Seattle Genetics and Millennium Complete Enrollment in Phase II Trial of Brentuximab Vedotin

Strategic Insights -

Seattle Genetics, Inc. and Millennium: The Takeda Oncology Company have completed enrollment in a phase II clinical trial of brentuximab vedotin (SGN-35), an antibody-drug conjugate (ADC) targeted to CD30, for relapsed or refractory systemic anaplastic large cell lymphoma (ALCL). The trial enrolled 55 patients and will provide preliminary data in the second half of 2010, guiding the next steps towards bringing this promising ADC to ALCL patients. The companies believe that systemic ALCL may offer an additional registration pathway for brentuximab vedotin.

Key Takeaways:

  • The phase II trial of brentuximab vedotin for relapsed or refractory systemic ALCL has completed enrollment in less than a year, driven by strong interest among clinical investigators and the ALCL patient community.
  • The trial is a single-agent, single-arm study evaluating 55 patients with relapsed or refractory systemic ALCL, who receive 1.8 milligrams per kilogram of brentuximab vedotin every three weeks for up to approximately one year.
  • The primary endpoint of the study is objective response rate determined by independent review, and secondary endpoints include duration of response, progression-free survival, overall survival, and tolerability.
  • Of seven systemic ALCL patients treated with brentuximab vedotin in phase I clinical trials, six (86 percent) achieved a complete remission, and the majority of adverse events were Grade 1 and 2, with the most common being fatigue, fever, peripheral neuropathy, diarrhea, and nausea.
  • Seattle Genetics and Millennium are developing brentuximab vedotin in collaboration, with Seattle Genetics holding U.S. and Canadian development and commercialization rights and the Takeda Group holding rights to develop and commercialize the ADC in the rest of the world.
  • The companies are funding joint development costs for brentuximab vedotin on a 50:50 basis, except in Japan where the Takeda Group will be solely responsible for development costs.

Statistics:

  • 55 patients were enrolled in the phase II trial of brentuximab vedotin for relapsed or refractory systemic ALCL.
  • The primary endpoint of the study is objective response rate determined by independent review.
  • 86 percent of seven systemic ALCL patients treated with brentuximab vedotin in phase I clinical trials achieved a complete remission.
  • The majority of adverse events in the phase I trials were Grade 1 and 2, with the most common being fatigue, fever, peripheral neuropathy, diarrhea, and nausea.

Sources:

  • Seattle Genetics, Inc. (Nasdaq: SGEN)
  • Millennium: The Takeda Oncology Company
  • Takeda Pharmaceutical Company Limited (TSE:4502)
  • NewsRx.com
  • Cancer Weekly