Brentuximab Vedotin Shows Promising Results in Phase II Trial for Relapsed or Refractory ALCL

Seattle Genetics and Millennium: The Takeda Oncology Company announced positive results from a phase II clinical trial of brentuximab vedotin (SGN-35) in relapsed or refractory systemic anaplastic large cell lymphoma (ALCL). The trial demonstrated an 86% objective response rate, with 53% of patients achieving a complete remission. Tumor reductions were achieved in 97% of patients, and the most common adverse events were nausea, peripheral sensory neuropathy, fatigue, fever, and diarrhea.

Key Takeaways:

86% of patients achieved an objective response, with 53% achieving a complete remission.
Tumor reductions were achieved in 97% of patients.
The most common adverse events were nausea, peripheral sensory neuropathy, fatigue, fever, and diarrhea.
Brentuximab vedotin has been granted orphan drug designation by the FDA and European Medicines Agency (EMA) for the treatment of Hodgkin lymphoma and ALCL.
The median age of patients in the phase II trial was 52 years, and 62% of patients were primary refractory to front-line chemotherapy.
72% of patients were ALK-negative, and 26% had failed prior autologous stem cell transplant.
Seattle Genetics plans to submit a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) in the first quarter of 2011, and Millennium has initiated discussions with European regulators to support the submission of a Marketing Authorization Application to the European Medicines Agency (EMA) in the first half of 2011.

Statistics:

86% objective response rate (Cheson 2007 criteria)
53% complete remission rate
97% tumor reduction rate
52 years median age
62% primary refractory to front-line chemotherapy
72% ALK-negative
26% failed prior autologous stem cell transplant

Sources:

American Society of Hematology (ASH) Annual Meeting
Seattle Genetics press release
Millennium: The Takeda Oncology Company press release