Seattle Genetics Announces Four-Year Survival Data From ADCETRIS Trial In ALCL

By RTT News, December 07, 2014, 12:17:00 PM EDT

(RTTNews.com) - Seattle Genetics Inc ( SGEN ) and Takeda Pharmaceutical Co Ltd on Sunday announced four-year overall survival (OS) data from the ADCETRIS (brentuximab vedotin) pivotal Phase 2 clinical trial in relapsed or refractory systemic anaplastic large cell lymphoma (ALCL).

ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, which is expressed in classical Hodgkin lymphoma (HL) and systemic ALCL, a type of T-cell lymphoma. At a median follow up of 46.3 months, the estimated four-year survival rate was 64 percent. The data were presented at the 56th American Society of Hematology (ASH) Annual Meeting and Exposition taking place in San Francisco, CA, December 6-9, 2014.

"Historical outcomes for patients with relapsed T-cell lymphoma, including systemic ALCL have been poor, with a median overall survival of 5.5 months and a median progression-free survival of 3.1 months. The four-year survival data from the pivotal trial in systemic ALCL demonstrate ADCETRIS' activity in the treatment of this disease, with an estimated four-year survival rate of 64 percent and a median progression-free survival of 20 months," said Clay Siegall, Chief Executive Officer of Seattle Genetics.

"These encouraging data show durable, long-term responses in the relapsed systemic ALCL treatment setting and support the evaluation of ADCETRIS in earlier lines of therapy, including in the ongoing Phase 3 ECHELON-2 clinical trial in frontline mature T-cell lymphoma."

A pivotal, single-arm clinical trial was conducted in 58 relapsed or refractory systemic ALCL patients to assess the efficacy and safety of single-agent ADCETRIS. In addition, the trial was designed to determine duration of response, progression-free survival (PFS) and overall survival (OS). Patients received 1.8 milligrams per kilogram (mg/kg) of ADCETRIS administered through a 30-minute intravenous infusion every three weeks for up to 16 cycles. As previously reported, 86 percent of patients on the trial achieved an objective response, including 59 percent with a complete response (CR) and 28 percent with a partial response (PR).

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Seattle Genetics Announces Four-Year Survival Data From ADCETRIS Trial In ALCL