Updated survival data from Takeda’s brentuximab vedotin Phase II trial on HL

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Jun 14 2012

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 17^th 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:

As previously reported, the ORR was 75 percent (76 of 102 patients), with CRs observed in 33 percent of patients (n=34)
The median OS had not been reached after a 26.5 month median follow-up
The median PFS for all patients was 5.6 months
As previously reported, the most common (≥20 percent) adverse events (AEs) of any grade were peripheral sensory neuropathy (47 percent), fatigue (46 percent), nausea (42 percent), upper respiratory tract infection (37 percent), diarrhea (36 percent), pyrexia (29 percent), neutropenia (22 percent), vomiting (22 percent), and cough (21 percent)
Of the AEs that were reported in ≥20 percent of patients, Grade 3 or higher events included neutropenia (20 percent), peripheral sensory neuropathy (9 percent), fatigue (2 percent), pyrexia (2 percent), and diarrhea (1 percent)

Patients received 1.8 milligrams per kilogram of brentuximab vedotin every 3 weeks as a 30-minute outpatient intravenous infusion for up to 16 cycles. 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 1-13) 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: