Seattle Genetics Initiates Phase II Trial of SGN-35 for Anaplastic Large Cell Lymphoma
News Jun 19, 2009
Seattle Genetics, Inc. has announced that it has initiated a 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 utilizes Seattle Genetics’ proprietary technology to empower antibodies by linking them to potent cell-killing drugs.
“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,” said Clay B. Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. “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.”
The single-arm phase II trial will assess efficacy and safety of single-agent SGN-35 in 55 patients with relapsed or refractory systemic ALCL. Patients will receive 1.8 milligrams per kilogram of SGN-35 every three weeks.
The primary endpoint of the trial will be objective response rate determined by an independent review facility. Secondary endpoints include duration of response, progression-free survival, overall survival and tolerability. The company plans to enroll patients at more than 30 sites in the U.S., Canada and Europe.
Seattle Genetics is also conducting a pivotal trial of SGN-35 for Hodgkin lymphoma under a Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration (FDA). Data from two phase I trials of SGN-35 were reported in June at the American Society of Clinical Oncology annual meeting and the 14th Congress of the European Hematology Association.
In both phase I trials, relapsed or refractory Hodgkin lymphoma and systemic ALCL patients treated with single-agent SGN-35 achieved multiple objective responses at generally well-tolerated doses. The majority of adverse events were Grade 1 and 2, with the most common being fatigue, fever, peripheral neuropathy, diarrhea and nausea.
SGN-35 is an ADC comprising an anti-CD30 antibody attached by an enzyme cleavable linker to a potent, synthetic drug payload, monomethyl auristatin E (MMAE), using Seattle Genetics’ proprietary technology. The ADC is designed to be stable in the bloodstream, but to release MMAE upon internalization into CD30-expressing tumor cells, resulting in targeted cell-killing.
New Partnership to Provide Bioanalytical and DMPK ServicesNews
Concept Life Sciences, the integrated drug discovery, development and analytical services company, and Alderley Analytical, bioanalytical Contract Research Organisation (CRO), today announced they have signed a partnership agreement to provide high-value bioanalytical and DMPK study services.