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Seattle Genetics Submits Supplemental Biologics License Application for ADCETRIS® (Brentuximab Vedotin) in Frontline Treatment of CD30-Expressing Peripheral T-Cell Lymphomas
November 5, 2018 at 8:00 AM EST
-Submission Based on Positive Phase 3 ECHELON-2 Trial Evaluating ADCETRIS in Frontline CD30-Expressing Peripheral T-Cell Lymphoma-
-ECHELON-2 Data will be Presented at
“CD30 is expressed in several subtypes of peripheral T-cell lymphoma, an
aggressive type of non-Hodgkin lymphoma, and the current standard of
care for frontline treatment consisting of a multi-agent chemotherapy
regimen called CHOP has not changed in several decades,” said
The phase 3 ECHELON-2 clinical trial evaluated the combination of ADCETRIS plus CHP (cyclophosphamide, doxorubicin, prednisone) compared to a recognized standard of care chemotherapy regimen, CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone), in previously untreated CD30-expressing PTCL. The ECHELON-2 study met its primary endpoint demonstrating a statistically significant improvement in progression-free survival (PFS) as assessed by an Independent Review Facility (IRF; hazard ratio=0.71; p-value=0.0110). The ADCETRIS plus CHP arm also demonstrated superior overall survival (OS), a key secondary endpoint, compared to CHOP (hazard ratio=0.66; p-value=0.0244). All other key secondary endpoints, including PFS in patients with systemic anaplastic large cell lymphoma (sALCL), complete remission rate and objective response rate were statistically significant in favor of the ADCETRIS plus CHP arm. The safety profile of ADCETRIS plus CHP in the ECHELON-2 trial was comparable to CHOP and consistent with the established safety profile of ADCETRIS in combination with chemotherapy. Full data will be presented at the ASH Annual Meeting in the following session:
ECHELON-2 Phase 3 Clinical Trial Design
The randomized, double-blind, placebo-controlled phase 3 trial is
investigating ADCETRIS plus CHP (cyclophosphamide, doxorubicin,
prednisone) versus CHOP (cyclophosphamide, doxorubicin, vincristine,
prednisone) as frontline therapy in patients with CD30-expressing
peripheral T-cell lymphoma, also known as mature T-cell lymphoma. The
primary endpoint is progression-free survival (PFS) per Independent
Review Facility assessment, with events defined as progression, death,
or receipt of chemotherapy for residual or progressive disease.
Secondary endpoints include PFS in patients with systemic anaplastic
large cell lymphoma (sALCL), complete remission rate, overall survival
and objective response rate, in addition to safety. The multi-center
trial was conducted at sites across
Please see Important Safety Information at the end of this press release.
About T-Cell Lymphomas
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. There are more than 60 subtypes of
non-Hodgkin lymphomas which are broadly divided into two major groups:
B-cell lymphomas, which develop from abnormal B-lymphocytes, and T-cell
lymphomas, which develop from abnormal T-lymphocytes. There are many
different forms of T-cell lymphomas, some of which are extremely rare.
T-cell lymphomas can be aggressive (fast-growing) or indolent
(slow-growing). PTCL accounts for approximately 10 percent of
non-Hodgkin lymphoma cases in the U.S. and
About ADCETRIS (brentuximab vedotin)
ADCETRIS is being evaluated broadly in more than 70 clinical trials in CD30-expressing lymphomas. These include the recently completed phase 3 ECHELON-2 trial in frontline peripheral T-cell lymphomas (also known as mature T-cell lymphoma), the completed phase 3 ECHELON-1 trial in previously untreated Hodgkin lymphoma, the completed phase 3 ALCANZA trial in cutaneous T-cell lymphoma, and the ongoing CHECKMATE 812 trial of ADCETRIS in combination with Opdivo (nivolumab) for relapsed/refractory Hodgkin lymphoma.
ADCETRIS 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 injection for intravenous infusion has received
ADCETRIS received conditional marketing authorization from the
ADCETRIS has received marketing authorization by regulatory authorities in 72 countries for relapsed or refractory Hodgkin lymphoma and sALCL. See select important safety information, including Boxed Warning, below.
ADCETRIS (brentuximab vedotin) Important Safety Information
BOXED WARNING: PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY (PML):
ADCETRIS concomitant with bleomycin due to pulmonary toxicity (e.g., interstitial infiltration and/or inflammation).
Warnings and Precautions
Most Common (≥20%) Adverse Reactions: Neutropenia, anemia,peripheral sensory neuropathy, nausea, fatigue, constipation, diarrhea, vomiting, and pyrexia.
Use in Specific Populations
Advise males with female sexual partners of reproductive potential to use effective contraception during ADCETRIS treatment and for at least 6 months after the final dose of ADCETRIS.
Advise patients to report pregnancy immediately and avoid breastfeeding while receiving ADCETRIS.
Forward Looking Statements
Certain of the statements made in this press release are forward
looking, such as those, among others, relating to the potential