-Clinical Data Featured in Press Program and
Oral Presentation Indicate 33A is Well Tolerated in Combination
with 7+3 Induction Therapy in Younger Newly Diagnosed AML
Patients-
-Antileukemic Activity Data Show Remission Rate
of 76 Percent, with 78 Percent of Those Remissions Negative for
Minimal Residual Disease-
Seattle Genetics, Inc. (NASDAQ: SGEN), a global biotechnology
company, today highlighted phase 1b data evaluating vadastuximab
talirine (SGN-CD33A; 33A) in combination with the frontline
standard of care regimen for induction (cytarabine and
daunorubicin, also known as 7+3) for younger patients with newly
diagnosed acute myeloid leukemia (AML) in an oral presentation at
the 58th American Society of Hematology (ASH) Annual Meeting and
Exposition taking place in San Diego, California, December 3-6,
2016. The data were also featured in an ASH press program and
selected to be included in the 2017 Highlights of ASH post-meeting
program. 33A is an investigational antibody-drug conjugate (ADC)
targeted to CD33, a protein which is expressed on leukemic cells in
nearly all AML patients.
“Our clinical trial data reported at ASH demonstrate that adding
vadastuximab talirine, also known as 33A, to standard of care
treatment results in a rapid, high rate of remissions in frontline,
younger AML patients with poor prognosis. Notably, seventy-eight
percent of patients who achieved remissions in this trial tested
negative for minimal residual disease, which means no cancer could
be detected with a sensitive test,” said Jonathan Drachman, M.D.,
Chief Medical Officer and Executive Vice President, Research and
Development at Seattle Genetics. “In this trial, 33A in combination
with 7+3 was well-tolerated, with a low early mortality rate. Based
on these promising, early data, we plan to initiate a randomized
phase 2 clinical trial in 2017 in younger newly diagnosed AML
patients to further evaluate the potential benefit of adding 33A to
standard of care.”
“People with acute myeloid leukemia die of infections or
bleeding within weeks or a few months of diagnosis without
effective, aggressive chemotherapy. Even with current treatment
regimens, fewer than 50% of younger adults are successfully
treated. The phase 1 results of 33A in combination with standard of
care show a high rate of remissions in younger newly diagnosed AML
patients without significantly adding to the toxicity of the
treatment. Notably, 94 percent of remissions occur with only one
cycle of treatment,” said Harry P. Erba, M.D., Ph.D., University of
Alabama-Birmingham and presenter of the phase 1 data at ASH.
“Furthermore, the majority of these patients have no evidence of
disease following the 33A combination even using a very sensitive
test for residual leukemia (minimal residual disease negative). The
rate at which patients become minimal residual disease negative
following 33A combination treatment offers encouraging preliminary
evidence that 33A in combination with 7+3 could reduce relapse
rates and improve long-term outcomes for these patients.”
The following interim results from the ongoing phase 1 study
evaluating 33A in combination with 7+3 in frontline AML will be
presented by Dr. Harry P. Erba, University of Alabama-Birmingham,
in an oral session on Saturday, December 3, 2016:
A Phase 1b Study of Vadastuximab Talirine in Combination with
7+3 Induction Therapy for Patients with Newly Diagnosed Acute
Myeloid Leukemia (AML) (Abstract #211, oral presentation on
Saturday, December 3, 2016 at 4:00 p.m. PT)
Data were reported from 42 newly diagnosed AML patients with a
median age of 46 years and intermediate or adverse cytogenetic risk
of 50 percent and 36 percent, respectively. Seventeen percent of
patients had secondary AML. Key findings include:
- Of 42 patients evaluable for response,
32 patients (76 percent) achieved a complete remission (CR) or
complete remission with incomplete platelet or neutrophil recovery
(CRi). Ninety-four percent of the remissions (CR or CRi) occurred
with one cycle of therapy.
- Twenty-five of the 32 patients (78
percent) who achieved remission were negative for minimal residual
disease (MRD). MRD-negative remission post-induction is generally
correlated with reduced rates of relapse and improved overall
survival.
- Remissions were observed in higher-risk
patients, including 18 of 21 (86 percent) and nine of 15 (60
percent) patients with intermediate or adverse cytogenetics,
respectively.
- Overall survival (OS) is still evolving
and median OS has not yet been reached. The 30-day mortality rate
was two percent. Twenty-one of 42 patients (50 percent) went on to
receive an allogenic stem cell transplant.
- The most common Grade 3 or 4
treatment-emergent adverse events occurring in 20 percent or more
of patients were febrile neutropenia, thrombocytopenia, anemia and
neutropenia. No non-hematologic treatment-emergent adverse events
of Grade 3 or higher were reported in 15 percent or more of
patients. No veno-occlusive disease/sinusoidal obstruction syndrome
or significant hepatotoxicity was observed on treatment.
- The most common Grade 1 and 2
treatment-emergent adverse events occurring in 20 percent or more
of patients were nausea, diarrhea, constipation, hypokalemia and
decreased appetite. No infusion-related reactions occurred.
- This phase 1 study continues to enroll
patients. A randomized phase 2 trial of 33A plus 7+3 versus 7+3
alone is planned.
Seattle Genetics is broadly evaluating 33A across multiple lines
of therapy in patients with myeloid malignancies. The ongoing
global phase 3 CASCADE study is a randomized, double-blind,
multi-center trial designed to evaluate 33A in combination with
hypomethylating agents (HMAs) in approximately 500 previously
untreated AML patients. Further, phase 1 and 2 clinical trials for
relapsed AML and for previously untreated myelodysplastic syndrome
(MDS) are currently underway. More information about 33A and
ongoing clinical trials can be found at www.ADC-CD33.com.
About Acute Myeloid Leukemia
Acute myeloid leukemia, also called acute myelocytic leukemia or
AML, is an aggressive cancer of the bone marrow and blood that
progresses rapidly without treatment. Cancerous cells called
leukemic blasts multiply and crowd out normal cells in the bone
marrow and interfere with normal blood cell production leading to
anemia, infection, and bleeding. According to the SEER database and
Kantar Health Sciences, in 2016 approximately 33,000 new cases of
AML (mostly in adults) will be diagnosed in the U.S. and Europe. In
the U.S. alone, nearly 10,500 deaths will occur from AML this year.
Treatment options for AML have remained virtually unchanged for
nearly 40 years and frontline treatment consists primarily of
chemotherapy. A subset of patients (typically those over 60 years
of age) cannot tolerate such therapy and are typically given lower
intensity agents, supportive care, or are recommended for clinical
trials.
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 therapeutic
potential of SGN-CD33A, the possibility that 33A may be combined
with existing standard of care agents for AML and the planned
randomized clinical trial. 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 show sufficient activity in
subsequent clinical trial(s) and the risk of adverse events as
SGN-CD33A advances in clinical trials and regulatory actions. 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.
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version on businesswire.com: http://www.businesswire.com/news/home/20161203005005/en/
Seattle Genetics, Inc.Investors:Peggy Pinkston,
425-527-4160ppinkston@seagen.comorMedia:Kavita V. Shah, Ph.D.,
425-527-4188kshah@seagen.com
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