Therapy Detail

Therapy Name Ibrutinib + Venetoclax
Synonym
Therapy Description

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Ibrutinib Imbruvica PCI-32765 BTK inhibitor 20 EGFR Inhibitor (Pan) 42 HER2 Inhibitor 21 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 approved for mantle cell lymphoma and first line treatment of chronic lymphocytic leukemia (FDA.gov).
Venetoclax Venclexta ABT-199|RG7601|GDC-0199 BCL2 inhibitor 15 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).
Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
Unknown unknown chronic lymphocytic leukemia not applicable 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...
NOTCH1 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
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...
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
Unknown unknown follicular lymphoma not applicable Ibrutinib + Venetoclax Preclinical - Cell culture Actionable In a preclinical study, the combination of Imbruvica (ibrutinib) and Venclexta (venetoclax) resulted in a synergistic effect, demonstrating growth suppression in follicular lymphoma cell lines in culture (PMID: 28428442). 28428442
Unknown unknown diffuse large B-cell lymphoma not applicable Ibrutinib + Venetoclax Preclinical - Cell culture Actionable In a preclinical study, the combination of Imbruvica (ibrutinib) and Venclexta (venetoclax) resulted in a synergistic effect, demonstrating growth suppression in germinal center B-cell diffuse large B-cell lymphoma (DLBCL) cell lines in culture, increased apoptotic activity and inhibition of colony formation in activated B-cell (ABC) DLBCL cell lines, and complete tumor growth inhibition in ABC-DLBCL cell line xenograft models (PMID: 28428442). 28428442
Clinical Trial Phase Therapies Title Recruitment Status
NCT03513562 Phase II Ibrutinib + Venetoclax Venetoclax and Ibrutinib in Treating in Participants With Chronic Lymphocytic Leukemia and Ibrutinib Resistance Mutations Recruiting
NCT02910583 Phase II Ibrutinib Ibrutinib + Venetoclax Ibrutinib Plus Venetoclax in Patients With Treatment-naive Chronic Lymphocytic Leukemia /Small Lymphocytic Lymphoma Active, not recruiting
NCT03943342 Phase II Ibrutinib Ibrutinib + Venetoclax Ibrutinib and Venetoclax in Treating Patients With Chronic Lymphocytic Leukemia After Ibrutinib Resistance Not yet recruiting
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) Recruiting
NCT02419560 Phase I Ibrutinib + Venetoclax Optimal Dose Finding Study ABT-199 and Ibrutinib in MCL Recruiting
NCT03112174 Phase III Ibrutinib Ibrutinib + Venetoclax Study of Ibrutinib Combined With Venetoclax in Subjects With Mantle Cell Lymphoma (SYMPATICO) Recruiting
NCT03873493 Phase II Ibrutinib + Venetoclax A Study Evaluating the Efficacy of Venetoclax Plus Ibrutinib in Subjects With T-cell Prolymphocytic Leukemia Not yet recruiting
NCT02756897 Phase II Ibrutinib + Venetoclax Venetoclax and Ibrutinib in Patients With Chronic Lymphocytic Leukemia (CLL) Active, not recruiting
NCT02956382 Phase Ib/II Ibrutinib + Venetoclax Ibrutinib and Venetoclax in Relapsed and Refractory Follicular Lymphoma Recruiting
NCT03045328 Phase Ib/II Ibrutinib + Venetoclax Venetoclax and Ibrutinib in Patients With Relapsed/Refractory CLL or SLL Recruiting
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 Recruiting