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 37 EGFR Inhibitor (Pan) 62 HER2 Inhibitor 42 | 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 27 | 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 |
|---|---|---|---|---|---|---|---|
| TP53 loss | chronic lymphocytic leukemia/small lymphocytic lymphoma | sensitive | Ibrutinib + Venetoclax | Guideline | Actionable | Venclexta (venetoclax) combined with Imbruvica (ibrutinib) is indicated in guidelines as first-line (category 2A), second-line, or third-line therapy (category 2B) for chronic lymphocytic leukemia/small lymphocytic lymphoma patients with TP53 loss (NCCN.org). | detail... |
| TP53 mutant | chronic lymphocytic leukemia/small lymphocytic lymphoma | sensitive | Ibrutinib + Venetoclax | Guideline | Actionable | Venclexta (venetoclax) combined with Imbruvica (ibrutinib) is indicated in guidelines as first-line (category 2A), second-line, or third-line therapy (category 2B) for chronic lymphocytic leukemia/small lymphocytic lymphoma patients with a TP53 mutation (NCCN.org). | 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 |
| 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 |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT03873493 | Phase II | Ibrutinib + Venetoclax | A Study Evaluating the Efficacy of Venetoclax Plus Ibrutinib in Subjects With T-cell Prolymphocytic Leukemia | Completed | USA | NLD | ITA | GBR | FRA | FIN | DEU | AUT | AUS | 0 |
| NCT06520098 | Phase II | Ibrutinib Zanubrutinib Ibrutinib + Venetoclax Venetoclax + Zanubrutinib Acalabrutinib Acalabrutinib + Venetoclax | A Randomized Phase II Study Of Bruton Tyrosine Kinase Inhibitor With Or Without Venetoclax In Veterans With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) (Benefit VA) | Not yet recruiting | USA | 0 |
| NCT03045328 | Phase Ib/II | Ibrutinib + Venetoclax | Venetoclax and Ibrutinib in Patients With Relapsed/Refractory CLL or SLL | Completed | USA | 0 |
| 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 |
| NCT02910583 | Phase II | Ibrutinib Ibrutinib + Venetoclax | Ibrutinib Plus Venetoclax in Patients With Treatment-naive Chronic Lymphocytic Leukemia /Small Lymphocytic Lymphoma | Completed | USA | POL | NZL | ITA | ESP | AUS | 0 |
| 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 | SWE | NOR | NLD | ITA | ISR | IRL | FIN | ESP | DNK | DEU | CHE | BEL | AUT | 0 |
| NCT04273139 | Phase II | Ibrutinib + Venetoclax | Ibrutinib + Venetoclax in Untreated WM | Active, not recruiting | USA | 0 |
| NCT02756897 | Phase II | Ibrutinib + Venetoclax | Venetoclax and Ibrutinib in Patients With Chronic Lymphocytic Leukemia (CLL) | Active, not recruiting | USA | 0 |
| NCT05963074 | Phase II | Ibrutinib Ibrutinib + Venetoclax | A Study to Customize Ibrutinib Treatment Regimens for Participants With Previously Untreated Chronic Lymphocytic Leukemia (TAILOR) | Recruiting | USA | POL | ITA | HUN | FRA | ESP | CZE | CAN | 0 |
| NCT03128879 | Phase II | Acalabrutinib + Venetoclax Ibrutinib + Venetoclax | Venetoclax With Ibrutinib or Acalabrutinib in Pts. With High-risk CLL | 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 | FRA | 0 |
| NCT03943342 | Phase II | Ibrutinib Ibrutinib + Venetoclax | Ibrutinib and Venetoclax in Treating Patients With Chronic Lymphocytic Leukemia After Ibrutinib Resistance | Withdrawn | 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 |
| NCT02956382 | Phase Ib/II | Ibrutinib + Venetoclax | Ibrutinib and Venetoclax in Relapsed and Refractory Follicular Lymphoma | Active, not recruiting | USA | 0 |
| 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 | TUR | SWE | POL | NLD | ISR | GBR | FRA | ESP | DNK | CZE | CAN | BEL | 1 |
| NCT03112174 | Phase III | Ibrutinib Ibrutinib + Venetoclax | Study of Ibrutinib Combined With Venetoclax in Subjects With Mantle Cell Lymphoma (SYMPATICO) | Completed | USA | TUR | POL | NLD | ITA | HUN | GRC | GBR | FRA | ESP | DEU | CZE | CAN | BEL | AUS | 2 |
| 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 | Completed | USA | 0 |
| NCT06524375 | Phase II | Acalabrutinib + Venetoclax Ibrutinib + Venetoclax Venetoclax + Zanubrutinib | A Study to Evaluate the Effect of Venetoclax on Participants Receiving a Covalent Bruton's Tyrosine Kinase Inhibitor (cBTKi) for First-Line Chronic Lymphocytic Leukemia (1L CLL) to Achieve Deep Durable Remissions to Allow Off-Treatment Period (BRAVE) | Recruiting | USA | 0 |
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