|Seattle Genetics Announces Data from ADCETRIS™ in Cutaneous T-Cell Lymphoma and Peripheral T-Cell Lymphoma|
-Interim Data Demonstrate 65 Percent Response Rate in Patients with Relapsed CTCL-
-Two Case Studies Provide First Report of Activity and Tolerability in PTCL-NOS Patients-
Investigator-Sponsored Phase II Trial in CTCL
At the time of data analysis, 17 of 23 enrolled patients had received at
least two doses of ADCETRIS and were evaluable for response. All
patients had relapsed CD30-positive cutaneous lymphoproliferative
disorders, including lymphomatoid papulosis (LyP), primary cutaneous
anaplastic large cell lymphoma (pcALCL) or mycosis fungoides (MF).
Patients treated in this trial receive 1.8 milligrams per kilogram
(mg/kg) of ADCETRIS every three weeks for up to a maximum of eight
doses. Patients who achieve partial remission or stable disease are
eligible to receive an additional eight doses. Key findings, which were
presented by Dr.
PTCL Case Studies
Data were also presented from case studies of two patients with relapsed CD30-positive PTCL-NOS who were enrolled in phase I trials of ADCETRIS. PTCL-NOS is associated with a poor prognosis and there is no well-established standard of care. Both patients were heavily pretreated, including prior autologous stem cell transplant. The first patient achieved a PR with progression-free survival of eight months and overall survival of 22 months. Adverse events considered related to ADCETRIS were Grade 2 sensory neuropathy in the fingertips and Grade 3 fatigue. The second patient achieved a CR which is still ongoing with a duration of more than 19 months. The patient had Grade 3 anemia and other Grade 1 adverse events, none of which were considered by the investigator to be related to ADCETRIS.
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 was granted accelerated approval by the
ADCETRIS is not approved for use outside
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
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.