Seattle Genetics, maker of the antibody drug conjugate Adcetris, has announced the initiation of a pair of Phase I clinical trials testing the company's latest oncology candidate, SGN-CD19A.
Each trial will serve to assess the safety and anti-tumor response of SGN-CD19A against both CD19-positive acute lymphoblastic leukemia (ALL) as well as B-cell non-Hodgkin's lymphoma (HL).
Primary endpoints of the trials include determining the maximum tolerated dose as well as investigating the safety of SGN-CD19A. Secondary endpoints will include antitumor activity, pharmacokinetics, progression-free survival (PFS) and overall survival (OS).
Adcetris, the company's only approved drug, generated more than $100 million during the first nine months of 2012 and is now approved under Health Canada's Notice of Compliance with conditions (NOC/c) for the treatment of relapsed or refractory Hodgkin's as well as systemic anaplastic large cell lymphoma (sALCL) - conditions for which it is approved by the U.S. FDA as well.
Most recently, a global phase III study known as ECHELON-2 was launched, investigating Adcetris plus chemotherapy as a potential first-line therapy against CD30-positive mature T-cell lymphoma (MTCL).
ECHELON-2 was initiated in January.
Source: Leukemia & Lymphoma Society