Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) today announced the
presentation of updated results from the VALOR trial examining
overall survival in patients age 60 years and older with
relapsed/refractory AML. The results are being presented today at
3:15 PM PT in an oral session titled “Acute Myeloid Leukemia: Novel
Therapy, excluding Transplantation: Clinical trials of Novel Drugs
and Combinations in AML” taking place from 2:45 PM – 5:45 PM PT at
the 58th American Society of Hematology Annual Meeting in San
Diego, California. The presentation (abstract 903, Marriott Marquis
San Diego Marina, Ballroom AB), titled “Durable Overall Survival
Benefit in Patients ≥ 60 Years with Relapsed or Refractory AML
Treated with Vosaroxin/Cytarabine Vs Placebo/Cytarabine: Updated
Results from the Valor Trial,” is available at www.sunesis.com.
"Clinical outcomes among patients with
relapsed/refractory AML remain abysmal, particularly among older
patients,” said Farhad Ravandi, M.D., Professor of
Medicine, Department of Leukemia, University of Texas MD
Anderson Cancer Center, and a principal investigator of the VALOR
study. "Results from the updated survival data from VALOR and the
post-hoc analyses presented today, show compelling durable survival
outcomes among older patients, and support the use of vosaroxin, in
combination with cytarabine, as an important treatment option for
this group of AML patients desperately in need of new
therapies.”
VALOR is a randomized, double-blind,
placebo-controlled Phase 3 trial that enrolled 711 adult patients
with first relapsed or refractory AML at 124 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. At the time of the primary
analysis in October 2014, the overall survival (OS) was
significantly improved with vosaroxin/cytarabine versus
placebo/cytarabine in patients age 60 years and older (7.1 months
vs 5.0 months, HR=0.75, p=0.0030), with a complete remission (CR)
rate of (31.9% vs 13.8%, p < 0.0001).
The new data presented today from the VALOR
trial include an updated survival analysis in the 451 patient
subset age 60 and older, sensitivity analyses of OS in patients age
60 and older, and analyses examining the differences in treatment
effect by age. The results demonstrate that, after a median of 39.9
months of follow-up, OS for patients age 60 years and older remains
significantly improved for the vosaroxin/cytarabine arm compared to
the placebo/cytarabine arm (figure 1), with survival curves
remaining separated through 48 months.
Figure 1.
A graph accompanying this announcement is
available
at http://www.globenewswire.com/NewsRoom/AttachmentNg/7db20a54-6b19-4353-b1e0-65c36ec84063
Treatment Arm |
Patients, n |
Events, n (%) |
Censored, n (%) |
Median OS (95% CI) |
P value (2-sided) |
Pla+Cyt |
225 |
212 (94.2%) |
13 (5.8%) |
5.0 (3.8-6.4) |
0.0017 |
Vos+Cyt |
226 |
199 (88.1%) |
27 (11.9%) |
7.1 (5.8-8.1) |
Of note, twice as many patients were alive on
the vosaroxin-containing arm at both the 24 and 36 months’ time
points highlighting the durability of benefit observed in this
patient group.
An OS benefit with the addition of vosaroxin was
observed consistently across smaller subgroups above 60 years
(figure 2). Smaller age groups below 60 years did not demonstrate a
similar OS benefit.
Figure 2.
|
Median OS, months |
Patent Age |
Vosaroxin/Cytarabine |
Placebo/Cytarabine |
Hazard Ratio (95% CI) |
60-64 years (n = 124) |
8.1 |
5.2 |
0.72 (0.49-1.06) |
65-74 years (n = 293) |
7.0 |
5.0 |
0.76 (0.60-0.97) |
75-84 years (n = 34) |
5.5 |
3.3 |
0.72 (0.36-1.45) |
Sunesis also performed a multivariate survival
analysis adjusting for baseline prognostic factors. In this
analysis, the HR for OS in the ITT population was 0.80 (p=0.0114)
and for patients age 60 and older the OS HR was 0.68
(p=0.0004).
“All of these data and analyses further
underscore the consistency, durability and robustness of the
survival benefit for patients age 60 years and older who received
vosaroxin in the VALOR study,” said Daniel Swisher, President and
Chief Executive Officer of Sunesis. “As we work toward a European
regulatory decision for vosaroxin in this patient population, we
remain committed to making vosaroxin available as a new treatment
option for underserved patients with relapsed refractory AML.
As our regulatory efforts progress, we also continue to
advance active dialogues with potential pharma collaborators toward
the goal of supporting a European market launch in 2017.”
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. Vosaroxin is an
investigational drug that has not been approved for use in any
jurisdiction.
Vosaroxin’s Marketing Authorization Application
for relapsed refractory AML is currently under review by
the European Medicines Agency, and a regulatory decision
regarding approval is expected in 2017.
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 improving the lives of people
with cancer. Currently, the company is focused on pursuing
regulatory approval in Europe for its lead product candidate,
vosaroxin, for the treatment of relapsed or refractory acute
myeloid leukemia in patients aged 60 and older, as well as
advancing its novel kinase-inhibitor pipeline, which includes its
proprietary non-covalent BTK-inhibitor, SNS-062.
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' corporate
objectives, including the regulatory development and potential
approval of vosaroxin by the EMA, potential collaborations and
ability to commercialize vosaroxin in Europe. Words such as
“expect,” “goal,” “may,” "potential" “advancing,” “anticipate,”
“progress” 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 receive regulatory approval of
vosaroxin in the U.S. or Europe, that Sunesis' development
activities for vosaroxin could be otherwise halted or significantly
delayed for various reasons, risks related to Sunesis' need for
substantial additional funding to complete the development and
commercialization of vosaroxin and other product candidates, the
risk that Sunesis' clinical studies for SNS-062, vosaroxin or other
product candidates, including its pipeline of kinase inhibitors,
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, 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 and other product candidates. These and other risk
factors are discussed under "Risk Factors" and elsewhere in
Sunesis' Annual Report on Form 10-K for the year
ended December 31, 2015, Sunesis’ Quarterly Report on Form
10-Q for the quarter ended September 30, 2016, and Sunesis' other
filings with the Securities and Exchange Commission.
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.
Investor and Media Inquiries:
David Pitts
Argot Partners
212-600-1902
Eric Bjerkholt
Sunesis Pharmaceuticals Inc.
650-266-3717
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