Therapy Detail

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Therapy Name Ibrutinib + Venetoclax
Synonyms
Therapy Description

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Ibrutinib Imbruvica PCI-32765 BTK inhibitor 26 EGFR Inhibitor (Pan) 50 HER2 Inhibitor 29 Imbruvica (ibrutinib) is a selective, irreversible inhibitor of Bruton's tyrosine kinase (BTK), which promotes apoptosis and inhibits B-cell mediated signaling pathways, and has additional activity against ERBB2 (HER2) and EGFR (PMID: 20615965, PMID: 21422473, PMID: 27678331). Imbruvica (Ibrutinib) is FDA approved for use in patients with mantle cell lymphoma, CLL/SLL and CLL/SLL with del 17p, Waldenstroem’s macroglobulinemia, marginal zone lymphoma, and in combination with Rituxan (rituximab) for untreated CLL/SLL (FDA.gov).
Venetoclax Venclexta ABT-199|RG7601|GDC-0199|ABT119 BCL2 inhibitor 20 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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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
ATM mutant mantle cell lymphoma predicted - sensitive Ibrutinib + Venetoclax Phase II Actionable In a Phase II trial (AIM), distinct molecular profiles were identified in mantle cell lymphoma patients responded to Imbruvica (ibrutinib) and Venclexta (venetoclax) combination therapy compared to those did not respond, with all patients harboring mutations in NSD2 (n=4), UBR5 (n=3), KMT2D (n=3), and 12 of 13 patients harboring mutations in ATM responded to the therapy, while SMARCA4 (n=4), CCND1 (n=2), and NOTCH1 (n=3) alterations were exclusively observed in nonresponders (PMID: 30455436; NCT02471391). 30455436
TP53 mutant chronic lymphocytic leukemia predicted - sensitive Ibrutinib + Venetoclax Phase II Actionable In a Phase II trial, Imbruvica (ibrutinib) and Venclexta (venetoclax) combination therapy resulted in a response rate of 100% (14/14, 9 complete response, 5 partial response) in relapsed or refractory chronic lymphocytic leukemia (CLL) patients, and a response rate of 100% (16/16, 9 complete response, 7 partial response) in untreated patients with high-risk features including del 17p, TP53 mutations, and del 11q (ASH, 59th Annual Meeting and Exposition, Dec 2017, Abstract 429; NCT02756897). detail...
SMARCA4 mutant mantle cell lymphoma predicted - resistant Ibrutinib + Venetoclax Phase II Actionable In a Phase II trial (AIM), distinct molecular profiles were identified in mantle cell lymphoma patients responded to Imbruvica (ibrutinib) and Venclexta (venetoclax) combination therapy compared to those did not respond, with all patients harboring mutations in NSD2 (n=4), UBR5 (n=3), KMT2D (n=3), and 12 of 13 patients harboring mutations in ATM responded to the therapy, while SMARCA4 (n=4), CCND1 (n=2), and NOTCH1 (n=3) alterations were exclusively observed in nonresponders (PMID: 30455436; NCT02471391). 30455436

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT03462719 Phase III Chlorambucil + Obinutuzumab Ibrutinib + Venetoclax A Study of the Combination of Ibrutinib Plus Venetoclax Versus Chlorambucil Plus Obinutuzumab for the First-line Treatment of Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) Active, not recruiting USA | CAN 12
NCT03422393 Phase I Ibrutinib + Venetoclax Venetoclax Venetoclax With High-dose Ibrutinib for the Treatment of Patients With Chronic Lymphocytic Leukemia With Progressive Disease on Single Agent Ibrutinib Active, not recruiting USA 0
NCT02419560 Phase I Ibrutinib + Venetoclax Optimal Dose Finding Study ABT-199 and Ibrutinib in MCL Active, not recruiting USA 0
NCT04802590 Phase II Ibrutinib Ibrutinib + Venetoclax Study of Ibrutinib + CD20 Antibody and Venetoclax in Patients With Untreated Mantle Cell Lymphoma Not yet recruiting 2
NCT02956382 Phase Ib/II Ibrutinib + Venetoclax Ibrutinib and Venetoclax in Relapsed and Refractory Follicular Lymphoma Recruiting USA 0
NCT03513562 Phase II Ibrutinib + Venetoclax Venetoclax and Ibrutinib in Treating in Participants With Chronic Lymphocytic Leukemia and Ibrutinib Resistance Mutations Recruiting USA 0
NCT03873493 Phase II Ibrutinib + Venetoclax A Study Evaluating the Efficacy of Venetoclax Plus Ibrutinib in Subjects With T-cell Prolymphocytic Leukemia Completed USA 8
NCT04273139 Phase II Ibrutinib + Venetoclax Ibrutinib + Venetoclax in Untreated WM Recruiting USA 0
NCT04010968 Phase II Ibrutinib + Venetoclax Cyclophosphamide + Fludarabine + Rituximab Evaluation of Risk-Adapted and MRD-Driven Strategy for Untreated Fit Patients With Intermediate Risk Chronic Lymphocytic Leukemia (ERADIC) Active, not recruiting 1
NCT04608318 Phase III Ibrutinib Ibrutinib + Venetoclax Obinutuzumab + Venetoclax Ibrutinib Monotherapy Versus Fixed-duration Venetoclax Plus Obinutuzumab Versus Fixed-duration Ibrutinib Plus Venetoclax in Patients With Previously Untreated Chronic Lymphocytic Leukaemia (CLL) (CLL17) Recruiting 1
NCT02756897 Phase II Ibrutinib + Venetoclax Venetoclax and Ibrutinib in Patients With Chronic Lymphocytic Leukemia (CLL) Active, not recruiting USA 0
NCT03045328 Phase Ib/II Ibrutinib + Venetoclax Venetoclax and Ibrutinib in Patients With Relapsed/Refractory CLL or SLL Completed USA 0
NCT03128879 Phase II Ibrutinib + Venetoclax Venetoclax and Ibrutinib in Treating Participants With High-Risk Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Recruiting USA 0
NCT03943342 Phase II Ibrutinib Ibrutinib + Venetoclax Ibrutinib and Venetoclax in Treating Patients With Chronic Lymphocytic Leukemia After Ibrutinib Resistance Withdrawn 0
NCT03112174 Phase III Ibrutinib Ibrutinib + Venetoclax Study of Ibrutinib Combined With Venetoclax in Subjects With Mantle Cell Lymphoma (SYMPATICO) Active, not recruiting USA | CAN 15
NCT02910583 Phase II Ibrutinib Ibrutinib + Venetoclax Ibrutinib Plus Venetoclax in Patients With Treatment-naive Chronic Lymphocytic Leukemia /Small Lymphocytic Lymphoma Active, not recruiting USA 4


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