Millennium highlights updated survival results from the pivotal ADCETRIS ® (brentuximab vedotin) in patients with Hodgkins lymphoma trial in relapse or refractory

-ADCETRIS ® presents promising results to follow responding patients to treatment after a follow-up of 26.5 months, so it could not be determined yet the median overall survival in the study –

– data is just presented at the seventeenth annual meeting of the European Congress of Hematology –

CambridgeMassachusetts (USA).(UU.), June 2012.- the Millennium, the Takeda Oncology Company-owned company, has announced the updated data from the pivotal trial phase II, which discusses the treatment in monotherapy brentuximab vedotin in patients with lymphoma relapse or refractory Hodgkin after a bone marrow transplant. (TAMO). Results from the study are promising to continue responding patients to treatment after a follow-up of 26.5 months, so it could not be determined yet the median overall survival in the study. The data have been recently during an oral presentation at the seventeenth annual meeting of European Hematology Association (EHA), from 14 to 17 June 2012, in Amsterdam. Brentuximab vedotin is an antibody conjugated to a drug, aimed at the receiver CD30, most types of Hodgkin Lymphoma-specific marker.

’patients with Hodgkin’s lymphoma, multiple prior treatments that fall after receiving an autologous bone marrow transplant often have poor prognosis and there is a great need for effective therapeutic options’, argues Dr. Scott Smith, of the Loyola University Medical Center. «these updated results of the pivotal trial on survival are promising and suggest the possibility of brentuximab vedotin play» «an important role in the treatment of patients with relapse or refractory disease».

Long-term results

It is carried out a test pivot with 102 patients presenting Hodgkin’s lymphoma relapse or refractory after undergoing a STUBBLE. The primary endpoint was rate objective response (ORT) according to an independent review. Secondary evaluation criteria included the rate of complete response (CR), duration of response, the progression free survival (PFS), overall survival (OS), the safety and tolerability. When the analysis of long-term follow-up, the median of the observation period was 26.5 months. The data presented by Dr. Smith, are the following:

– as it had previously, the TRO statement was 75% (76, 102 patients), noting a RC in 33% (n = 34).
– at the time of testing the SG medium not been reached after a median of 26.5 months follow-up
-the median of the SlP for all patients was of 5.6 months.
– as had been reported previously, more frequent adverse reactions ( % 20) of any grade were: peripheral sensory neuropathy (47%), fatigue (46%), nausea (42%), infections of the upper respiratory tract (37%), diarrhea (36%), fever (29%, neutropenia (22%), vomiting (22%) and cough (21%).
– between adverse events that occurred in 20% of patients), grade 3 adverse reactions or higher were: neutropenia (20%), sensory neuropathy (9%), fatigue (2%), fever (2%), and diarrhea (1%).

Patients received brentuximab vedotin 1.8 mg per kg of weight every three weeks by intravenous infusion for 30 minutes in the day hospital, up to a total of 16 cycles. The median of cycles of brentuximab vedotin received by patients was nine. The median age of patients in the pivotal trial was 31 years old. Patients received a median of 3.5 (the interval from 1 to 13) pre-treatment antineoplastic systemic, not counting the CHAFF. 71% Of the patients had a primary refractory lymphoma. These patients were defined as patients who had suffered a relapse within three months since they reach complete remission or who had not achieved such a referral. 42% Of patients had not responded to its most recent previous treatment.

About brentuximab vedotin

Brentuximab vedotin is an antibody conjugate composed of a monoclonal anti-CD30, joined by a link to a quimoterapico antibody: the monometilauristatina E (MMAE), through the use of patented technology of Seattle Genetics. Conjugated antibody used an innovative system of union, designed to maintain stable in the bloodstream and release the MMAE once inside tumor cells with receptors CD30 expression.

Brentuximab vedotin is not approved for use outside the United States.UU. The application for approval of brentuximab vedotin for relapse or refractory Hodgkin’s lymphoma and Lymphoma anaplastic large cell systemic (sALCL) was submitted by Takeda Global Research & Development Centre (Europe) and accepted for evaluation by the European Medicines Agency in June 2011.

About Lymphoma hodgkiniano

The general term ’Lymphoma’ refers to a group of neoplasms originating in the lymphatic system. There are two main categories of lymphomas: Hodgkin Lymphoma, non-Hodgkin lymphoma. Hodgkin’s lymphoma is distinguished from other types of lymphomas by the presence of a type of cell called the Reed-Sternberg cells. Reed-Sternberg cells normally express receptors CD30.

Each year more than 30,000 cases of Hodgkin Lymphoma worldwide are diagnosed. Although it is possible to achieve response rates lasting with first-line combination chemotherapy, up to 30% of patients suffer relapses or are refractory to first-line treatment, and have few treatment options more autologous bone marrow transplantation.

On Millennium

Millennium: The Takeda Oncology Company, a major biopharmaceutical company headquartered in Cambridge, Massachusetts (USA).(UU.), sold in United States VELCADE, an inhibitor of the proteasome, which is the first drug in a new class. In addition, it has an important variety of new products under clinical investigation. In May 2008, Takeda Pharmaceutical Company Ltd. acquired Millennium Pharmaceuticals, Inc. The activities of research, development and marketing of the company are dedicated to oncology.