|View printer-friendly version|
Seattle Genetics Highlights Additional Analyses from ECHELON-1 Phase 3 Clinical Trial of ADCETRIS® (Brentuximab Vedotin) in Newly Diagnosed Advanced Hodgkin Lymphoma at ASH Annual Meeting
December 2, 2018 at 12:00 PM EST
-Data Continue to Show Superior Clinical Activity of ADCETRIS in Combination with AVD when Compared to ABVD in Frontline Advanced Hodgkin Lymphoma-
-Three-Year Progression-Free Survival Data Demonstrate ADCETRIS plus AVD Benefit of 83.1 Percent Compared to 76.0 Percent in ABVD Arm-
-ADCETRIS in Combination with AVD Resulted in Improved Modified Progression-Free Survival Compared to ABVD in Adolescent and Young Adult Hodgkin Lymphoma Patients-
“Prior to the
Three poster presentations highlight analyses from the ECHELON-1 phase 3 clinical trial evaluating ADCETRIS in combination with AVD compared to ABVD (Adriamycin, bleomycin, vinblastine and dacarbazine) in stage III or IV frontline classical HL patients. The ECHELON-1 poster presentations include an analysis of efficacy benefit for ADCETRIS plus AVD regardless of the inclusion of modified events and progression-free survival (PFS) outcomes in patients per investigator, as well as results of the adolescents and young adults (AYA) trial participants. In addition, data will be presented on peripheral neuropathy resolution and improvement for patients treated with ADCETRIS plus AVD or ABVD after 30 months of follow-up.
Brentuximab Vedotin plus Chemotherapy in Patients with Advanced-Stage
Classical Hodgkin Lymphoma: Evaluation of Modified Progression-Free
Survival and Traditional PFS in the Phase 3 ECHELON-1 Study (Abstract
#2904, poster presentation on
As previously reported, the ECHELON-1 trial achieved its primary
endpoint with the combination of ADCETRIS plus AVD resulting in a
statistically significant improvement in modified PFS versus the control
arm of ABVD as assessed by independent review facility (IRF; HR 0.77;
p-value=0.035). Modified PFS was defined as time to progression, death,
or evidence of non-complete response after completion of frontline
therapy per IRF followed by subsequent anticancer therapy. An analysis
was conducted to examine PFS outcomes at three-years and evaluate how
the inclusion of subsequent therapy as modified events affected efficacy
outcomes in the ECHELON-1 study. Key findings will be presented in a
poster presentation by
Brentuximab Vedotin with Chemotherapy in Adolescents and Young Adults
(AYA) with Stage III or IV Hodgkin Lymphoma: a Subgroup Analysis From
the Phase 3 ECHELON-1 Study (Abstract #1647, poster presentation on
Of the 1,334 advanced stage classical HL patients who participated in
the ECHELON-1 clinical trial, 771 patients (57.8 percent) were AYA
defined as age 15 to 39 years, with 396 patients in the ADCETRIS plus
AVD arm and 375 patients in the ABVD control arm. To participate in the
ECHELON-1 study, trial participants had to be 18 years or older. The
median age of patients in the ADCETRIS plus AVD arm compared to the
control arm was 27 years and 28 years, respectively. Key findings were
presented in a poster presentation by
Resolution of Peripheral Neuropathy (PN) in Patients Who Received
A+AVD or ABVD in the Phase 3 ECHELON-1 Trial (Abstract #2921, poster
As previously reported in the ECHELON-1 study, the incidence of
peripheral neuropathy of any grade was 67 percent (442 of 662 patients)
and 43 percent (286 of 659 patients) in the ADCETRIS plus AVD and ABVD
arms of the study, respectively. At the time of primary analysis and
with a median follow-up time of approximately 21 months, 67 percent of
patients treated with ADCETRIS plus AVD had either complete resolution
or improvement of peripheral neuropathy events by at least one grade at
the time of last follow-up. An updated analysis of peripheral neuropathy
outcomes from the ECHELON-1 study at a median follow-up time of 30
months will be presented in a poster presentation by
About ADCETRIS (brentuximab vedotin)
ADCETRIS is being evaluated broadly in more than 70 clinical trials in CD30-expressing lymphomas. These include three recently completed phase 3 trials: ECHELON-2 in frontline peripheral T-cell lymphomas (also known as mature T-cell lymphoma), ECHELON-1 in previously untreated Hodgkin lymphoma, and ALCANZA in cutaneous T-cell lymphoma. The phase 3 CHECKMATE 812 trial of ADCETRIS in combination with Opdivo (nivolumab) for relapsed/refractory Hodgkin lymphoma is ongoing.
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):
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% in any study) Adverse Reactions: Peripheral neuropathy, fatigue, nausea, diarrhea, neutropenia, upper respiratory tract infection, pyrexia, constipation, vomiting, alopecia, decreased weight, abdominal pain, anemia, stomatitis, lymphopenia and mucositis.
Concomitant use of strong CYP3A4 inhibitors or inducers 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.
Seattle Genetics Forward Looking Statements
Certain of the statements made in this press release are forward
looking, such as those, among others, relating to the potential benefit
and use of ADCETRIS (brentuximab vedotin). 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