Seattle Genetics Discontinues Phase 3 CASCADE Trial of Vadastuximab Talirine (SGN-CD33A) in Frontline Acute Myeloid Leukemia
June 19 2017 - 6:45AM
Business Wire
Seattle Genetics, Inc. (Nasdaq: SGEN), a global biotechnology
company, today announced that it is discontinuing the phase 3
CASCADE clinical trial of vadastuximab talirine (SGN-CD33A) in
frontline older acute myeloid leukemia (AML) patients. Seattle
Genetics took this action following consultation with the
Independent Data Monitoring Committee (IDMC) and after reviewing
unblinded data on June 16, 2017. The data indicated a higher rate
of deaths, including fatal infections in the vadastuximab
talirine-containing arm versus the control arm of the trial. Based
on available data, the safety concerns in this trial do not appear
related to hepatotoxicity. Seattle Genetics is suspending patient
enrollment and treatment in all of its vadastuximab talirine
clinical trials including the ongoing phase 1/2 clinical trial in
frontline high risk myelodysplastic syndrome (MDS). Seattle
Genetics will closely review the data and consult with the U.S.
Food and Drug Administration (FDA) to determine future plans for
the vadastuximab talirine development program.
“This is a disappointing and unexpected result for the CASCADE
trial. Patient safety is our highest priority, and we will closely
review the data and evaluate next steps. AML is a devastating
disease with a poor prognosis in most patients, and there is a
great need for therapeutics against this disease. We thank the
patients, caregivers and investigators for their support of this
trial,” said Clay Siegall, Ph.D., President and Chief Executive
Officer at Seattle Genetics. “We are enthusiastic about the many
opportunities across our broad pipeline, including ADCETRIS®
(brentuximab vedotin), enfortumab vedotin (ASG-22ME) and SGN-LIV1A.
Notably, we are looking forward to reporting data from our ADCETRIS
phase 3 ECHELON-1 trial in frontline Hodgkin lymphoma, and we are
on track to advance enfortumab vedotin into a pivotal trial in
metastatic urothelial cancer in the second half of 2017 under our
collaboration with Astellas.”
The phase 3 CASCADE clinical trial is a randomized,
double-blind, placebo-controlled study evaluating vadastuximab
talirine in combination with the hypomethylating agents (HMAs)
azacitidine or decitabine compared to an HMA alone in older
patients with newly diagnosed AML. Vadastuximab talirine is a novel
investigational ADC targeted to CD33 utilizing Seattle Genetics’
proprietary ADC technology. CD33 is expressed on most AML and MDS
blast cells.
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 and is commercially available globally
in 67 countries for relapsed classical Hodgkin lymphoma (HL) and
relapsed systemic anaplastic large cell lymphoma (sALCL). Seattle
Genetics is also advancing enfortumab vedotin, an ADC for
metastatic urothelial cancer, in a planned pivotal trial in
collaboration with Astellas. Headquartered in Bothell, Washington
and with European and international operations in Zug, Switzerland,
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 Seattle Genetics’
future actions and plans with respect to its vadastuximab talirine
(SGN-CD33A) development program, Seattle Genetics’ expectations
with respect to the opportunities related to the remainder of its
pipeline, Seattle Genetics’ expectations for future ADCETRIS and
enfortumab vedotin clinical trial events and the timing thereof,
and other statements that are not historical facts. 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 possibility that the safety profile
of vadastuximab talirine may not support further development of the
drug candidate or of adverse regulatory action, and the possibility
that Seattle Genetics may determine to discontinue its vadastuximab
talirine development program. Seattle Genetics may also be delayed
in its planned clinical trial initiations, the enrollment in and
conduct of its clinical trials, and obtaining data from clinical
trials, in each case for a variety of reasons, including the
difficulty and uncertainty of pharmaceutical product development,
unexpected adverse events or regulatory action, and the inherent
uncertainty associated with the regulatory approval process.
Seattle Genetics may also be unable to expand ADCETRIS’ labeled
indications due to the failure of its ongoing phase 3 trials to
support new regulatory approvals, adverse FDA or other regulatory
actions, or for other reasons, and Seattle Genetics may also be
unable to complete the development of, and obtain regulatory
approval for, its product candidates. 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 March 31, 2017
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.
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version on businesswire.com: http://www.businesswire.com/news/home/20170619005466/en/
Seattle Genetics, Inc.Investors:Peggy Pinkston,
425-527-4160ppinkston@seagen.comorMedia:Brandi Robinson,
425-527-2910brobinson@seagen.com
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