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Seattle Genetics Announces Multiple Data Presentations Evaluating ADCETRIS® (Brentuximab Vedotin) in Patients with Hodgkin Lymphoma at ISHL 2018
October 26, 2018 at 8:00 AM EDT
-Encore and Additional Analyses from Phase 3 ECHELON-1 Trial Evaluating ADCETRIS in Combination with Chemotherapy in Frontline Advanced HL-
-Interim Results from Ongoing Studies of ADCETRIS plus Opdivo®(Nivolumab) in Frontline or Relapsed Hodgkin Lymphoma-
-Five-Year Results from Phase 3 AETHERA Trial of ADCETRIS as HL Post-Transplant Consolidation Therapy-
“After more than a decade of dedicated clinical research with ADCETRIS,
we have made significant progress in improving the treatment outcomes
for patients with Hodgkin lymphoma,” said
Multiple corporate presentations will be presented at ISHL. Abstracts will be available at www.hodgkinsymposium.org.
Data from four analyses of the phase 3 ECHELON-1 clinical trial will be presented at ISHL. Importantly, an analysis from the ECHELON-1 study (Abstract #0038) will be presented in an oral presentation and poster showing PFS data per investigator that is consistent with the previously reported modified PFS data per Independent Review Facility (IRF). The ECHELON-1 abstracts include the following:
Additional data presentations at ISHL include the following:
Brentuximab Vedotin in Combination with Nivolumab in Patients with
Relapsed or Refractory Hodgkin Lymphoma: Follow-up Results from the
Phase 1/2 Study (Abstract #0005, oral presentation on
Data will be reported from 62 patients with relapsed or refractory HL
who received the combination regimen of ADCETRIS plus Opdivo
after failure of frontline therapy. Patients were treated once every
three weeks, with up to four cycles of combination therapy in the
outpatient setting. After completion of the fourth cycle of treatment,
patients were eligible to undergo an autologous stem cell transplant
(ASCT). The median age of patients was 37 years. The majority of
patients (95 percent) were refractory or had relapsed after receiving
the standard of care frontline treatment ABVD (Adriamycin, bleomycin,
vinblastine and dacarbazine) or some variation of the standard of care
(ABVE-PC, R-ABVD). Key findings will be presented in an oral
Phase 2 Study of Frontline Brentuximab Vedotin Plus Nivolumab in
Patients with Hodgkin Lymphoma Aged ≥60 Years (Abstract #0153, oral
Interim results will be presented from an ongoing phase 2 clinical trial
evaluating ADCETRIS in combination with Opdivo as frontline
therapy for HL patients age 60 years or older. ADCETRIS combination data
were reported from 14 patients. The median age of patients was 71.5
years. The majority of patients (79 percent) had stage III/IV disease at
the time of diagnosis. The interim results will be highlighted in an
oral presentation by
Five-Year Progression-Free Survival Outcomes from a Pivotal Phase 3
Study of Consolidative Brentuximab Vedotin after Autologous Stem-Cell
Transplantation (ASCT) in Patients with Hodgkin Lymphoma at Risk of
Relapse or Progression (AETHERA) (Abstract #0110, oral presentation on
The phase 3 AETHERA clinical trial was designed to evaluate the
potential of single-agent ADCETRIS to extend PFS post-ASCT in patients
with classical HL who were at high risk of relapse or progression.
ADCETRIS was approved by the
About Classical Hodgkin Lymphoma
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. Classical Hodgkin lymphoma is distinguished from other types of lymphoma by the presence of one characteristic type of cell, known as the Reed-Sternberg cell. The Reed-Sternberg cell expresses CD30.
According to the
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 71 countries for relapsed or refractory Hodgkin lymphoma and sALCL. See select important safety information, including Boxed Warning, below.
ADCETRIS (brentuximab vedotin) U.S. Select Important Safety Information
BOXED WARNING: PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY (PML):
JC virus infection resulting in PML and death can occur in ADCETRIS-treated patients.
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.
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
Moderate or severe hepatic impairment or severe renal impairment: MMAE exposure and adverse reactions are increased. Avoid use.
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
utilization of ADCETRIS (brentuximab vedotin) for patients with
previously untreated Stage III or IV classical Hodgkin lymphoma and
other possible uses, and the evaluation of ADCETRIS as a foundation of
therapy for Hodgkin lymphoma. Actual results or developments may differ
materially from those projected or implied in these forward-looking
statements due to factors such as utilization and adoption of the
approved treatment regimen by prescribing physicians, competitive
conditions including the availability of alternative treatment regimens,
the availability and extent of reimbursement, the risk of adverse
events, and adverse regulatory action. More information about the risks
and uncertainties faced by