|Seattle Genetics Highlights Additional Analyses from Phase 3 ECHELON-1 Clinical Trial of ADCETRIS® (Brentuximab Vedotin) in Newly Diagnosed Advanced Hodgkin Lymphoma at 2018 ASCO Annual Meeting|
Data Continue to Support Superior Clinical Activity of ADCETRIS in Combination with Chemotherapy when Compared to ABVD in Frontline Advanced Hodgkin Lymphoma
Results from Patients Treated in North America Demonstrate Two-Year Modified Progression-Free Survival of 84.3 Percent in the ADCETRIS Combination Arm Compared to 73.7 Percent in the ABVD Arm
Positive ECHELON-1 Results Supported FDA Approval of ADCETRIS in Combination with Chemotherapy for Adults with Previously Untreated Stage III or IV Classical Hodgkin Lymphoma
“For over 40 years, the standard of care for the treatment of frontline
“Our goal is to establish ADCETRIS as the foundation of care for
CD30-expressing lymphomas, including HL, and the data presented at
Three poster presentations highlight analyses from the ECHELON-1 phase 3 clinical trial evaluating ADCETRIS in combination with AVD (Adriamycin®, vinblastine and dacarbazine) compared to ABVD (Adriamycin, bleomycin, vinblastine and dacarbazine) in stage III or IV frontline classical HL patients. The ECHELON-1 poster presentations include the results of the North American patient population, optimizing therapy with the use of primary prophylactic growth factors (G-CSF) and improvement of modified progression-free survival (PFS) outcomes in patients who received ADCETRIS plus AVD regardless of cycle 2 PET (PET2) status. In addition, long-term follow-up from an ongoing phase 2 clinical trial in newly diagnosed older HL patients was reported.
Brentuximab Vedotin plus Chemotherapy in Patients with Newly
Diagnosed Advanced Stage Hodgkin Lymphoma: North American Results
(Abstract #7541, poster presentation on
Of the 1,334 advanced stage classical HL patients who participated in
the ECHELON-1 clinical trial, 497 patients were treated in
Improving Outcomes with Brentuximab Vedotin plus Chemotherapy in
Patients with Newly Diagnosed Advanced Stage Hodgkin Lymphoma (Abstract
#7534, poster presentation on
During the ECHELON-1 clinical trial, an independent monitoring committee
(IDMC) recommended the use of primary prophylactic G-CSF for patients in
the ADCETRIS plus AVD arm of the study due to an increased risk of
febrile neutropenia. In the ADCETRIS plus AVD arm, 83 patients received
G-CSF primary prophylaxis (defined as receipt of G-CSF by day five of
the first treatment cycle) and 579 patients did not. An analysis of
these two patient populations in the ECHELON-1 study presented by Dr.
Brentuximab Vedotin with Chemotherapy for Stage III or IV Hodgkin
Lymphoma: Impact of Cycle 2 PET Result on Modified Progression-Free
Survival (Abstract #7539, poster presentation on
A post-hoc analysis of the ECHELON-1 clinical trial was conducted to
evaluate modified PFS outcomes and clinical characteristics by PET2
status per IRF. In the ADCETRIS plus AVD arm of the study, 588 patients
were PET2-negative (Deauville score ≤3) and 47 were PET2-positive
(Deauville score ≥4). In the ABVD arm of the study, 577 patients were
PET2-negative and 58 were PET2-positive. The analysis presented by Dr.
Long-Term Follow-Up of Brentuximab Vedotin +/- Dacarbazine as
First-Line Therapy in Elderly Patients with Hodgkin Lymphoma (Abstract
#7542, poster presentation on
Long-term follow-up results were presented from an ongoing phase 2
clinical trial evaluating ADCETRIS alone or in combination with
dacarbazine as frontline therapy for HL patients age 60 years or older.
Data were reported from 27 patients treated with ADCETRIS monotherapy
and 22 patients treated with ADCETRIS in combination with dacarbazine.
The median age of patients was 78 years in the ADCETRIS monotherapy arm
and 69 years in the dacarbazine combination arm. Over 60 percent of
patients in each arm had stage III/IV disease at the time of diagnosis
and the majority were frail with multiple comorbidities. Long-term data
highlighted by Dr.
ADCETRIS in combination with dacarbazine is not approved for use in frontline HL.
ECHELON-1 is a randomized, open-label, two-arm, multi-center phase 3 study designed to compare ADCETRIS plus (Adriamycin, vinblastine and dacarbazine) to ABVD (Adriamycin, bleomycin, vinblastine and dacarbazine) as frontline therapy in patients with previously untreated advanced classical HL. The primary endpoint is modified progression-free survival (PFS) per Independent Review Facility (IRF). Modified PFS is defined as time to progression, death, or evidence of non-complete response after completion of frontline therapy per IRF followed by subsequent anticancer therapy. The study enrolled 1,334 patients who had histologically-confirmed diagnosis of Stage III or IV Hodgkin lymphoma and had not been previously treated with systemic chemotherapy or radiotherapy.
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, including two ongoing phase 3 studies: the ECHELON-2 trial in frontline mature T-cell lymphomas (also known as peripheral T-cell lymphoma) and the 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.
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. 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