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Therapy Name Tirabrutinib
Synonyms
Therapy Description

Tirabrutinib (ONO-4059) inhibits Bruton's Tyrosine Kinase (BTK), which leads to decreased B-cell proliferation and differentiation, and may have antitumor activity in B-cell malignancies (PMID: 23958373, PMID: 27776353, PMID: 32156743).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Tirabrutinib ONO-GS-4059|ONO-WG-307|ONO-4059 BTK inhibitor 36 Tirabrutinib (ONO-4059) inhibits Bruton's Tyrosine Kinase (BTK), which leads to decreased B-cell proliferation and differentiation, and may have antitumor activity in B-cell malignancies (PMID: 23958373, PMID: 27776353, PMID: 32156743).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
BTK T474I BTK C481S chronic lymphocytic leukemia predicted - resistant Tirabrutinib Case Reports/Case Series Actionable In Phase I trials, a patient with chronic lymphocytic leukemia progressed on treatment with Tirabrutinib (ONO-4059) and was subsequently found to have acquired BTK C481S and T474I (PMID: 37257190, NCT01659255 and NCT02457598). 37257190
BTK L528W chronic lymphocytic leukemia predicted - resistant Tirabrutinib Case Reports/Case Series Actionable In Phase I trials, two patients with chronic lymphocytic leukemia progressed on treatment with Tirabrutinib (ONO-4059) and each were subsequently found to have acquired BTK L528W (PMID: 37257190; NCT01659255 and NCT02457598). 37257190
BTK E108K BTK T474I BTK C481S BTK L528W chronic lymphocytic leukemia predicted - resistant Tirabrutinib Case Reports/Case Series Actionable In Phase I trials, a patient with chronic lymphocytic leukemia progressed on treatment with Tirabrutinib (ONO-4059) and was subsequently found to have acquired BTK C481S, T474I, L528W, and E108K (PMID: 37257190; NCT01659255 and NCT02457598). 37257190
BTK C481F diffuse large B-cell lymphoma resistant Tirabrutinib Preclinical - Cell culture Actionable In a preclinical study, diffuse large B-cell lymphoma cells that acquired resistance to Imbruvica (ibrutinib) harbored the BTK C481F mutation, and was resistant to Tirabrutinib (ONO-4059) in culture (PMID: 28178345). 28178345
BTK C481S chronic lymphocytic leukemia predicted - resistant Tirabrutinib Case Reports/Case Series Actionable In Phase I trials, a patient with chronic lymphocytic leukemia progressed on treatment with Tirabrutinib (ONO-4059) and was subsequently found to have acquired BTK C481S (PMID: 37257190; NCT01659255 and NCT02457598). 37257190
BTK T474I BTK C481S BTK L528W chronic lymphocytic leukemia predicted - resistant Tirabrutinib Case Reports/Case Series Actionable In Phase I trials, a patient with chronic lymphocytic leukemia progressed on treatment with Tirabrutinib (ONO-4059) and was subsequently found to have acquired BTK C481S, L528W, and T474I (PMID: 37257190;NCT01659255 and NCT02457598). 37257190

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT02457598 Phase I Entospletinib + Tirabrutinib Tirabrutinib Idelalisib + Obinutuzumab + Tirabrutinib Entospletinib + Obinutuzumab + Tirabrutinib Idelalisib + Tirabrutinib Dose Escalation and Dose Expansion Study of Tirabrutinib in Combination With Other Targeted Anti-cancer Therapies in Adults With B-cell Malignancies Active, not recruiting USA | GBR | FRA 0
NCT04947319 Phase II Tirabrutinib Study of Tirabrutinib (ONO-4059) in Patients With Primary Central Nervous System Lymphoma (PROSPECT Study) Recruiting USA 0


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