Seattle Genetics, together with partner Takeda Oncology Company, are announcing the initiation of a pivotal, international Phase III clinical trial evaluating the company's recently approved lymphoma treatment Adcetris (formerly known as SGN-35) against cutaneous T-cell lymphoma.
Specifically, the trial will evaluate the antibody drug conjugate (ADC) Adcetris in patients with CD30-expressing cutaneous T-cell lymphoma who have undergone at least one prior systemic therapy. That means the treatment must have been something affecting the whole body system, as opposed to a localized or topical treatment.
The clinical trial will recruit patients in the US, Brazil, Australia and across Europe, and it is being conducted under a Special Protocol Assessment from the US Food & Drug Administration.
"Data from patients with cutaneous lesions observed in our pivotal trial in systemic anaplastic large cell lymphoma (sALCL) and interim data from investigator-sponsored trials in CTCL with ADCETRIS provide a strong rationale for initiating this phase 3 trial," said Thomas C. Reynolds, M.D., Ph.D., Chief Medical Officer, Seattle Genetics.
"CTCL is an important part of our development plan to broadly evaluate ADCETRIS in CD30-expressing malignancies. This trial complements many other ongoing and planned trials for patients in need, including two additional phase 3 trials for front-line Hodgkin lymphoma (HL) and front-line mature T-cell lymphomas expected to start by late 2012 or early 2013."