Therapy Detail

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Therapy Name Zanubrutinib
Synonyms
Therapy Description

Zanubrutinib (BGB-3111) inhibits Bruton Tyrosine Kinase (BTK), leading to decreased B-cell activation and reduced growth of BTK over-expressing B-cells (NCI Drug Dictionary).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Zanubrutinib Brukinsa BGB-3111 BTK inhibitor 32 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 and in patients with Waldenstrom’s macroglobulinemia(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/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...
BTK T474M BTK C481S Advanced Solid Tumor predicted - resistant Zanubrutinib Preclinical - Biochemical Actionable In a preclinical study, treatment with Brukinsa (zanubrutinib) failed to inhibit Btk activity in a cell line expressing BTK variants T474M and C481S in culture (PMID: 33526860). 33526860
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...
BTK T474I BTK C481S Advanced Solid Tumor predicted - resistant Zanubrutinib Preclinical - Biochemical Actionable In a preclinical study, treatment with Brukinsa (zanubrutinib) failed to inhibit Btk activity in a cell line expressing BTK variants T474I and C481S in culture (PMID: 33526860). 33526860
BTK C481S chronic lymphocytic leukemia/small lymphocytic lymphoma resistant Zanubrutinib Guideline Actionable Brukinsa (zanubrutinib) is not indicated for use in patients with Imbruvica (ibrutinib)-refractory chronic lymphocytic leukemia/small lymphocytic lymphoma harboring BTK C481S (NCCN.org). detail...

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT03053440 Phase III Ibrutinib Zanubrutinib A Study Comparing BGB-3111 and Ibrutinib in Subjects With Waldenström's Macroglobulinemia (WM) Completed USA | ITA | FRA | ESP | DEU | BEL 7
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
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 | FRA | ESP | BEL | AUT 8
NCT04170283 Phase III Zanubrutinib Long-term Extension Study of Zanubrutinib (BGB-3111) in Patients With B-cell Malignancies Enrolling by invitation USA | ITA | FRA | ESP | DEU 9
NCT03734016 Phase III Ibrutinib Zanubrutinib A Study of Zanubrutinib (BGB-3111) Versus Ibrutinib in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia Active, not recruiting USA | ITA | FRA | ESP | DEU | BEL 9
NCT03846427 Phase II Zanubrutinib Study of Zanubrutinib (BGB-3111) in Patients With Marginal Zone Lymphoma Completed USA | ITA | FRA 5
NCT02343120 Phase I Zanubrutinib Study of the Safety and Pharmacokinetics of BGB-3111 in Subjects With B-Cell Lymphoid Malignancies Completed USA | ITA 4
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
NCT04662255 Phase III Ibrutinib Zanubrutinib LOXO-305 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 | FRA | ESP | DEU | CAN | BEL | AUT 16
NCT04052854 Expanded access Zanubrutinib A Single-Arm, Expanded Access Study of Zanubrutinib (BGB3111) in Patients With B-cell Malignancies No longer available USA 0


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