Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) today announced the
presentation of a responder survival analysis from the Phase 3
VALOR trial at the 33rd Annual Chemotherapy Foundation Symposium
(CFS) taking place at the Marriott Marquis in New York City. The
results are being presented today, Wednesday, November 4th, at 6:00
p.m. as a poster during the general poster session in the Exhibit
Hall.
The poster presentation, titled "Impact of Complete Remission on
Overall Survival in Patients with Refractory/Relapsed Acute Myeloid
Leukemia Treated with Vosaroxin Plus Cytarabine or Placebo Plus
Cytarabine: Responder Analysis for the Phase 3 VALOR Trial," will
be available on the Sunesis website at www.sunesis.com, following
the conclusion of the symposium.
VALOR is a randomized, double-blind, placebo-controlled Phase 3
trial which enrolled 711 adult patients with first relapsed or
refractory AML at 124 leading sites in 15 countries. Patients were
stratified for age, geographic region and disease status and
randomized one to one to receive either vosaroxin and cytarabine or
placebo and cytarabine. The full results from VALOR were recently
published in the September 2015 print issue of The Lancet
Oncology.
A post hoc landmark analysis was performed comparing overall
survival (OS) by complete remission (CR) status. To mitigate the
potential bias that early death would preclude CR, only patients
alive at 60 days were included. Of the 711 patients in the
VALOR intent-to-treat population, 570 patients were alive at the
60-day mark, including 285/356 (80%) in the vosaroxin/cytarabine
arm and 285/355 (80%) in the placebo/cytarabine arm. At 60 days,
the CR rate was 33.0% and 15.4% in the respective treatment arms.
The addition of vosaroxin produced the greatest percentage increase
in CR rate compared to the control arm in patients ≥ 60 y of age,
patients with high blast count, and patients with refractory or
early relapsed disease. These same patient groups also show the
greatest OS benefit with the addition of vosaroxin. In both
treatment arms and all study-strata, achievement of CR was
associated with consistently longer median OS; patients with CR at
60 days had a median OS of 20.1 months (21.2 months with
vosaroxin/cytarabine and 19.8 months with placebo/cytarabine), and
patients without CR had a median OS of 7.1 months (7.3 and 7.1
months, respectively). Irrespective of treatment arm, OS was
consistently prolonged in patients with CR. The stratified
Chi-square statistical analysis of survival demonstrated a HR for
CR of 0.42.
"These data underscore the long-held clinical understanding that
CR status is the strongest independent predictor of overall
survival in patients with AML, with VALOR demonstrating a two-fold
increase in CR with the addition of vosaroxin," said Harry Erba,
MD, PhD, Professor of Medicine and Director of the Hematologic
Malignancy Program at the University of Alabama at
Birmingham. "Importantly, the CR benefit, and thus survival
benefit, conveyed by the addition of vosaroxin is most evident in
patients over 60 years of age and those with refractory or early
relapsed disease. These data further demonstrate the potential of
vosaroxin as a much needed new treatment option for patients with
relapsed or refractory AML."
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 AML
AML is a rapidly progressing cancer of the blood characterized
by the uncontrolled proliferation of immature blast cells in the
bone marrow. The American Cancer Society estimates that there
will be approximately 20,830 new cases of AML and approximately
10,460 deaths from AML in the U.S. in 2015. Additionally, it is
estimated that the prevalence of AML across major global markets
(U.S., France, Germany, Italy, Spain, United
Kingdom and Japan) is over 75,000. AML is generally a
disease of older adults, and the median age of a patient diagnosed
with AML is about 67 years. AML patients with relapsed or
refractory disease and newly diagnosed AML patients over 60 years
of age with poor prognostic risk factors typically die within one
year, resulting in an acute need for new treatment options for
these patients.
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' estimated timelines for
regulatory interactions and regulatory progress, including the
anticipated submission of the MAA for vosaroxin with the EMA and
plans to gain marketing approval of vosaroxin in the U.S., Sunesis'
overall strategy, the design, conduct and results of clinical
trials, including the expected progress in its kinase inhibitor
pipeline, estimated new cases of AML, its prevalence across major
global markets, prognosis for patients with AML, the need for and
the role of vosaroxin as a potential new treatment option, and
Sunesis' clinical development of vosaroxin, including the analysis
of the results from the VALOR clinical trial. Words such as
"anticipates," "estimates," "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 may not be able
to submit timely the MAA to the EMA, the risk that Sunesis'
clinical studies for vosaroxin may not lead to regulatory approval
in the U.S. or Europe, that Sunesis' development activities for
vosaroxin could be otherwise halted or significantly delayed for
various reasons, the risk that Sunesis' clinical studies for
vosaroxin or other 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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