Seattle Genetics (SGEN) Says ADCETRIS Has Clinically Meaningful Response, Safety Profile

Seattle Genetics, Inc. (Nasdaq: SGEN) reported data demonstrating that prolonged treatment with ADCETRIS beyond 16 cycles of therapy was associated with clinically meaningful durations of response with a manageable safety profile. In addition, data were presented showing that ADCETRIS is a viable option for reducing tumor burden prior to allogeneic stem cell transplant. The data were presented at the 53rd American Society of Hematology (ASH) Annual Meeting and Exposition being held December 10-13, 2011 in San Diego, CA. ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30.

From the release:

"Prolonged Treatment with Brentuximab Vedotin in Patients with Relapsed or Refractory Hodgkin Lymphoma (HL) or Systemic Anaplastic Large Cell Lymphoma (sALCL) (Abstract #3711)

Data were presented from a retrospective analysis of relapsed Hodgkin lymphoma and sALCL patients who received greater than 16 cycles of ADCETRIS in a treatment extension study. Seventeen patients were included in the analysis, and median duration of treatment was 17.3 months (approximately 24 cycles of every three week dosing). ADCETRIS is approved for treatment until a maximum of 16 cycles, disease progression or unacceptable toxicity. Key findings include:

• The overall objective response rate was 88 percent, including 76 percent complete remissions and 12 percent partial remissions.
  
  
• The median time to objective response was 2.5 months. Median duration of objective response has not been reached (range 8.3 to 23.2+ months).
  
  
• ADCETRIS was generally well-tolerated, with the most common adverse events being peripheral neuropathy (71 percent), upper respiratory infection (53 percent) and fatigue (47 percent).
  
  
• In this case series, prolonged treatment with ADCETRIS was associated with clinically meaningful durations of response without worsening of toxicity over time.

Allogeneic Transplant Following Brentuximab Vedotin Treatment in Patients with Relapsed or Refractory CD30+ Lymphomas (Abstract #3091)

Data were presented describing the outcome of 15 patients with relapsed Hodgkin lymphoma or sALCL who underwent an allogeneic stem cell transplant as their first subsequent therapy after participation in a pivotal trial of ADCETRIS. ADCETRIS is not indicated to enable a subsequent allogeneic stem cell transplant. Key findings include:

• Fifteen patients who achieved an objective response with ADCETRIS (12 patients with a complete remission and three patients with a partial remission) subsequently received an allogeneic transplant.
  
  
• Ten of 15 patients (67 percent) remained in remission following subsequent allogeneic transplant. Three patients progressed and two died.
  
  
• Median progression-free survival and overall survival have not been reached after a median duration of follow-up of approximately 20 months (range 8 to 24 months).
  
  
• The data demonstrate that ADCETRIS may be an option for reducing tumor burden in advance of an allogeneic stem cell transplant.

Preclinical Activity of Brentuximab Vedotin in Primary Effusion Lymphoma (PEL) (Abstract #3728)

In a poster session today, Dr. Shruti Bhatt from the University of Miami Miller School of Medicine describes preclinical data on the expression of CD30 in primary effusion lymphoma (PEL). PEL is an aggressive subtype of non-Hodgkin lymphoma that is commonly diagnosed in HIV-positive patients. The data demonstrate the expression of CD30 on PEL cell lines and primary tumor samples. ADCETRIS induced apoptosis in PEL cell lines and extended survival in a preclinical PEL model. ADCETRIS is not indicated for the treatment of PEL."

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