Therapy Detail
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| Therapy Name | Tirabrutinib |
| Synonyms | |
| Therapy Description |
Tirabrutinib (ONO-4059) is a selective inhibitor of BTK, which potentially induces antibody-dependent cell-mediated cytotoxicity against tumor cells and inhibits tumor growth (PMID: 27684575, PMID: 27776353, PMID: 32583848). |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Tirabrutinib | ONO-GS-4059|ONO-WG-307|ONO-4059|GS 4059|GS4059 | BTK inhibitor 39 | Tirabrutinib (ONO-4059) is a selective inhibitor of BTK, which potentially induces antibody-dependent cell-mediated cytotoxicity against tumor cells and inhibits tumor growth (PMID: 27684575, PMID: 27776353, PMID: 32583848). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|---|---|---|---|---|---|---|
| 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 |
| 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 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 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 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 |
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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 | Terminated | USA | GBR | FRA | 0 |
| NCT04947319 | Phase II | Tirabrutinib | Study of Tirabrutinib (ONO-4059) in Patients With Primary Central Nervous System Lymphoma (PROSPECT Study) | Active, not recruiting | USA | 0 |
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