Date: 2016-11-08
Type of
information: Completion of patient enrollment
phase: 3
Announcement: completion of patient enrollment
Company: Millenium Pharmaceuticals (USA - MA) Seattle Genetics (USA - WA), wholly owned subsidiaries of Takeda Pharmaceutical (Japan)
Product: Adcetris® (brentuximab vedotin)
Action
mechanism:
- monoclonal antibody/antibody drug conjugate (ADC). Adcetris® (brentuximab vedotin) is an antibody-drug conjugate (ADC) comprising an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E (MMAE). The ADC employs a linker system that is designed to be stable in the bloodstream but to release MMAE upon internalisation into CD30-expressing tumor cells. The CD30 antibody part of the product acts as a carrier for the cytotoxic substance. When the antibody attached by the linker to the cytotoxin attaches to the CTCL cells, it is taken up by the cells. Once inside the cancer cells, the linker is cut and the cytotoxic molecule, monomethyl auristatin E, gets released and stops cell division. The cancer cells are then expected to undergo programmed cell death.
Disease: CD30-positive mature T-cell lymphoma (MTCL)
Therapeutic
area: Cancer - Oncology
Country: Australia, Canada, Czech Republic, Denmark, France, Germany, Hungary, Israel, Italy, Republic of Korea, Poland, Romania, Spain, Taiwan, UK, USA
Trial
details:
- The double-blind, placebo-controlled global phase 3 trial is investigating ADCETRIS plus CHP versus CHOP as frontline therapy in patients with CD30-positive MTCL. The primary endpoint is progression-free survival per independent review facility assessment using the Cheson 2007 Revised Response Criteria for Malignant Lymphoma. Secondary endpoints include overall survival, complete remission rate and safety. The multi-center trial is being conducted in North America, Europe and Asia. The study enrolled 452 patients, with approximately 225 patients per treatment arm. Data from the trial will be available when a pre-specified number of progression-free survival events have occurred. (NCT01777152)
Latest
news:
- • On November 8, 2016, Seattle Genetics and Takeda Pharmaceutical announced completion of patient enrollment in the ECHELON-2 clinical trial. ECHELON-2 is a global phase 3 randomized trial evaluating Adcetris® (brentuximab vedotin) as part of a frontline combination chemotherapy regimen in patients with previously untreated CD30-positive mature T-cell lymphoma (MTCL). Patients in ECHELON-2 were randomized to receive a novel combination regimen consisting of Adcetris® plus cyclophosphamide (C), doxorubicin (H) and prednisone (P) (referred to as A+CHP) versus cyclophosphamide, doxorubicin, vincristine (O) and prednisone (referred to as CHOP), the recognized standard of care treatment regimen for frontline MTCL. The trial enrolled 452 patients. The ECHELON-2 trial is being conducted under a Special Protocol Assessment (SPA) agreement from the FDA and the trial also received European Medicines Agency (EMA) scientific advice.
Is
general: Yes
