Therapy Detail
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| Therapy Name | Birabresib |
| Synonyms | |
| Therapy Description |
Birabresib (OTX015) is an inhibitor of the BET bromodomain proteins BRD3, BRD4, and BRD5, which inhibits interaction with acetylated histone H4, potentially resulting in decreased tumor cell proliferation (Mol Cancer Ther Nov 2013 12:C244, PMID: 29733771). |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Birabresib | Y-803|MK-8628|OTX015 | BET Inhibitor (Pan) 27 | Birabresib (OTX015) is an inhibitor of the BET bromodomain proteins BRD3, BRD4, and BRD5, which inhibits interaction with acetylated histone H4, potentially resulting in decreased tumor cell proliferation (Mol Cancer Ther Nov 2013 12:C244, PMID: 29733771, PMID: 31204545). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|---|---|---|---|---|---|---|
| Unknown unknown | triple-receptor negative breast cancer | not applicable | Birabresib | Preclinical - Cell culture | Actionable | In a preclinical study, triple-receptor negative breast cancer cells demonstrated sensitivity to treatment with Birabresib (OTX015), resulting in decreased cell proliferation in culture (PMID: 27256375). | 27256375 |
| Unknown unknown | prostate cancer | not applicable | Birabresib | Preclinical - Cell line xenograft | Actionable | In a preclinical study, Birabresib (OTX015) treatment inhibited tumor growth in a cell line xenograft model of prostate cancer (PMID: 27274052). | 27274052 |
| Unknown unknown | diffuse large B-cell lymphoma | not applicable | Birabresib | Preclinical - Cell line xenograft | Actionable | In a preclinical study, Birabresib (OTX015) resulted in apoptotic activity and inhibition of Myc and downstream signaling pathways in diffuse large B-cell lymphoma cell lines in culture, and reduced tumor growth in xenograft models (PMID: 25623213). | 25623213 |
| Unknown unknown | NUT midline carcinoma | not applicable | Birabresib | Phase Ib/II | Actionable | In a Phase Ib trial, Birabresib (OTX015) demonstrated favorable safety and resulted in partial response in 33% (3/9) and stable disease in 33% (3/9) patients with NUT midline carcinoma (PMID: 29733771; NCT02259114). | 29733771 |
| Unknown unknown | NUT midline carcinoma | not applicable | Birabresib | Preclinical - Cell line xenograft | Actionable | In a preclinical study, Birabresib (OTX015) inhibited tumor growth in cell line xenograft models of NUT midline carcinoma (Mol Cancer Ther November 2013 12; C244). | detail... |
| Unknown unknown | acute myeloid leukemia | not applicable | Birabresib | Phase I | Actionable | In a Phase I trial, Birabresib (OTX015) treatment resulted in complete remission lasting 2-5 months in 8% (3/36) and partial blast clearance in 6% (2/36) of acute myeloid leukaemia patients (PMID: 27063977). | 27063977 |
| Unknown unknown | Advanced Solid Tumor | not applicable | Birabresib | Phase Ib/II | Actionable | In a Phase Ib trial, Birabresib (OTX015) demonstrated favorable safety and resulted in partial response in 7% (3/42) and stable disease in 60% (25/42) of patients with non-small cell lung cancer, prostate cancer, or NUT midline carcinoma, with all of the responses occurring in NUT midline carcinoma patients (PMID: 29733771; NCT02259114). | 29733771 |
| Unknown unknown | Advanced Solid Tumor | not applicable | Birabresib | Preclinical - Cell culture | Actionable | In a preclinical study, Birabresib (OTX015) inhibited growth of a variety of tumor cell lines in cell culture (Mol Cancer Ther November 2013 12; C244). | detail... |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status |
|---|---|---|---|---|
| NCT02698189 | Phase I | Birabresib | A Dose Exploration Study With MK-8628 in Participants With Selected Hematologic Malignancies (MK-8628-005) | Active, not recruiting |
| NCT02259114 | Phase I | Birabresib | A Phase IB Trial With OTX015, a Small Molecule Inhibitor of the Bromodomain and Extra-Terminal (BET) Proteins, in Patients With Selected Advanced Solid Tumors | Completed |
| NCT02698176 | Phase I | Birabresib | A Dose Exploration Study With MK-8628 in Participants With Selected Advanced Solid Tumors (MK-8628-006) | Terminated |
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