– Updated Phase 2 data for ADCETRIS in
combination with nivolumab in early and advanced stage classical
Hodgkin lymphoma to be presented in oral session –
– First preclinical data for investigational
antibody-drug conjugate SGN-35C to be presented –
Seagen Inc. (NASDAQ: SGEN) today announced that 12- and 24-month
progression free survival data will be presented for an ADCETRIS®
(brentuximab vedotin) and immunotherapy combination in early and
advanced stage classical Hodgkin lymphoma (cHL), respectively. The
data will be featured in two oral presentations at the 65th
American Society of Hematology (ASH) Annual Meeting &
Exposition, taking place December 9-12, 2023 in San Diego. The
ongoing Phase 2 clinical trial, SGN35-027, is evaluating ADCETRIS
in combination with immunotherapy and chemotherapy.
In addition, pre-clinical data will be presented for a
next-generation novel CD30-directed antibody-drug conjugate (ADC),
SGN-35C, that uses a topoisomerase I inhibitor payload.
“These new data highlight our continued research and development
focus on novel combinations to treat Hodgkin lymphoma and on
next-generation CD30-directed therapies that aim to further improve
outcomes while reducing treatment burden for patients,” said Roger
Dansey, M.D., President, Research and Development and Chief Medical
Officer at Seagen.
ADCETRIS is a proven foundation of care for certain
CD30-expressing lymphomas with more than 120,000 patients treated
globally across seven indications.
Key data for Seagen at ASH include:
Presentations of Company-Sponsored Trials
Abstract Title
Abstract #
Presentation
Lead Author
Brentuximab vedotin
Brentuximab vedotin, nivolumab,
doxorubicin, and dacarbazine for advanced stage classical Hodgkin
lymphoma: efficacy and safety results from the single arm phase 2
study (SGN35-027 Part B)
608
Oral 624
Sunday, Dec. 10
4:45 p.m. PT
Grand Hall B
Lee
Brentuximab vedotin, nivolumab,
doxorubicin, and dacarbazine (AN+AD) for early-stage classical
Hodgkin lymphoma (SGN35-027 Part C)
611
Oral 624
Sunday, Dec. 10
5:30 p.m. PT
Grand Hall B
Abramson
Brentuximab vedotin in frontline therapy
of Hodgkin lymphoma in patients with significant comorbidities
ineligible for standard chemotherapy (SGN35-015 Part E)
4435
Poster
Monday, Dec. 11
6:00 - 8:00 p.m. PT
Halls G-H
Yasenchak
PET4 response as an independent predictor
of long-term outcomes in ECHELON-2 A+CHP vs CHOP in CD30+PTCL
3074
Poster
Sunday, Dec. 10
6:00 - 8:00 p.m. PT
Halls G-H
Iyer
The comparative effectiveness of A+AVD vs
PET-guided ABVD for the management of patients with advanced
Hodgkin lymphoma: a systematic review and matching-adjusted
indirect treatment comparison (Takeda sponsored)
1713
Poster
Saturday, Dec. 9
5:30 - 7:30 p.m. PT
Halls G-H
Kristo
Real-world treatment patterns and patient
outcomes in relapsed/refractory Hodgkin lymphoma in the US (Takeda
sponsored)
-
Abstract only
Kristo
Early-Stage/Pipeline
SGN-35C: a novel CD30-directed
antibody-drug conjugate for the treatment of lymphomas
1440
Poster
Saturday, Dec. 9
5:30 - 7:30 p.m. PT
Halls G-H
Hamblett
Presentations of Investigator and Cooperative Group-Sponsored
Trials
Abstract Title
Abstract #
Presentation
Lead Author
Brentuximab vedotin
Identifying tumor-specific immune response
and biomarkers of high-risk Hodgkin lymphoma patients treated with
and without brentuximab on Children’s Oncology Group trial
AHOD1331
4383
Poster, Monday, Dec.
11
6:00 - 8:00 p.m. PT
Halls G-H
Toner
Longitudinal differences by treatment arm
in health-related quality of life among high risk pediatric
Hodgkin’s lymphoma patients treated on the Children’s Oncology
Group AHOD 1331 study
672
Oral 905
Sunday, Dec. 10
5:54 p.m. PT
Grand Ballroom 2-4
Williams
AHOD2131: a randomized phase 3
response-adapted trial comparing standard therapy with
immuno-oncology therapy for children and adults with newly
diagnosed stage I and II classic Hodgkin lymphoma
3084
Poster
Sunday, Dec. 10
6:00 - 8:00 p.m. PT
Halls G-H
Henderson
Brentuximab vedotin in combination with
nivolumab in CD30+ malignancies refractory to brentuximab
vedotin
3060
Poster
Sunday, Dec. 10
6:00 - 8:00 p.m. PT
Halls G-H
Poh
Reduced dose brentuximab vedotin for
mycosis fungoides appears to prolong response duration by balancing
efficacy and tolerability
1702
Poster Saturday, Dec.
9
5:30 - 7:30 p.m. PT
Halls G-H
Munayirji
Final results of a multicenter pilot study
evaluating brentuximab vedotin with cyclophosphamide, doxorubicin,
etoposide, and prednisone (BV-CHEP) for the treatment of aggressive
adult T-cell leukemia/lymphoma
1692
Poster
Saturday, Dec. 9
5:30 - 7:30 p.m. PT
Halls G-H
Dittus
Immune landscape associated with response
to brentuximab vedotin with ipilimumab and/or nivolumab in
relapsed/refractory Hodgkin lymphoma (E4412 phase 1)
4382
Poster
Monday, Dec. 11
6:00 - 8:00 p.m. PT
Halls G-H
Gonzalez-Kozlova
CNS involvement in pediatric Hodgkin
lymphoma: a comprehensive retrospective analysis from the SEARCH
for CAYAHL group
3066
Poster
Sunday, Dec. 10
6:00 - 8:00 p.m.
PT
Halls G-H
Pabari
Comprehensive analysis of treatment
related morbidity and progression-free survival in the GHSG phase
III HD21 trial
3057
Poster
Sunday, Dec. 10
6:00 - 8:00 p.m. PT
Halls G-H
Borchmann
Pregnancies and childbirth following
advanced-stage HL treatment with BrECADD or BEACOPP in the
randomized phase III GHSG HD21 trial
4437
Poster
Monday, Dec. 11 6:00-8:00
p.m.
Halls G-H
Ferdinandus
About ADCETRIS
ADCETRIS is an antibody-drug conjugate (ADC) comprised of a
CD30-directed monoclonal antibody attached by a protease-cleavable
linker to a microtubule disrupting agent, monomethyl auristatin E
(MMAE), utilizing Seagen's 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-positive tumor
cells.
ADCETRIS is approved in seven indications in the U.S.:
- Adult patients with previously untreated Stage III/IV cHL in
combination with doxorubicin, vinblastine, and dacarbazine
(2018)
- Pediatric patients 2 years and older with previously untreated
high risk cHL in combination with doxorubicin, vincristine,
etoposide, prednisone and cyclophosphamide (2022)
- Adult patients with cHL at high risk of relapse or progression
as post-autologous hematopoietic stem cell transplantation
(auto-HSCT) consolidation (2015)
- Adult patients with cHL after failure of auto-HSCT or after
failure of at least two prior multi-agent chemotherapy regimens in
patients who are not auto-HSCT candidates (2011)
- Adult patients with previously untreated systemic anaplastic
large cell lymphoma (sALCL) or other CD30-expressing peripheral
T-cell lymphomas (PTCL), including angioimmunoblastic T-cell
lymphoma and PTCL not otherwise specified, in combination with
cyclophosphamide, doxorubicin, and prednisone (2018)
- Adult patients with sALCL after failure of at least one prior
multi-agent chemotherapy regimen (2011)
- Adult patients with primary cutaneous anaplastic large cell
lymphoma (pcALCL) or CD30-expressing mycosis fungoides (MF) after
prior systemic therapy (2017)
ADCETRIS has marketing authorization in more than 70 countries
for relapsed or refractory Hodgkin lymphoma and systemic anaplastic
large cell lymphoma.
Seagen and Takeda jointly develop ADCETRIS. Under the terms of
the collaboration agreement, Seagen has U.S. and Canadian
commercialization rights, and Takeda has rights to commercialize
ADCETRIS in the rest of the world. Seagen and Takeda are funding
joint development costs for ADCETRIS on a 50:50 basis, except in
Japan where Takeda is solely responsible for development costs.
ADCETRIS® (brentuximab vedotin) for injection U.S. Important
Safety Information
BOXED WARNING
PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY (PML): JC virus
infection resulting in PML and death can occur in ADCETRIS-treated
patients.
CONTRAINDICATION
Contraindicated with concomitant bleomycin due to pulmonary
toxicity (e.g., interstitial infiltration and/or inflammation).
WARNINGS AND PRECAUTIONS
Peripheral neuropathy (PN): ADCETRIS causes PN that is
predominantly sensory. Cases of motor PN have also been reported.
ADCETRIS-induced PN is cumulative. Monitor for symptoms such as
hypoesthesia, hyperesthesia, paresthesia, discomfort, a burning
sensation, neuropathic pain, or weakness. Patients experiencing new
or worsening PN may require a delay, change in dose, or
discontinuation of ADCETRIS.
Anaphylaxis and infusion reactions: Infusion-related
reactions (IRR), including anaphylaxis, have occurred with
ADCETRIS. Monitor patients during infusion. If an IRR occurs,
interrupt the infusion and institute appropriate medical
management. If anaphylaxis occurs, immediately and permanently
discontinue the infusion and administer appropriate medical
therapy. Premedicate patients with a prior IRR before subsequent
infusions. Premedication may include acetaminophen, an
antihistamine, and a corticosteroid.
Hematologic toxicities: Fatal and serious cases of
febrile neutropenia have been reported with ADCETRIS. Prolonged (≥1
week) severe neutropenia and Grade 3 or 4 thrombocytopenia or
anemia can occur with ADCETRIS.
Administer G-CSF primary prophylaxis beginning with Cycle 1 for
adult patients who receive ADCETRIS in combination with
chemotherapy for previously untreated Stage III/IV cHL or
previously untreated PTCL, and pediatric patients who receive
ADCETRIS in combination with chemotherapy for previously untreated
high risk cHL.
Monitor complete blood counts prior to each ADCETRIS dose.
Monitor more frequently for patients with Grade 3 or 4 neutropenia.
Monitor patients for fever. If Grade 3 or 4 neutropenia develops,
consider dose delays, reductions, discontinuation, or G-CSF
prophylaxis with subsequent doses.
Serious infections and opportunistic infections:
Infections such as pneumonia, bacteremia, and sepsis or septic
shock (including fatal outcomes) have been reported in
ADCETRIS-treated patients. Closely monitor patients during
treatment for infections.
Tumor lysis syndrome: Patients with rapidly proliferating
tumor and high tumor burden may be at increased risk. Monitor
closely and take appropriate measures.
Increased toxicity in the presence of severe renal
impairment: The frequency of ≥Grade 3 adverse reactions and
deaths was greater in patients with severe renal impairment. Avoid
use in patients with severe renal impairment.
Increased toxicity in the presence of moderate or severe
hepatic impairment: The frequency of ≥Grade 3 adverse reactions
and deaths was greater in patients with moderate or severe hepatic
impairment. Avoid use in patients with moderate or severe hepatic
impairment.
Hepatotoxicity: Fatal and serious cases have occurred in
ADCETRIS-treated patients. Cases were consistent with
hepatocellular injury, including elevations of transaminases and/or
bilirubin, and occurred after the first ADCETRIS dose or
rechallenge. Preexisting liver disease, elevated baseline liver
enzymes, and concomitant medications may increase the risk. Monitor
liver enzymes and bilirubin. Patients with new, worsening, or
recurrent hepatotoxicity may require a delay, change in dose, or
discontinuation of ADCETRIS.
PML: Fatal cases of JC virus infection resulting in PML
have been reported in ADCETRIS-treated patients. First onset of
symptoms occurred at various times from initiation of ADCETRIS,
with some cases occurring within 3 months of initial exposure. In
addition to ADCETRIS therapy, other possible contributory factors
include prior therapies and underlying disease that may cause
immunosuppression. Consider PML diagnosis in patients with
new-onset signs and symptoms of central nervous system
abnormalities. Hold ADCETRIS if PML is suspected and discontinue
ADCETRIS if PML is confirmed.
Pulmonary toxicity: Fatal and serious events of
noninfectious pulmonary toxicity, including pneumonitis,
interstitial lung disease, and acute respiratory distress syndrome,
have been reported. Monitor patients for signs and symptoms,
including cough and dyspnea. In the event of new or worsening
pulmonary symptoms, hold ADCETRIS dosing during evaluation and
until symptomatic improvement.
Serious dermatologic reactions: Fatal and serious cases
of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis
(TEN) have been reported with ADCETRIS. If SJS or TEN occurs,
discontinue ADCETRIS and administer appropriate medical
therapy.
Gastrointestinal (GI) complications: Fatal and serious
cases of acute pancreatitis have been reported. Other fatal and
serious GI complications include perforation, hemorrhage, erosion,
ulcer, intestinal obstruction, enterocolitis, neutropenic colitis,
and ileus. Lymphoma with preexisting GI involvement may increase
the risk of perforation. In the event of new or worsening GI
symptoms, including severe abdominal pain, perform a prompt
diagnostic evaluation and treat appropriately.
Hyperglycemia: Serious cases, such as new-onset
hyperglycemia, exacerbation of preexisting diabetes mellitus, and
ketoacidosis (including fatal outcomes) have been reported with
ADCETRIS. Hyperglycemia occurred more frequently in patients with
high body mass index or diabetes. Monitor serum glucose and if
hyperglycemia develops, administer anti-hyperglycemic medications
as clinically indicated.
Embryo-fetal toxicity: Based on the mechanism of action
and animal studies, ADCETRIS can cause fetal harm. Advise females
of reproductive potential of this potential risk, and to use
effective contraception during ADCETRIS treatment and for 2 months
after the last dose of ADCETRIS. Advise male patients with female
partners of reproductive potential to use effective contraception
during ADCETRIS treatment and for 4 months after the last dose of
ADCETRIS.
ADVERSE REACTIONS
The most common adverse reactions (≥20% in any study) are
peripheral neuropathy, fatigue, nausea, diarrhea, neutropenia,
upper respiratory tract infection, pyrexia, constipation, vomiting,
alopecia, decreased weight, abdominal pain, anemia, stomatitis,
lymphopenia, mucositis, thrombocytopenia, and febrile
neutropenia.
DRUG INTERACTIONS
Concomitant use of strong CYP3A4 inhibitors has the potential to
affect the exposure to monomethyl auristatin E (MMAE). Closely
monitor adverse reactions.
USE IN SPECIAL POPULATIONS
Lactation: Breastfeeding is not recommended during
ADCETRIS treatment.
Please see the full Prescribing Information, including BOXED
WARNING, for ADCETRIS here.
About Seagen
Founded 25 years ago, Seagen Inc. is a global biotechnology
company that discovers, develops, manufactures and commercializes
targeted cancer therapeutics, with antibody-drug conjugates (ADCs)
at our core. Our colleagues work together with urgency to improve
and extend the lives of people living with cancer. An ADC
technology trailblazer, approximately one-third of FDA-approved and
marketed ADCs use Seagen technology. Seagen is headquartered in
Bothell, Washington and has locations in California, Canada,
Switzerland and across Europe. For additional information, visit
seagen.com and follow us on X and LinkedIn.
Forward-Looking Statements
Certain statements made in this press release are forward
looking, such as those, among others, relating to the therapeutic
potential of ADCETRIS and SGN-35C; their potential safety, efficacy
and therapeutic uses; and Seagen’s pipeline. Actual results or
developments may differ materially from those projected or implied
in these forward-looking statements. Factors that may cause such a
difference include, without limitation, the risk of delays,
setbacks or failures in product development activities, even after
encouraging results in earlier-stage trials, for a variety of
reasons, including without limitation the difficulty and
uncertainty of pharmaceutical product development, the possibility
that clinical results may not support continued development or
regulatory approvals, the risk of adverse events or safety signals,
and the possibility of adverse regulatory actions. More information
about the risks and uncertainties faced by Seagen is contained
under the caption “Risk Factors” included in Seagen’s Quarterly
Report on Form 10-Q for the quarter ended September 30, 2023, and
Seagen’s subsequent reports, filed with the Securities and Exchange
Commission. Seagen disclaims any intention or obligation to update
or revise any forward-looking statements, whether as a result of
new information, future events or otherwise except as required by
applicable law.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20231101325203/en/
For Media David Caouette (310) 430-3476 dcaouette@seagen.com
For Investors Douglas Maffei, Ph.D. (425) 527-4160
dmaffei@seagen.com
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