|Seattle Genetics Highlights ADCETRIS® (Brentuximab Vedotin) Data in CD30-Positive Non-Hodgkin Lymphomas and Other Malignancies from Multiple Presentations at ASH Annual Meeting|
-34 Percent Objective Response Rate in Phase II Trial for Relapsed or Refractory Non-Hodgkin Lymphomas, Including 44 Percent in Diffuse Large B-cell Lymphoma (DLBCL)-
-Long-term Follow-up Demonstrates Durable Complete Remissions in Pivotal Systemic ALCL Trial-
-Investigator Data Describe CD30 Expression in up to 25 Percent of DLBCL Cases-
-Case Studies Indicate Activity of ADCETRIS in Systemic Mastocytosis-
“This collection of data from both corporate studies as well as
investigator research into CD30 and the clinical role of ADCETRIS in
non-Hodgkin lymphomas add to a growing body of evidence that ADCETRIS
has potential in a broad array of CD30-positive malignancies,” said
A Phase II Study of Brentuximab Vedotin in Patients with Relapsed or Refractory CD30-Positive Non-Hodgkin Lymphomas (Abstract #2746)
In an ongoing phase II clinical trial, patients with relapsed or refractory CD30-positive non-Hodgkin lymphomas have been enrolled, including DLBCL and several other non-Hodgkin lymphoma subtypes. The trial is designed to assess the antitumor activity, duration of response and safety profile of ADCETRIS in these patients. At the time of data analysis, 73 patients had been enrolled, including 44 with B-cell lymphoma and 29 with T-cell lymphoma. The median number of prior systemic therapies in both lymphoma classifications was two. Key findings include:
ADCETRIS is not approved for the treatment of the non-Hodgkin lymphoma subtypes described in this presentation.
Long-term Remissions Observed in an Ongoing Phase II Study of Brentuximab Vedotin in Patients with Relapsed or Refractory Systemic Anaplastic Large Cell Lymphoma (Abstract #2745)
A pivotal, single-arm clinical trial was conducted in 58 relapsed or refractory sALCL patients to assess efficacy and safety of single-agent ADCETRIS. In addition, the trial was designed to determine duration of response, progression-free survival and overall survival. Enrolled patients had received a median of two prior chemotherapy regimens.
Data highlights from long-term patient follow up in the pivotal trial were:
CD30 Expression in Diffuse Large B-Cell Lymphoma (Abstract #1558) and CD30 Expression in DLBCL and Its Relation to Important Clinical and Biological Disease Features (Abstract #1592)
In two investigator-led abstracts, data described the outcome of research into CD30 expression in DLBCL patient samples. In one presentation, data indicated that 24.7 percent of DLBCL cases expressed CD30 by immunohistochemistry (95 of 385 samples). In a separate analysis, 23 percent of DLBCL cases expressed CD30 by immunohistochemistry (34 of 148 samples). Both investigators concluded that clinical evaluation of ADCETRIS in DLBCL is warranted.
These findings support Seattle Genetics’ ongoing evaluation of ADCETRIS as a treatment for DLBCL. A phase II trial for non-Hodgkin lymphoma, including DLBCL, is currently enrolling patients.
ADCETRIS is not approved for the treatment of the DLBCL.
Anti-CD30 Antibody-Drug Conjugate Brentuximab Vedotin May Be a Promising Treatment Option for Systemic Mastocytosis (SM) (Abstract #2857)
Systemic mastocytosis is a clonal proliferation of abnormal mast cells leading to clinical syndromes including aggressive systemic mastocytosis (ASM) and mast cell leukemia. ASM has been shown to express CD30. In this presentation, data describe the outcome of two patients with ASM who had significant clinical benefit from treatment with ADCETRIS. Both patients had a decrease in mast cell bone marrow percentage involvement and density (including one partial remission), as well as improved normal hematopoiesis. The investigator noted that treatment with ADCETRIS was well-tolerated in these patients. ADCETRIS dose level was reduced for one patient due to peripheral neuropathy and neutropenia.
ADCETRIS is not approved for the treatment of the systemic mastocytosis.
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 was granted conditional marketing authorization by 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 the
featured 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