Adcetris brentuximab vedotin: Interim Phase I data

Seattle Genetics reported interim data from 17 evaluable patients with newly diagnosed systemic ALCL and other CD30-positive mature T cell lymphomas in an open-label Phase I trial evaluating 1.8 mg/kg Adcetris every 3 weeks given either sequentially with CHOP chemotherapy (cyclophosphamide, doxorubicin, vincristine and prednisone) or concurrently with CH-P chemotherapy (cyclophosphamide, doxorubicin and prednisone). In 12 evaluable patients in the sequential Adcetris-CHOP chemotherapy regimen, all patients achieved an objective response, including 4 complete remissions and 8 partial remissions, after 2 cycles of single-agent Adcetris. Of the 6 evaluable patients who completed 6 cycles of subsequent CHOP chemotherapy, 4 achieved a complete remission and 2 achieved a partial remission. In 5 evaluable patients in the concurrent Adcetris-CH-P chemotherapy regimen who completed the full 6-cycle course of combination treatment, all 5 achieved a complete remission. The trial has enrolled 32 patients. Data were presented at the T-Cell Lymphoma Forum in San Francisco. Seattle Genetics plans to start Phase III testing of Adcetris as first-line treatment of mature T cell lymphomas in late 2012 or early 2013.

Last August, FDA granted accelerated approval to a pair of BLAs from Seattle Genetics for Adcetris to treat Hodgkin's lymphoma and ALCL. As part of the approval, the company is required to conduct 2 Phase III confirmatory trials, 1 for each indication. Specifically, Adcetris is indicated for Hodgkin's lymphoma after failure of autologous stem cell transplant (ASCT) or after failure of >=2 prior multi-agent chemotherapy regimens in patients who are not ASCT candidates. For ALCL, the drug is indicated after failure of >=1 prior multi-agent chemotherapy regimen (see BioCentury, Aug. 22, 2010). The product is under review in the EU for the indications. ...