Therapy Detail

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Therapy Name Obinutuzumab + Venetoclax
Synonyms
Therapy Description

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Obinutuzumab Gazyva R7159|afutuzumab|GA101|GA-101|RO 5072759 CD20 Antibody 11 Gazyva (obinutuzumab) is a glycoengineered anti-CD20 antibody that binds to CD20 on B-cells, resulting in increased antibody-dependent cellular cytotoxicity and induction of apoptosis, and potentially leading to decreased growth of B-cell tumors (PMID: 20194898, PMID: 21220500). Gazyva (obinutuzumab) is FDA approved in combination with Ambochlorin (chlorambucil) for chronic lymphocytic leukemia and in combination with Treanda (bendamustine) or chemotherapy for follicular lymphoma (FDA.gov).
Venetoclax Venclexta ABT-199|RG7601|GDC-0199|ABT119 BCL2 inhibitor 18 Venclexta (venetoclax) is a BH3-mimetic that binds to and inhibits BCL2, resulting in increased tumor cell apoptosis (PMID: 26589495, PMID: 25048785). Venclexta (venetoclax) is FDA approved for use in patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), and in combination with chemotherapy in patients 75 years old or older with newly-diagnosed acute myeloid leukemia (FDA.gov).

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  • Simple literal full or partial string matches
  • Separate multiple filter terms with a spaces, order doesn't matter (a b c and c b a are equivalent )
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  • Use quotes to match a longer phrase which contains spaces "mtor c1483f"

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
Unknown unknown CLL/SLL not applicable Obinutuzumab + Venetoclax FDA approved Actionable In a Phase III trial that supported FDA approval (CLL14), treatment with the combination of Venclexta (venetoclax) and Gazyva (obinutuzumab) resulted in improved progression-free survival (PFS) compared to treatment with Gazyva (obinutuzumab) plus chlorambucil ((HR 0.35; 95% CI 0.23-0.53; P<0.0001) (J Clin Oncol 37, 2019 (suppl; abstr 7502; NCT02242942). detail... detail...

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Clinical Trial Phase Therapies Title Recruitment Status
NCT03406156 Phase III Bendamustine + Obinutuzumab Obinutuzumab + Venetoclax Bendamustine A Study in Previously Untreated Chronic Lymphocytic Leukemia (CLL) Subjects, Excluding Those With the 17p Deletion, to Evaluate Debulking Regimens Prior to Initiating Venetoclax Combination Therapy Active, not recruiting
NCT01685892 Phase I Obinutuzumab + Venetoclax A Study of Venetoclax (GDC-0199; ABT-199) in Combination With Obinutuzumab in Participants With Chronic Lymphocytic Leukemia Completed
NCT03113422 Phase II Obinutuzumab Obinutuzumab + Venetoclax Bendamustine + Obinutuzumab + Venetoclax Phase II Venetoclax, Obinutuzumab and Bendamustine in High Tumor Burden Follicular Lymphoma as Front Line Therapy (PrE0403) Recruiting
NCT04447768 Phase II Obinutuzumab + Venetoclax The Combination of Venetoclax and Obinutuzumab in People With Chronic Lymphocytic Leukemia (CLL) Not yet recruiting
NCT04285567 Phase III Obinutuzumab + Venetoclax Bendamustine + Rituximab Cyclophosphamide + Fludarabine + Rituximab A Study to Compare the Efficacy and Safety of a Combined Regimen of Venetoclax and Obinutuzumab Versus Fludarabine, Cyclophosphamide, and Rituximab (FCR)/ Bendamustine And Rituximab (BR) in FIT Patients With Previously Untreated Chronic Lymphocytic Leukemia (CLL) Without DEL (17P) or TP53 Mutation (CRISTALLO) Recruiting
NCT02242942 Phase III Chlorambucil + Obinutuzumab Obinutuzumab + Venetoclax A Study to Compare the Efficacy and Safety of Obinutuzumab + GDC-0199 Versus Obinutuzumab + Chlorambucil in Patients With Chronic Lymphocytic Leukemia Active, not recruiting


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