Millennium Highlights Updated Survival Data from ADCETRIS® (Brentuximab Vedotin) Pivotal Trial in Patients with …


Millennium: The Takeda Oncology Company, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited (TSE:4502), today announced updated survival data from a pivotal Phase II clinical trial of single-agent brentuximab vedotin in patients with relapsed or refractory Hodgkin lymphoma (HL) after autologous stem cell transplant (ASCT) showing that the median overall survival has not been reached after a 26.5 month median follow-up. The data will be reported during an oral presentation at the 17th European Hematology Association (EHA) Annual Meeting being held June 14-17, 2012 in Amsterdam, Netherlands. Brentuximab vedotin is an antibody-drug conjugate (ADC) directed to CD30, a defining marker of the majority of types of HL.

Heavily pretreated Hodgkin lymphoma patients who relapse following autologous stem cell transplant often have a poor prognosis and there is a high unmet medical need for effective treatment options, said Scott Smith M.D., Ph.D., Loyola University Medical Center. These updated overall survival results from the pivotal trial are encouraging and suggest that brentuximab vedotin may play an important role in the treatment of patients with relapsed or refractory disease.

Long-term Follow-up Results of an Ongoing Pivotal Study of Brentuximab Vedotin in Patients with Relapsed or Refractory Hodgkin Lymphoma

A pivotal trial was conducted in 102 patients with relapsed or refractory HL after ASCT. The primary endpoint was objective response rate (ORR) per independent review. The secondary endpoints were complete remission (CR) rate, duration of response, progression-free survival (PFS), overall survival (OS), and safety and tolerability. At the time of the long-term follow-up analysis, the median observation time from first dose was 26.5months. Data, to be presented by Dr. Smith, include:

Patients received 1.8milligrams per kilogram of brentuximab vedotin every 3 weeks as a 30-minute outpatient intravenous infusion for up to 16cycles. Patients received a median of nine cycles of brentuximab vedotin while on trial. The median age of patients in the pivotal trial was 31 years. Enrolled patients had received a median of 3.5 (range 113) prior cancer-related systemic therapies, excluding ASCT. Seventy-one percent of patients had primary refractory disease, defined in the study protocol as patients who relapsed within three months of attaining CR or failed to achieve a CR, and 42 percent had not responded to their most recent prior therapy.

Details of the oral presentation are as follows:

About Brentuximab Vedotin

Brentuximab vedotin is an ADC comprising an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E (MMAE), utilizing Seattle Genetics proprietary technology. The ADC employs a linker system that is designed to be stable in the bloodstream but to release MMAE upon internalization into CD30-expressing tumor cells.

Brentuximab vedotin is not approved for use outside the United States. The marketing authorization application for brentuximab vedotin in relapsed or refractory Hodgkin lymphoma and sALCL, filed by Takeda Global Research & Development Centre (Europe), was accepted for review by the European Medicines Agency for review in June 2011.

Millennium Highlights Updated Survival Data from ADCETRIS® (Brentuximab Vedotin) Pivotal Trial in Patients with ...

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