Therapy Detail

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Therapy Name Brentuximab vedotin
Synonyms
Therapy Description

Adcetris (brentuximab vedotin) is an antibody-drug conjugate comprised of a monoclonal antibody targeting CD30 linked to the tubulin-binding drug MMAE, which binds CD30-expressing cells and disrupts microtubule polymerization, potentially resulting in decreased tumor growth (PMID: 22684302). Adcetris (brentuximab vedotin) is FDA approved for Hodgkin lymphoma, anaplastic large cell lymphoma, CD30-expressing mycosis fungoides, and in combination with chemotherapy in other CD30-expressing peripheral T-cell lymphomas (FDA.gov).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Brentuximab vedotin Adcetris SGN-35 Adcetris (brentuximab vedotin) is an antibody-drug conjugate comprised of a monoclonal antibody targeting CD30 linked to the tubulin-binding drug MMAE, which binds CD30-expressing cells and disrupts microtubule polymerization, potentially resulting in decreased tumor growth (PMID: 22684302). Adcetris (brentuximab vedotin) is FDA approved for Hodgkin lymphoma, anaplastic large cell lymphoma, CD30-expressing mycosis fungoides, and in combination with chemotherapy in other CD30-expressing peripheral T-cell lymphomas (FDA.gov).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
ALK negative anaplastic large cell lymphoma predicted - sensitive Brentuximab vedotin Phase II Actionable In a Phase II trial (SGN-35), Adcetris (brentuximab vedotin) treatment resulted in complete remission in 57% (33/58), partial remission in 29% (17/58) of patients with relapsed or refractory systemic anaplastic large cell lymphoma, 72% (42/58) of the patients were ALK-negative (PMID: 22614995; NCT00866047). 22614995
Unknown unknown Hodgkin's lymphoma not applicable Brentuximab vedotin FDA approved Actionable In a Phase III trial (AETHERA) that supported FDA approval, Adcetris (brentuximab vedotin) treatment as consolidation therapy after autologous stem-cell transplantation resulted in significantly improved progression-free survival compared to placebo (42.9 vs 24.1 months, HR=0.57, p=0.0013) in patients with classical Hodgkin's lymphoma at risk for relapse or progression after transplantation (PMID: 25796459; NCT01100502). detail... 25796459
Unknown unknown Hodgkin's lymphoma not applicable Brentuximab vedotin FDA approved Actionable In a Phase II trial that supported FDA approval, Adcetris (brentuximab vedotin) treatment resulted in an objective response rate of 73% (72/102, 33 complete response, 38 partial response) in patients with relapsed or refractory classical Hodgkin's lymphoma following autologous stem cell transplantation (PMID: 25533035; NCT00848926). detail... 25533035
Unknown unknown anaplastic large cell lymphoma not applicable Brentuximab vedotin FDA approved Actionable In a Phase II trial (SGN-35) that supported FDA approval, Adcetris (brentuximab vedotin) treatment resulted in complete remission in 57% (33/58), partial remission in 29% (17/58) of patients with relapsed or refractory systemic anaplastic large cell lymphoma (PMID: 22614995; NCT00866047). 22614995 detail...

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Clinical Trial Phase Therapies Title Recruitment Status
NCT01196208 Expanded access Brentuximab vedotin A Treatment-Option Protocol to Provide Brentuximab Vedotin to Eligible Patients Completing Studies SGN35-005 or C25001 Available
NCT03138499 Phase III Brentuximab vedotin Brentuximab vedotin + Nivolumab Phase III Trial of Nivolumab Plus Brentuximab Vedotin Versus Brentuximab Vedotin Alone in Patients With Advanced Stage Classical Hodgkin Lymphoma, Who Are Relapsed/ Refractory or Who Are Not Eligible for Autologous Stem Cell Transplant, Active, not recruiting
NCT02684292 Phase III Brentuximab vedotin Pembrolizumab Study of Pembrolizumab (MK-3475) vs. Brentuximab Vedotin in Participants With Relapsed or Refractory Classical Hodgkin Lymphoma (MK-3475-204/KEYNOTE-204) Active, not recruiting
NCT01703949 Phase II Brentuximab vedotin Brentuximab vedotin + Nivolumab Brentuximab Vedotin With or Without Nivolumab in Treating Patients With Relapsed or Refractory CD30+ Lymphoma Recruiting
NCT01716806 Phase II Brentuximab vedotin + Nivolumab Bendamustine + Brentuximab vedotin Brentuximab vedotin + Dacarbazine Brentuximab vedotin A Study of Brentuximab Vedotin in Adults Age 60 and Above With Newly Diagnosed Hodgkin Lymphoma (HL) Recruiting
NCT03947255 Phase II Brentuximab vedotin A Study of Retreatment With Brentuximab Vedotin in Subjects With Classic Hodgkin Lymphoma or CD30-expressing Peripheral T Cell Lymphoma Recruiting
NCT02408042 Phase Ib/II Rituximab Carboplatin + Etoposide + Ifosfamide Pembrolizumab Brentuximab vedotin Study of Pembrolizumab With Chemotherapy in Patients With Advanced Lymphoma (PembroHeme) Withdrawn
NCT02098512 Phase Ib/II Brentuximab vedotin Immunotherapy Following Reduced Intensity Conditioning and Allogeneic Stem Cell Transplant for Poor Risk CD30+ Hodgkin Lymphoma Patients Recruiting
NCT03007030 Phase II Brentuximab vedotin Brentuximab Vedotin in Treating Patients With CD30+ Malignant Mesothelioma That Cannot Be Removed by Surgery Recruiting
NCT02588651 Phase II Brentuximab vedotin A Phase II Study of Single Agent Brentuximab Vedotin in Relapsed/Refractory CD30 Low (<10%) Mature T Cell Lymphoma (TCL) Recruiting


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