Takeda Highlights Data from Clinical Trial Examining the Use of ADCETRIS® (Brentuximab Vedotin) in Pediatric Patients

CHICAGO & OSAKA, Japan--(BUSINESSWIRE)-- Takeda Pharmaceutical Company Limited (TSE:4502) today announced interim data from a Phase 1/2, open-label, multicenter study with ADCETRIS (brentuximab vedotin) in pediatric patients diagnosed with CD30-positive relapsed or refractory Hodgkin lymphoma (HL) or relapsed or refractory systemic anaplastic large cell lymphoma (sALCL). Data were presented from the Phase 1 portion of the study, which evaluated the safety, maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D), and pharmacokinetics (PK) of ADCETRIS. The results were reported during a poster presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting held May 31 June 4, 2013 in Chicago, IL.

ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, a defining marker of classical HL and sALCL.

This is the first clinical trial examining the use of ADCETRIS in pediatric patients, said Kathleen Neville, M.D., M.S., Director, Experimental Therapeutics in Pediatric Cancer, Childrens Mercy Hospitals and Clinics, Kansas City, MO. There is an unmet medical need for children diagnosed with relapsed or refractory HL or relapsed or refractory sALCL. We are encouraged by these early results and look forward to reporting data from the Phase 2 portion of the study when they are available.

Phase I/II Study of Brentuximab Vedotin in Pediatric Patients with Relapsed or Refractory Hodgkin Lymphoma or Systemic Anaplastic Large Cell Lymphoma: Interim Phase I Safety Data

The poster presentation featured interim data from the Phase 1 portion of the study, which evaluated 12 pediatric patients aged 2 to

Data, presented by Anna R.K. Franklin, M.D., Children's Cancer Hospital, MD Anderson Cancer Center, Houston, TX., included:

The median age of the patients was 14.5 years. Ten patients were diagnosed with relapsed or refractory HL and two patients were diagnosed with relapsed or refractory sALCL. Participants received a median of 7 cycles (range, 114) of ADCETRIS by intravenous infusion once every 21 days starting with 1.4 mg/kg escalating to 1.8 mg/kg.

Details of the poster presentation are as follows:

This clinical trial is part of the Pediatric Investigational Plan approved by the Pediatric Committee of the European Medicines Agency. The Phase 2 portion of the study is ongoing and results will be presented at a later date. For more information about the trial please visit http://www.clinicaltrials.gov.

About ADCETRIS(brentuximab vedotin) ADCETRIS (brentuximab vedotin) is the first and only targeted CD30 antibody-drug conjugate (ADC) being evaluated in a variety of CD30-expressing malignancies including Hodgkin lymphoma (HL) and systemic anaplastic large cell lymphoma (sALCL). The ADC utilizes Seattle Genetics proprietary technology, which employs a linker system designed to be stable in the bloodstream but to release monomethyl auristatin E (MMAE) upon internalization into CD30-expressing tumor cells.

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Takeda Highlights Data from Clinical Trial Examining the Use of ADCETRIS® (Brentuximab Vedotin) in Pediatric Patients