Adcetris brentuximab vedotin: Additional Phase I data

Additional data from 47 evaluable patients with newly diagnosed Hodgkin's lymphoma in an open-label, dose-escalation, North American Phase I trial showed that the rate of complete remissions was 95% in patients receiving Adcetris plus ABVD ( adriamycin, bleomycin, vinblastine and dacarbazine) (n=22) and 96% in patients receiving Adcetris plus AVD chemotherapy (n=25). There were no dose-limiting toxicities (DLTs) observed at the maximum planned dose of 1.2 mg/kg Adcetris every 2 weeks. The most common adverse events reported were nausea, neutropenia, peripheral sensory neuropathy, vomiting and fatigue. Adverse events >=grade 3 that occurred in >=1 patients were neutropenia, anemia, febrile neutropenia, pulmonary toxicity and peripheral neuropathy. No patients in the Adcetris plus AVD arm experienced pulmonary toxicity while 11 patients in the Adcetris plus ABVD arm had a pulmonary toxicity event. Furthermore, 5 patients in the ABVD group and 2 patients in the AVD group discontinued due to an adverse event. The trial enrolled 51 patients. Data were presented at the American Society of Hematology meeting in Atlanta.

In 2011, Seattle Genetics reported interim data from the trial showing that 10 patients receiving Adcetris plus ABVD chemotherapy had an event of pulmonary toxicity compared to 0 patients receiving Adcetris plus AVD. As a result, Seattle Genetics said it did not recommend concomitant use of Adcetris with bleomycin and patients were no longer being treated in the ABVD cohorts (see BioCentury, Dec. 19, 2011). ...