Interim Phase II Data of Adcetris Against CTCL Announced

Having only recently announced plans for a pivotal Phase III trial investigating Adcetris in the treatment of cutaneous T-cell lymphoma, Seattle Genetics is announcing interim results from an investigator-sponsored Phase II clinical trial investigating Adcetris in patients with relapsed cutaneous T-cell lymphoma. They announced the data at the Society for Investigative Dermatology annual meeting being held May 9-12, 2012 in Raleigh, NC.

Patients involved in this trial had one of two very similar subtypes of CTCL, either mycosis fungoides (MF) or Sezary syndrome (SS), although the huge majority of patients had MF.

Patients had received on average six prior therapies before the start of the trial, including an average of four prior systemic therapies. The trial's primary endpoint was and is clinical response rate, while secondary endpoints include correlation of clinical response with CD30 expression levels, duration of response, progression-free survival and safety.

The study is led by principal investigator Dr. Youn H. Kim, Professor, Department of Dermatology, and Director, Multidisciplinary Cutaneous Lymphoma Program at Stanford University School of Medicine in Stanford, CA. Key findings include:

Partial remission was achieved in 12 of 16 evaluable patients (75 percent). Stable disease was achieved by three patients. One patient had progressive disease.

Source: Genengnews