Seattle Genetics has initiated phase-II clinical trial of SGN-35 for patients with relapsed or refractory systemic anaplastic large cell lymphoma (ALCL). SGN-35 is an antibody-drug conjugate (ADC) that empowers antibodies by linking them to potent cell-killing drugs.
The single-arm phase-II trial will assess efficacy and safety of SGN-35 in 55 patients. Patients will receive 1.8mg/kg of SGN-35 every three weeks. The primary endpoint of the trial will be an objective response rate determined by an independent review facility. Secondary endpoints include duration of response, progression-free survival, overall survival, and tolerability.
Seattle Genetics is also conducting a pivotal trial of SGN-35 for Hodgkin lymphoma, under a Special Protocol Assessment (SPA) with FDA.
Clay Siegall, President and CEO, Seattle Genetics, said: “We have observed promising activity in ALCL patients in our phase I trials, notably six out of seven patients treated with SGN-35 have achieved a complete response.”
“SGN-35 could become an important therapeutic option for patients who relapse or fail to respond to the standard front-line chemotherapy regimen, and we believe that systemic ALCL may offer an additional registration pathway for SGN-35,” he added.