Therapy Detail

Contact

Missing content? – Request curation!

Request curation for specific Genes, Variants, or PubMed publications.

Have questions, comments, or suggestions? - Let us know!

Email us at : ckbsupport@genomenon.com

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).

Filtering

  • Case insensitive filtering will display rows if any text in any cell matches the filter term
  • Use simple literal full or partial string matches
  • Separate multiple filter terms with a space. Any order may be used (i. e. a b c and c b a are equivalent )
  • Filtering will only apply to rows that are already loaded on the page. Filtering has no impact on query parameters.
  • Use quotes to match on a longer phrase with spaces (i.e. "mtor c1483f")

Sorting

  • Generally, the default sort order for tables is set to be first column ascending; however, specific tables may set a different default sort order.
  • Click on any column header arrows to sort by that column
  • Hold down the Shift key and click multiple columns to sort by more than one column. Be sure to set ascending or descending order for a given column before moving on to the next column.

Drug Name Trade Name Synonyms Drug Classes Drug Description
Zanubrutinib Brukinsa BGB-3111 BTK inhibitor 38 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).

Filtering

  • Case insensitive filtering will display rows if any text in any cell matches the filter term
  • Use simple literal full or partial string matches
  • Separate multiple filter terms with a space. Any order may be used (i. e. a b c and c b a are equivalent )
  • Filtering will only apply to rows that are already loaded on the page. Filtering has no impact on query parameters.
  • Use quotes to match on a longer phrase with spaces (i.e. "mtor c1483f")

Sorting

  • Generally, the default sort order for tables is set to be first column ascending; however, specific tables may set a different default sort order.
  • Click on any column header arrows to sort by that column
  • Hold down the Shift key and click multiple columns to sort by more than one column. Be sure to set ascending or descending order for a given column before moving on to the next column.

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 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 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...

Filtering

  • Case insensitive filtering will display rows if any text in any cell matches the filter term
  • Use simple literal full or partial string matches
  • Separate multiple filter terms with a space. Any order may be used (i. e. a b c and c b a are equivalent )
  • Filtering will only apply to rows that are already loaded on the page. Filtering has no impact on query parameters.
  • Use quotes to match on a longer phrase with spaces (i.e. "mtor c1483f")

Sorting

  • Generally, the default sort order for tables is set to be first column ascending; however, specific tables may set a different default sort order.
  • Click on any column header arrows to sort by that column
  • Hold down the Shift key and click multiple columns to sort by more than one column. Be sure to set ascending or descending order for a given column before moving on to the next column.

Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
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
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 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 3
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
NCT03846427 Phase II Zanubrutinib Study of Zanubrutinib (BGB-3111) in Patients With Marginal Zone Lymphoma Completed USA | NZL | ITA | GBR | FRA | CZE | AUS 2
NCT04052854 Expanded access Zanubrutinib A Single-Arm, Expanded Access Study of Zanubrutinib (BGB3111) in Patients With B-cell Malignancies No longer available USA 0
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
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
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
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
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
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
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
NCT06637501 Phase II Zanubrutinib BGB-11417 + Zanubrutinib A Study to Investigate Sonrotoclax Combined With Zanubrutinib Versus Zanubrutinib Alone in Participants With Previously Untreated Chronic Lymphocytic Leukemia Recruiting USA | POL | ITA | ESP | BRA 1


Additional content available in CKB BOOST