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 35 | 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 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 | 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 |
| 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... |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT03734016 | Phase III | Ibrutinib Zanubrutinib | A Study of Zanubrutinib (BGB-3111) Versus Ibrutinib in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia | Active, not recruiting | 1 | |
| NCT03053440 | Phase III | Ibrutinib Zanubrutinib | A Study Comparing BGB-3111 and Ibrutinib in Subjects With Waldenström's Macroglobulinemia (WM) | Completed | USA | ITA | GBR | FRA | ESP | DEU | BEL | AUS | 5 |
| NCT03846427 | Phase II | Zanubrutinib | Study of Zanubrutinib (BGB-3111) in Patients With Marginal Zone Lymphoma | Completed | USA | ITA | GBR | FRA | AUS | 4 |
| 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) | Recruiting | USA | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUT | AUS | 16 |
| NCT02343120 | Phase I | Zanubrutinib | Study of the Safety and Pharmacokinetics of BGB-3111 in Subjects With B-Cell Lymphoid Malignancies | Completed | USA | ITA | GBR | AUS | 2 |
| 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 |
| NCT04170283 | Phase III | Zanubrutinib | Long-term Extension Study of Zanubrutinib (BGB-3111) in Patients With B-cell Malignancies | Enrolling by invitation | USA | ITA | GBR | ESP | DEU | AUS | 7 |
| 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 | ITA | GBR | FRA | ESP | BEL | AUT | AUS | 7 |
| NCT04052854 | Expanded access | Zanubrutinib | A Single-Arm, Expanded Access Study of Zanubrutinib (BGB3111) in Patients With B-cell Malignancies | No longer available | USA | 0 |
| 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 | Recruiting | USA | 0 |
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