|Millennium and Seattle Genetics Initiate Global Phase 3 Trial of ADCETRIS™ in Patients with CD30-Expressing Relapsed Cutaneous T-cell Lymphoma|
-Trial Conducted Under Special Protocol Assessment with
-Study Includes Evaluation of Companion Diagnostic Test for CD30 Identification-
“Millennium is pleased to announce the initiation of the pivotal trial
of ADCETRIS in patients with relapsed CD30-expressing CTCL. We recognize
this as a significant milestone in our efforts to explore the potential
of this targeted therapy in other indications,” said
“Data from patients with cutaneous lesions observed in our pivotal trial
in systemic anaplastic large cell lymphoma (sALCL) and interim data from
investigator-sponsored trials in CTCL with ADCETRIS provide a strong
rationale for initiating this phase 3 trial,” said
CD30 is a member of the tumor necrosis factor receptor (TNFR) family and
is a characteristic cell surface receptor for activated T-cells and
B-cells, including the malignant cells of HL and sALCL. According to
published literature, up to 50 percent of CTCL patients’ lesions express
CD30(1-3). Under a previously announced collaboration
The study is a randomized, open-label, phase 3 trial of ADCETRIS versus investigator’s choice of methotrexate or bexarotene in patients with CD30-positive CTCL, including those with primary cutaneous anaplastic large cell lymphoma (pcALCL) or mycosis fungoides (MF). The primary endpoint of the study is overall response rate (ORR), lasting at least 4 months, with ADCETRIS in patients with CD30-positive MF or pcALCL compared to that achieved with therapy in the control arm. The key secondary endpoints are complete response (CR), progression-free survival (PFS), and burden of symptoms. Approximately 124 patients will be enrolled in the pivotal trial.
For more information about the trial, please visit www.clinicaltrials.gov.
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.
ADCETRISTM (brentuximab vedotin) received accelerated approval from the US FDA 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 (ALCL) after failure of at least one prior multi-agent chemotherapy regimen. The indications for ADCETRIS are based on response rate. There are no data available demonstrating improvement in patient-reported outcomes or survival with ADCETRIS.
ADCETRIS is not approved for the treatment of CTCL, front-line HL and
front-line ALCL. ADCETRIS is not approved for use outside
About Cutaneous T-Cell Lymphoma
CTCLs constitute a group of non-Hodgkin lymphomas (NHLs) and are cancers of the T lymphocytes (a type of white blood cell) that mainly affect the skin but can also involve the blood, lymph nodes and/or internal organs in patients with advanced disease.
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 future
clinical trials and the risk of adverse events as ADCETRIS advances in
clinical trials. In addition, data from our clinical trials, including
our pivotal trials which were the basis for
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