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|OTX-015 BET Inhibitor (Pan) 30 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 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
FBXW7 W425R adult T-cell leukemia resistant Birabresib Preclinical - Cell culture Actionable In a preclinical study, adult T cell leukemia cells expressing FBXW7 W425R demonstrated resistance to treatment with Birabresib (OTX015) in culture (PMID: 32907612). 32907612
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...
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 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 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 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
FBXW7 S462P adult T-cell leukemia resistant Birabresib Preclinical - Cell culture Actionable In a preclinical study, adult T cell leukemia cells expressing FBXW7 S462P were resistant to treatment with Birabresib (OTX015) in culture (PMID: 32907612). 32907612
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 adult T-cell leukemia not applicable Birabresib Preclinical - Patient cell culture Actionable In a preclinical study, patient-derived adult T cell leukemia cell lines with likely activation of Myc pathway signaling demonstrated decreased proliferation when treated with Birabresib (OTX015) in culture (PMID: 32907612). 32907612
FBXW7 H468R adult T-cell leukemia resistant Birabresib Preclinical - Cell culture Actionable In a preclinical study, adult T cell leukemia cells expressing FBXW7 H468R were resistant to treatment with Birabresib (OTX015) in culture (PMID: 32907612). 32907612
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

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT02698189 Phase I Birabresib A Dose Exploration Study With MK-8628 in Participants With Selected Hematologic Malignancies (MK-8628-005) Active, not recruiting 0
NCT02698176 Phase I Birabresib A Dose Exploration Study With MK-8628 in Participants With Selected Advanced Solid Tumors (MK-8628-006) Terminated 0
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 0


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