Seattle Genetics announced interim results from an investigator-sponsored Phase 2 clinical trial of Adcetris (brentuximab vedotin) in patients with relapsed cutaneous T-cell lymphoma (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.

Key findings include:

  • Twelve of 16 evaluable patients (75%) 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%. 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.

Brentuximab vedotin is an antibody-drug conjugate (ADC) comprising an anti-CD30 antibody attached by an enzyme cleavable linker to a 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 a targeted cell-killing effect.  Adcetris is approved for two indications: (1) the treatment of patients with Hodgkin lymphoma after failure of autologous stem cell transplant (ASCT) or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not ASCT candidates, and (2) the treatment of patients with systemic anaplastic large cell lymphoma (sALCL) after failure of at least one prior multi-agent chemotherapy regimen.

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