Therapy Detail
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| Therapy Name | Zanubrutinib |
| Synonyms | |
| Therapy Description |
Brukinsa (zanubrutinib) inhibits Bruton tyrosine kinase (BTK), leading to decreased B-cell activation and reduced growth of BTK over-expressing cells (PMID: 31378456). Brukinsa (zanubrutinib) is FDA approved for use in patients with mantle cell lymphoma, Waldenstrom’s macroglobulinemia, and chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) (FDA.gov). |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Zanubrutinib | Brukinsa | BGB-3111 | BTK inhibitor 37 | Brukinsa (zanubrutinib) inhibits Bruton tyrosine kinase (BTK), leading to decreased B-cell activation and reduced growth of BTK over-expressing cells (PMID: 31378456). Brukinsa (zanubrutinib) is FDA approved for use in patients with mantle cell lymphoma, Waldenstrom’s macroglobulinemia, and chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) (FDA.gov). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|---|---|---|---|---|---|---|
| TP53 mutant | chronic lymphocytic leukemia | sensitive | Zanubrutinib | Guideline | Actionable | Brukinsa (zanubrutinib) is included in guidelines as preferred first-line therapy for patients with advanced chronic lymphocytic leukemia harboring TP53 mutations and for patients with relapsed or refractory disease (PMID: 38969011; ESMO.org). | detail... 38969011 |
| TP53 loss | chronic lymphocytic leukemia/small lymphocytic lymphoma | sensitive | Zanubrutinib | Guideline | Actionable | Brukinsa (zanubrutinib) is included in guidelines as first line therapy and second line therapy and subsequent therapy for chronic lymphocytic leukemia/small lymphocytic lymphoma patients with TP53 loss (NCCN.org). | detail... |
| TP53 mutant | chronic lymphocytic leukemia/small lymphocytic lymphoma | predicted - sensitive | Zanubrutinib | Guideline | Actionable | Brukinsa (zanubrutinib) is included in guidelines as first line therapy and second line therapy and subsequent therapy for chronic lymphocytic leukemia/small lymphocytic lymphoma patients with a TP53 mutation (NCCN.org). | detail... |
| TP53 mutant | chronic lymphocytic leukemia/small lymphocytic lymphoma | predicted - sensitive | Zanubrutinib | Phase I | Actionable | In a Phase I trial, Brukinsa (zanubrutinib) treatment resulted in an overall response rate of 100% (16/16) in patients with CLL/SLL harboring del (17p) or TP53 mutations (PMID: 31340982; NCT02343120). | 31340982 |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT03846427 | Phase II | Zanubrutinib | Study of Zanubrutinib (BGB-3111) in Patients With Marginal Zone Lymphoma | Completed | USA | NZL | ITA | GBR | FRA | CZE | AUS | 2 |
| NCT06651970 | FDA approved | Obinutuzumab Zanubrutinib Rituximab Acalabrutinib Venetoclax | Acalabrutinib Monotherapy vs Investigator's Choice of Treatment in Patients With CL Leukaemia and Heart Failure | Not yet recruiting | USA | POL | ITA | GBR | ESP | CZE | 0 |
| NCT03053440 | Phase III | Ibrutinib Zanubrutinib | A Study Comparing BGB-3111 and Ibrutinib in Subjects With Waldenström's Macroglobulinemia (WM) | Completed | USA | SWE | POL | NLD | ITA | GRC | GBR | FRA | ESP | DEU | CZE | AUS | 0 |
| NCT04662255 | Phase III | Ibrutinib Zanubrutinib Pirtobrutinib Acalabrutinib | Study of BTK Inhibitor LOXO-305 Versus Approved BTK Inhibitor Drugs in Patients With Mantle Cell Lymphoma (MCL) (BRUIN-MCL-321) | Active, not recruiting | USA | POL | NZL | NLD | ITA | ISR | IRL | HUN | GBR | FRA | ESP | DNK | DEU | CZE | CHE | CAN | BRA | BEL | AUT | AUS | 6 |
| NCT03336333 | Phase III | Venetoclax + Zanubrutinib Zanubrutinib Bendamustine + Rituximab | A Study Comparing Zanubrutinib With Bendamustine Plus Rituximab in Participants With Previously Untreated CLL or SLL (SEQUOIA) | Active, not recruiting | USA | SWE | POL | NZL | ITA | GBR | FRA | ESP | CZE | BEL | AUT | AUS | 3 |
| NCT05202782 | Phase II | Zanubrutinib | Zanubrutinib and CAR T-cell Therapy for the Treatment of Recurrent or Refractory Aggressive B-cell Non-Hodgkin's Lymphoma or Transformed Indolent B-cell Lymphoma | Active, not recruiting | USA | 0 |
| NCT04170283 | Phase III | Zanubrutinib | Long-term Extension Study of Zanubrutinib (BGB-3111) in Patients With B-cell Malignancies | Enrolling by invitation | USA | TUR | SWE | POL | NZL | NLD | ITA | GRC | GBR | FRA | ESP | DEU | CZE | AUS | 2 |
| NCT02343120 | Phase I | Zanubrutinib | Study of the Safety and Pharmacokinetics of BGB-3111 in Subjects With B-Cell Lymphoid Malignancies | Completed | USA | NZL | ITA | GBR | AUS | 1 |
| NCT04116437 | Phase II | Zanubrutinib | A Study of Zanubrutinib (BGB-3111) in Patients With Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Intolerant of Prior Treatment With Ibrutinib | Recruiting | USA | 0 |
| NCT04052854 | Expanded access | Zanubrutinib | A Single-Arm, Expanded Access Study of Zanubrutinib (BGB3111) in Patients With B-cell Malignancies | No longer available | USA | 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 |
| NCT05976763 | Phase III | Zanubrutinib Rituximab + Zanubrutinib | Testing Continuous Versus Intermittent Treatment With the Study Drug Zanubrutinib for Older Patients With Previously Untreated Mantle Cell Lymphoma | Recruiting | USA | 0 |
| NCT03734016 | Phase III | Ibrutinib Zanubrutinib | A Study of Zanubrutinib (BGB-3111) Versus Ibrutinib in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia | Completed | USA | TUR | SWE | POL | NZL | NLD | ITA | GBR | FRA | ESP | DEU | CZE | BEL | AUS | 1 |
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