Seattle Genetics (SGEN) Updates on ADCETRIS Interim Phase II Data
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Seattle Genetics, Inc. (Nasdaq: SGEN) reports interim results from an investigator-sponsored phase II clinical trial of ADCETRIS (brentuximab vedotin) in patients with relapsed cutaneous T-cell lymphoma (CTCL) were presented at the Society for Investigative Dermatology annual meeting being held May 9-12, 2012 in Raleigh, NC. ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30. ADCETRIS has not been approved for use in CTCL.
The trial enrolled CTCL patients with mycosis fungoides (MF) or Sezary syndrome. At the time of data analysis, 17 patients had been enrolled, including 16 with MF and one with Sezary syndrome. Patients had received a median of six prior therapies, including a median of four prior systemic therapies. The primary endpoint of the trial is clinical response rate. 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:
The trial enrolled CTCL patients with mycosis fungoides (MF) or Sezary syndrome. At the time of data analysis, 17 patients had been enrolled, including 16 with MF and one with Sezary syndrome. Patients had received a median of six prior therapies, including a median of four prior systemic therapies. The primary endpoint of the trial is clinical response rate. 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:
- Twelve of 16 evaluable patients (75 percent) achieved a partial remission. Three patients had stable disease and one patient had progressive disease. One patient was not yet evaluable for response.
- Median CD30 expression on lymphoid cells in biopsies of skin lesions was 15 percent. Clinical activity was not dependent on CD30 expression levels.
- Sixty-eight percent of patients maintained response at week 25. Median duration of response had not yet been reached.
- Adverse events were mostly Grade 1 or 2, with the most common related events being peripheral neuropathy (76 percent), fatigue (65 percent), decreased appetite (30 percent) and generalized skin eruption (30 percent). The most common event of Grade 3 or higher was generalized skin eruption (18 percent). One patient experienced Grade 4 peripheral neuropathy. There was one patient death due to respiratory failure presumably secondary to pneumonia.
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