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Seattle Genetics Announces Multiple ADCETRIS® (Brentuximab Vedotin) Data Presentations at the International Conference on Malignant Lymphoma
June 17, 2015 at 9:00 AM EDT
-Additional Analysis of Phase 3 AETHERA Data Demonstrates ADCETRIS Consolidation Therapy Significantly Extends Progression-Free Survival in Primary-Refractory Hodgkin Lymphoma Patients-
“Since the initial
Analysis of primary-refractory Hodgkin lymphoma patients in a
randomized, placebo-controlled study of brentuximab vedotin
consolidation after autologous stem cell transplant (
Data were reported from an additional analysis of the phase 3 AETHERA clinical trial evaluating PFS by investigator in patients who were refractory to frontline treatment. Previously published data suggest primary-refractory HL patients have poor outcomes following ASCT, as demonstrated by the historical two-year PFS and three-year overall survival rates of less than 40 percent and 50 percent, respectively. Of the 329 patients enrolled in the AETHERA trial, 60 percent (196 patients) were primary-refractory to frontline treatment.
Results of the analysis demonstrated:
Additional AETHERA data were included in a poster presentation reporting the frequency of healthcare resource utilization (HRU) among patients on the two treatment arms of the trial. Preliminary reports suggest a trend toward lower HRU in patients treated with ADCETRIS compared with placebo.
ADCETRIS is currently not approved for use in the AETHERA treatment
setting. Based on the positive results from the AETHERA trial, a
supplemental Biologics License Application (BLA) for ADCETRIS in the
post-ASCT consolidation treatment of HL patients at high risk of relapse
or progression was accepted for filing by the
Additional ADCETRIS corporate and investigator presentations are included below and full abstracts can be found in the ICML Educational and Abstract Book accessed on the ICML website at www.lymphcon.ch.
ADCETRIS is not currently approved for use in frontline HL, in combination with bendamustine for relapsed or refractory HL and sALCL, or in DLBCL.
ADCETRIS is being evaluated broadly in more than 30 ongoing clinical trials, including four phase 3 studies, in earlier lines of its approved HL and sALCL indications as well as in many additional types of CD30-positive malignancies, including cutaneous T-cell lymphoma, B-cell lymphomas and mature T-cell lymphomas.
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 for intravenous injection received accelerated approval from
ADCETRIS was granted conditional marketing authorization by the
ADCETRIS (brentuximab vedotin) U.S. Important Safety Information
Progressive multifocal leukoencephalopathy (PML): JC virus infection resulting in PML and death can occur in patients receiving ADCETRIS.
ADCETRIS is contraindicated with concomitant bleomycin due to pulmonary toxicity (e.g., interstitial infiltration and/or inflammation).
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.
Concomitant use of strong CYP3A4 inhibitors or inducers, or P-gp inhibitors, has the potential to affect the exposure to monomethyl auristatin E (MMAE).
Use in Specific Populations:
MMAE exposure and adverse reactions are increased in patients with moderate or severe hepatic impairment or severe renal impairment. Avoid use.
For additional Important Safety Information, including Boxed WARNING, please see the full Prescribing Information for ADCETRIS at www.seattlegenetics.com.
Certain of the statements made in this press release are forward
looking, such as those, among others, relating to the potential approval