-Enrollment Continues on Phase 3 CASCADE Trial in Acute Myeloid
Leukemia and Phase 1/2 Trial in Myelodysplastic Syndrome-
BOTHELL, Wash.--(BUSINESS WIRE)--Dec. 27, 2016--
Genetics, Inc. (Nasdaq:SGEN), a global biotechnology company, today
announced that it has received notice from the U.S. Food and Drug
Administration (FDA) that a clinical hold or partial clinical hold has
been placed on several early stage trials of vadastuximab talirine
(SGN-CD33A) in acute myeloid leukemia (AML). The clinical holds were
initiated to evaluate the potential risk of hepatotoxicity in patients
who were treated with SGN-CD33A and received allogeneic stem cell
transplant either before or after treatment. Six patients have been
identified with hepatotoxicity, including several cases of
veno-occlusive disease, with four fatal events. Overall, more than 300
patients have been treated with SGN-CD33A in clinical trials across
multiple treatment settings. Seattle Genetics is working diligently with
the FDA to determine whether there is any association between
hepatotoxicity and treatment with SGN-CD33A, to promptly identify
appropriate protocol amendments for patient safety and to enable
continuation of these trials.
The phase 1/2 trial of SGN-CD33A monotherapy in pre- and post-allogeneic
transplant AML patients has been placed on full clinical hold. Two phase
1 trials have been placed on partial clinical hold (no new enrollment,
existing patients may continue treatment with re-consent). These studies
are SGN-CD33A monotherapy, including a subset of older AML patients in
combination with hypomethylating agents, and SGN-CD33A combination
treatment with 7+3 chemotherapy in newly diagnosed younger AML patients.
No new studies will be initiated until the clinical holds are lifted.
Seattle Genetics’ other ongoing trials of SGN-CD33A, including the phase
3 CASCADE trial in older AML patients and phase 1/2 trial in
myelodysplastic syndrome, are proceeding with enrollment.
About Vadastuximab Talirine (SGN-CD33A)
Vadastuximab talirine (SGN-CD33A; 33A) is a novel investigational ADC
targeted to CD33 utilizing Seattle Genetics’ proprietary ADC technology.
CD33 is expressed on most AML and MDS blast cells. The CD33 engineered
cysteine antibody is stably linked to a highly potent DNA binding agent
called a pyrrolobenzodiazepine (PBD) dimer via site-specific conjugation
technology (EC-mAb). PBD dimers are significantly more potent than
systemic chemotherapeutic drugs and the EC-mAb technology allows uniform
drug-loading onto an ADC. The ADC is designed to be stable in the
bloodstream and to release its potent cell-killing PBD agent upon
internalization into CD33-expressing cells.
33A was granted Orphan Drug Designation by both the U.S. Food and Drug
Administration (FDA) and the European Commission for the treatment of
AML. FDA orphan drug designation is intended to encourage companies to
develop therapies for the treatment of diseases that affect fewer than
200,000 individuals in the United States.
About Seattle Genetics
Seattle Genetics is an innovative biotechnology company that develops
and commercializes novel antibody-based therapies for the treatment of
cancer. The company’s industry-leading antibody-drug conjugate (ADC)
technology harnesses the targeting ability of antibodies to deliver
cell-killing agents directly to cancer cells. ADCETRIS® (brentuximab
vedotin), the company’s lead product, in collaboration with Takeda
Pharmaceutical Company Limited, is the first in a new class of ADCs
commercially available globally in 65 countries for relapsed classical
Hodgkin lymphoma (HL) and relapsed systemic anaplastic large cell
lymphoma (sALCL). Seattle Genetics is also advancing vadastuximab
talirine (SGN-CD33A; 33A), an ADC in a phase 3 trial for acute myeloid
leukemia. Headquartered in Bothell, Washington, Seattle Genetics has a
robust pipeline of innovative therapies for blood-related cancers and
solid tumors designed to address significant unmet medical needs and
improve treatment outcomes for patients. The company has collaborations
for its proprietary ADC technology with a number of companies including
AbbVie, Astellas, Bayer, Celldex, Genentech, GlaxoSmithKline and Pfizer.
More information can be found at www.seattlegenetics.com
Forward Looking Statements
Certain of the statements made in this press release are forward
looking, such as those, among others, relating to the potential that the
full and partial clinical holds on the affected clinical trials for
SGN-33A will be lifted so that these trials may continue and the
possibility that SGN-CD33A may be approved for treatment of AML. 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 the inability to provide information and institute
safety mitigation measures as required by the FDA to permit these trials
to continue in which case these trials may be delayed or discontinued.
More information about the risks and uncertainties faced by Seattle
Genetics is contained under the caption “Risk Factors” included in the
company’s Quarterly Report on Form 10-Q for the quarter ended September
30, 2016 filed with the Securities and Exchange Commission. Seattle
Genetics disclaims any intention or obligation to update or revise any
forward-looking statements, whether as a result of new information,
future events or otherwise.
View source version on businesswire.com: http://www.businesswire.com/news/home/20161227005087/en/
Source: Seattle Genetics, Inc.
Seattle Genetics, Inc.
Peggy Pinkston, 425-527-4160