5:45AM Seattle Genetics and Takeda (TKPYY) unit Millennium highlight data from ADCETRIS trial in patients with newly diagnosed systemic anaplastic large cell lymphoma (SGEN) 26.94 : Millennium, a wholly owned subsidiary of Takeda Pharmaceutical (TKPYY), and Seattle Genetics (SGEN), announce preliminary data from one arm of a three arm phase I, open-label, multicenter study designed to determine the safety and activity of sequential and combination treatment approaches of brentuximab vedotin with CHOP1 or CH-P chemotherapy in newly diagnosed patients with CD30-positive mature T- and NK- cell lymphomas. The data, presented included: The most common (=30 percent of total patients) adverse events, regardless of severity, were nausea (77%), peripheral sensory neuropathy (77%), vomiting (54%), constipation (46%) and fatigue (46%). The most common (=10 percent of total patient) AEs of Grade 3 or higher were anemia, constipation, fatigue, peripheral sensory neuropathy and febrile neutropenia, each occurring in 15 percent of patients. Of the 13 evaluable patients on Arm 1 of the study, 100% achieved an objective response following the first two cycles of treatment with single-agent brentuximab vedotin, including five CRs and eight PRs. After eight cycles of sequential therapy, including two cycles of brentuximab vedotin followed by six cycles of CHOP, 11 patients had an objective response, including eight CRs and three PRs. Objective responses were generally maintained in patients treated with single-agent brentuximab vedotin following CHOP, including seven of nine evaluable patients with CRs at Cycle 12 and five of five evaluable patients with CRs at Cycle 16.
