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 26.5 months. Data, to be presented by Dr. Smith, include: