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Brentuximab Vedotin Demonstrates Significant Efficacy in Relapsed or Refractory Anaplastic Large Cell Lymphoma

Strategic Insights

— 2 min read

Seattle Genetics and Millennium announced positive top-line results from a phase II clinical trial of single-agent brentuximab vedotin in relapsed or refractory systemic anaplastic large cell lymphoma (ALCL) patients. The trial achieved an objective response rate of 86%, with 80% of patients in the trial experiencing some form of response. The median duration of response has not yet been reached at a median follow-up of approximately six months. The safety profile of brentuximab vedotin in this trial was generally consistent with prior clinical trial experience.

Key Takeaways:

  • 86% of patients in the phase II clinical trial achieved an objective response as assessed by an independent central review.
  • The median duration of response has not yet been reached at a median follow-up of approximately six months.
  • The safety profile of brentuximab vedotin in the trial was generally consistent with prior clinical trial experience.
  • Brentuximab vedotin has been granted orphan drug designation by the FDA and European Medicines Agency (EMA) for the treatment of HL and ALCL.
  • The approach used in brentuximab vedotin, which combines an anti-CD30 monoclonal antibody with a potent, synthetic drug payload, is intended to spare non-targeted cells and thus may help minimize the potential toxic effects of traditional chemotherapy.
  • Seattle Genetics and Millennium are jointly developing brentuximab vedotin, with Seattle Genetics having U.S. and Canadian commercialization rights and the Takeda Group having rights to commercialize brentuximab vedotin in the rest of the world.
  • The companies plan to discuss regulatory next steps with the U.S. Food and Drug Administration (FDA) later this year with the goal of including both ALCL and Hodgkin lymphoma indications in the Biologics License Application (BLA) submission planned for the first half of 2011.
  • The companies are conducting a phase III clinical trial (the AETHERA trial) for patients at high risk of residual Hodgkin lymphoma following autologous stem cell transplant, a phase II retreatment trial for relapsed patients who previously responded to brentuximab vedotin, and a phase I combination trial for front-line treatment of Hodgkin lymphoma.

Statistics:

  • 86% of patients in the phase II clinical trial achieved an objective response as assessed by an independent central review.
  • 80% of patients in the trial experienced some form of response.
  • The median duration of response has not yet been reached at a median follow-up of approximately six months.
  • Brentuximab vedotin has been granted orphan drug designation by the FDA and European Medicines Agency (EMA) for the treatment of HL and ALCL.
  • The safety profile of brentuximab vedotin in the trial was generally consistent with prior clinical trial experience.

Sources:

  • Seattle Genetics press release, November 23, 2010
  • Millennium Pharmaceuticals press release, November 23, 2010
  • ASH Abstract, 2010
  • Cheson, 2007

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