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 35 EGFR Inhibitor (Pan) 59 HER2 Inhibitor 40 | 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|Venclyxto | BCL2 inhibitor 26 | 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... |
| BTK C481S | diffuse large B-cell lymphoma | sensitive | Ibrutinib + Venetoclax | Preclinical - Cell culture | Actionable | In a preclinical study, a diffuse large B-cell lymphoma cell line expressing BTK C481S resulting in Imbruvica (ibrutinib) resistance demonstrated increased sensitivity to Imbruvica (ibrutinib) when also treated with Venclexta (venetoclax), demonstrating decreased cell growth in culture (PMID: 28428442). | 28428442 |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| 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 |
| NCT04802590 | Phase II | Ibrutinib Ibrutinib + Venetoclax | Study of Ibrutinib + CD20 Antibody and Venetoclax in Patients With Untreated Mantle Cell Lymphoma | Recruiting | GBR | FRA | BEL | 0 |
| 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 |
| NCT03128879 | Phase II | Acalabrutinib + Venetoclax Ibrutinib + Venetoclax | Venetoclax With Ibrutinib or Acalabrutinib in Pts. With High-risk CLL | Recruiting | USA | 0 |
| NCT04273139 | Phase II | Ibrutinib + Venetoclax | Ibrutinib + Venetoclax in Untreated WM | Active, not recruiting | USA | 0 |
| NCT03112174 | Phase III | Ibrutinib Ibrutinib + Venetoclax | Study of Ibrutinib Combined With Venetoclax in Subjects With Mantle Cell Lymphoma (SYMPATICO) | Active, not recruiting | USA | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUS | 8 |
| NCT03513562 | Phase II | Ibrutinib + Venetoclax | Venetoclax and Ibrutinib in Treating in Participants With Chronic Lymphocytic Leukemia and Ibrutinib Resistance Mutations | Active, not recruiting | USA | 0 |
| NCT02419560 | Phase I | Ibrutinib + Venetoclax | Optimal Dose Finding Study ABT-199 and Ibrutinib in MCL | Completed | USA | 0 |
| NCT03943342 | Phase II | Ibrutinib Ibrutinib + Venetoclax | Ibrutinib and Venetoclax in Treating Patients With Chronic Lymphocytic Leukemia After Ibrutinib Resistance | Withdrawn | 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 | FRA | 0 |
| NCT02956382 | Phase Ib/II | Ibrutinib + Venetoclax | Ibrutinib and Venetoclax in Relapsed and Refractory Follicular Lymphoma | Active, not recruiting | USA | 0 |
| NCT02910583 | Phase II | Ibrutinib Ibrutinib + Venetoclax | Ibrutinib Plus Venetoclax in Patients With Treatment-naive Chronic Lymphocytic Leukemia /Small Lymphocytic Lymphoma | Active, not recruiting | USA | ITA | ESP | AUS | 2 |
| 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) | Active, not recruiting | ITA | ESP | DEU | BEL | AUT | 8 |
| NCT03873493 | Phase II | Ibrutinib + Venetoclax | A Study Evaluating the Efficacy of Venetoclax Plus Ibrutinib in Subjects With T-cell Prolymphocytic Leukemia | Completed | USA | ITA | GBR | FRA | DEU | AUT | AUS | 2 |
| 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) (GLOW) | Active, not recruiting | USA | GBR | FRA | ESP | CAN | BEL | 8 |
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