|Seattle Genetics Announces Data from Investigator Trial of ADCETRIS™ in Relapsed Cutaneous T-Cell Lymphoma|
-Interim Data Demonstrate 75 Percent Response Rate in Patients with Relapsed 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
This is the second data set reported with ADCETRIS in CTCL patients. At
Lymphoma is a general term for a group of cancers that originate in the
lymphatic system. There are two major categories of lymphoma: Hodgkin
lymphoma and non-Hodgkin lymphoma. Cutaneous lymphomas are a category of
non-Hodgkin lymphomas that primarily involve the skin. According to the
ADCETRIS (brentuximab vedotin) is an ADC comprising an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E (MMAE), utilizing Seattle Genetics’ proprietary technology. The ADC employs a linker system that is designed to be stable in the bloodstream but to release MMAE upon internalization into CD30-expressing tumor cells.
ADCETRIS (brentuximab vedotin) received accelerated approval from the
ADCETRIS is not approved for use outside
U.S. Important Safety Information
Progressive multifocal leukoencephalopathy (PML): JC virus infection resulting in PML and death can occur in patients receiving ADCETRIS.
Concomitant use of ADCETRIS and bleomycin is contraindicated due to pulmonary toxicity.
Warnings and Precautions:
ADCETRIS was studied as monotherapy in 160 patients in two phase 2 trials. Across both trials, the most common adverse reactions (≥20%), regardless of causality, were neutropenia, peripheral sensory neuropathy, fatigue, nausea, anemia, upper respiratory tract infection, diarrhea, pyrexia, rash, thrombocytopenia, cough and vomiting.
Patients who are receiving strong CYP3A4 inhibitors concomitantly with ADCETRIS should be closely monitored for adverse reactions.
Certain of the statements made in this press release are
forward-looking, such as those, among others, relating to the
therapeutic potential of ADCETRIS and initiation of future clinical
trials. Actual results or developments may differ materially from those
projected or implied in these forward-looking statements. Factors that
may cause such a difference include the inability to show sufficient
activity in clinical trials and the risk of adverse events as ADCETRIS
advances in such clinical trials. In addition, data from our clinical
trials, including our pivotal trials which were the basis for
Seattle Genetics, Inc.