Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) today announced the
presentation of results from a Washington University-sponsored
Phase 1 trial of vosaroxin plus azacitidine in patients with
myelodysplastic syndrome, and from an analysis of the Company's
Phase 3 VALOR trial of vosaroxin and cytarabine in
relapsed/refractory acute myeloid leukemia (AML) at the 57th
American Society of Hematology Annual Meeting in Orlando, Florida.
The posters, titled "A Phase I Study of Vosaroxin plus Azacitidine
for Patients with Myelodysplastic Syndrome" (publication number
1686) and "Baseline Predictors of Mortality in Patients with
Relapsed or Refractory Acute Myeloid Leukemia Treated with
Vosaroxin Plus Cytarabine or Placebo plus Cytarabine in the Phase 3
VALOR Study" (publication number 2560) are available at
www.sunesis.com.
A Phase I Study of Vosaroxin Plus Azacitidine for
Patients with Myelodysplastic Syndrome
In a Phase 1/2, open label, dose-escalation trial sponsored by
the Washington University School of Medicine, patients with MDS who
may have received up to three prior cycles of hypomethylating
agent-based therapy were given vosaroxin and azacitidine for a
maximum of six cycles. The Phase 1 portion of the study was
designed to determine the maximum tolerated dose and dose limiting
toxicity of the combination. Other endpoints include best response,
safety, tolerability, and event-free, progression-free,
disease-free and overall survival.
Thirteen patients were enrolled in the dose-escalation phase and
five of twenty planned patients have been enrolled in the expansion
cohort to date. At the initial dose of 50 mg/m2/day vosaroxin, 2 of
6 patients experienced a DLT (grade 4 hyperbilirubinemia, and grade
4 neutropenia >42 days). The vosaroxin dose was de-escalated to
34 mg/m2/day, resulting in 1 of 6 patients with a DLT (grade 4
mucositis). Of the 18 patients enrolled to date, 16 completed ≥1
cycle and are evaluable for response. Best response for each
patient was as follows: stable disease, n=3; stable disease with
hematologic improvement (HI)-neutrophils, n=2; marrow complete
remission (CR), n=4; marrow CR with HI-platelets; n=2; marrow CR
with HI-neutrophils, n=1; marrow CR with HI-erythroid, n=1; and
marrow CR with HI-platelets and neutrophils, n=1; and CR, n=1. One
patient had progressive disease (PD). Of the 16 evaluable patients,
6 have proceeded to allogenic stem cell transplant and 3 are
actively undergoing study treatment. The major non-hematologic
toxicities of febrile neutropenia, infections, and mucositis were
expected based on the disease population and prior experiences with
vosaroxin.
"Hypomethlyating agents are the mainstay of treatment for
myelodysplastic syndromes, yet these agents alone produce
remissions in a minority of patients and are typically not
curative," said Meagan A. Jacoby, M.D., Ph.D., Assistant Professor,
Division of Oncology, Washington University School of Medicine, and
principal investigator of the study. "The combination of vosaroxin
and azacitidine show promising activity with response rates
comparable or better than those generally observed with azacitidine
alone. Additionally, the transplant rate observed is encouraging in
this patient population with a median age of 66 years. We look
forward to additional patient accrual and follow up from this
study."
Baseline Predictors of Mortality in Patients with
Relapsed or Refractory Acute Myeloid Leukemia Treated with
Vosaroxin Plus Cytarabine or Placebo Plus Cytarabine in the Phase 3
VALOR Study
Treatment-related mortality (TRM) score is a prognostic scoring
system to predict risk of 30-day mortality with intensive treatment
protocols in patients with newly diagnosed AML (Walter, 2011, J
Clin Oncol 29:4417-4424). The "simplified TRM" score includes age,
performance status (PS), platelet count, serum albumin, type of AML
(secondary vs primary), white blood cell count, blast percentage in
the peripheral blood, and serum creatinine. In a retrospective
analysis, TRM and other criteria were used to evaluate risk of
early mortality in patients with relapsed or refractory acute
myeloid leukemia treated with vosaroxin plus cytarabine or placebo
plus cytarabine in Sunesis' randomized, double-blind,
placebo-controlled Phase 3 VALOR trial.
A total of 705 patients from VALOR were included in the safety
population (355 treated with vosaroxin/cytarabine and 350 treated
with placebo/cytarabine). Rates of 30-day (7.9% vs 6.6%,
respectively) and 60-day (19.7% vs 19.4%, respectively) mortality
in VALOR were comparable between vosaroxin plus cytarabine and
placebo plus cytarabine arms. Several individual baseline factors
independently predicted risk of early mortality, including ECOG
performance status, hemoglobin, bilirubin and albumin levels,
intermediate or high bone marrow blasts, and prior myelodysplastic
syndrome. The previously validated TRM score for predicting early
mortality in newly diagnosed AML was also predictive of mortality
in this relapsed/refractory population. Vosaroxin/cytarabine
treatment and age were not significant predictors of early
mortality.
"The rate of early mortality in patients treated for acute
myeloid leukemia reflects a balance of efficacy and safety
outcomes," said Dr. Jeffrey Lancet, Senior Member and Professor of
Oncologic Sciences at the H. Lee Moffitt Cancer Center, Tampa,
Florida. "The ability to assess increased risk of early mortality
in this disease would provide valuable information in guiding
treatment decisions. Based on this analysis, patient selection for
future studies of vosaroxin and other intensive regimens in the AML
setting may benefit from use of these predictive factors."
About QINPREZO™ (vosaroxin)
QINPREZO™ (vosaroxin) is an anti-cancer quinolone derivative
(AQD), a class of compounds that has not been used previously for
the treatment of cancer. Preclinical data demonstrate that
vosaroxin both intercalates DNA and inhibits topoisomerase II,
resulting in replication-dependent, site-selective DNA damage, G2
arrest and apoptosis. Both the U.S. Food and Drug Administration
(FDA) and European Commission have granted orphan drug designation
to vosaroxin for the treatment of AML. Additionally, vosaroxin has
been granted fast track designation by the FDA for the potential
treatment of relapsed or refractory AML in combination with
cytarabine. Vosaroxin is an investigational drug that has not been
approved for use in any jurisdiction.
The trademark name QINPREZO is conditionally accepted by the FDA
and the EMA as the proprietary name for the vosaroxin drug product
candidate.
About Sunesis Pharmaceuticals
Sunesis is a biopharmaceutical company focused on the
development and commercialization of new oncology therapeutics for
the potential treatment of solid and hematologic cancers. Sunesis
has built a highly experienced cancer drug development organization
committed to advancing its lead product candidate, vosaroxin, in
multiple indications to improve the lives of people with
cancer.
For additional information on Sunesis, please visit
http://www.sunesis.com.
SUNESIS and the logos are trademarks of Sunesis Pharmaceuticals,
Inc.
This press release contains forward-looking statements,
including statements related to Sunesis' expected progress in its
kinase inhibitor pipeline. Words such as "may," "expect,"
"intends," "plan," "potential," "will" and similar expressions are
intended to identify forward-looking statements. These
forward-looking statements are based upon Sunesis' current
expectations. Forward-looking statements involve risks and
uncertainties. Sunesis' actual results and the timing of events
could differ materially from those anticipated in such
forward-looking statements as a result of these risks and
uncertainties, which include, without limitation, the risk that
Sunesis' clinical studies for its product candidates may not
demonstrate safety or efficacy or lead to regulatory approval, the
risk that data to date and trends may not be predictive of future
data or results, risks related to the conduct of Sunesis' clinical
trials, risks related to Sunesis' need for substantial additional
funding to complete the development and commercialization of
vosaroxin, and risks related to Sunesis' ability to raise the
capital that it believes to be accessible and is required to fully
finance the development and commercialization of vosaroxin. These
and other risk factors are discussed under "Risk Factors" and
elsewhere in Sunesis' Quarterly Report on Form 10-Q for the quarter
ended September 30, 2015. Sunesis expressly disclaims any
obligation or undertaking to release publicly any updates or
revisions to any forward-looking statements contained herein to
reflect any change in Sunesis' expectations with regard thereto or
any change in events, conditions or circumstances on which any such
statements are based.
CONTACT: Investor and Media Inquiries:
David Pitts
Argot Partners
212-600-1902
Eric Bjerkholt
Sunesis Pharmaceuticals Inc.
650-266-3717
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