Q1 2017 Recruitment completed Q1 2022 NCT02966782 N=129 Dose escalation cohort: Venclexta plus azacitidine dose escalation Safety expansion cohort " Safety, Pharmacokinetics, RPTD FPI Q1 2017 Data presented at ASH 2019, ASH 2020 and ASCO 201 BTD granted by FDA July 2021 Recruitment completed Q1 2022 NCT02942290 " " N=500 ARM A: Venclexta plus azacitidine ARM B: Placebo plus azacitidine Complete remission rate and overall survival ■ FPI Q4 2020 NCT04401748 Joint project with AbbVie, in collaboration with The Walter and Eliza Hall Institute Bcl-2-B-cell lymphoma 2; BTD=Breakthrough therapy designation; RPTD=Recommended phase II dose; ASH-American Society of Hematology 98 Roche Oncology
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