Sunesis Pharmaceuticals (NASDAQ:SNSS) today announced the
presentation of updated results from an ongoing Phase 1b/2
University of Texas MD Anderson Cancer Center-sponsored trial of
vosaroxin in combination with decitabine in older patients with
previously untreated acute myeloid leukemia (AML) and high-risk
myelodysplastic syndrome (MDS). The results were presented Saturday
in an oral session titled “New Compounds in AML Treatment” at the
21st Congress of the European Hematology Association (EHA) in
Copenhagen, Denmark. The presentation (abstract S505, Bella Center,
Hall A3), titled “Phase I/ll study of vosaroxin and decitabine in
newly diagnosed older patients with acute myeloid leukemia and
high-risk myelodysplastic syndrome,” is available at
www.sunesis.com.
“Older patients diagnosed with AML and MDS have
limited treatment options and exceedingly poor outcomes,” said
Naval Daver, M.D., Assistant Professor, Department of Leukemia,
University of Texas MD Anderson Cancer Center, and a study
investigator. “At the optimized induction dose of 70 mg/m2 of
vosaroxin, the combination of vosaroxin and decitabine demonstrates
a compelling CR/CRp/CRi rate of 76% and a median overall survival
of 16.1 months. This response rate and survival are
significantly better than seen with single-agent decitabine among
similar patients at our institution. This outcome was achieved with
<5% induction mortality and good tolerability. In this
vosaroxin-decitabine cohort, 23 of 41 patients remain
alive.”
Daniel Swisher, CEO of Sunesis, added: “We believe these results
warrant further exploration in a larger outcome study, with plans
currently under review to conduct a multicenter clinical trial
comparing vosaroxin plus decitabine and vosaroxin plus cytarabine
to the 7+3 regimen in patients with AML.”
To date, 63 patients (56 AML, 7 high-risk MDS)
with a median age of 69 years (range 60-78) have been enrolled in
the trial. All 63 patients have completed at least 2 treatment
rounds, rendering them evaluable for response; with a 75% overall
response rate, 49% (31 patients) achieved complete remission (CR),
17% (11 patients) achieved CR with incomplete platelet recovery
(CRp), and 8% (5 patients) achieved CR with incomplete peripheral
blood count recovery (CRi). The therapy was well-tolerated, with
the main therapy related grade 3 or higher toxicities being
mucositis in 11 (17%) patients.
Initially for the first 22 patients in the
study, the selected induction dose of vosaroxin was 90 mg/m2.
Thereafter to reduce the incidence of mucositis, the induction dose
was reduced to 70 mg/m2 for the next 41 patients. The lower dose of
vosaroxin in combination with decitabine was associated with
reduced early mortality and an improved overall response rate and
OS, as follows:
Induction Dose(vosaroxin) |
N |
Median OS |
8-week Mortality |
Overall Response |
Need >1 Cycle to Response |
90 mg/m2 |
22 |
5.5 |
|
27 |
% |
|
73 |
% |
|
19 |
% |
70 mg/m2 |
41 |
16.1 |
|
5 |
% |
|
76 |
% |
|
42 |
% |
Sunesis also announced that follow-up data from
the company’s VALOR trial was presented as an e-poster during the
EHA meeting. The poster (abstract E930, Bella Center, E-Poster
Screens), titled “Characterization of patients with relapsed or
refractory AML in continued follow-up after treatment with
vosaroxin/cytarabine vs placebo/cytarabine in the VALOR trial,”
shows that, as of January 22, 2016, 83 of 711 patients enrolled in
VALOR remain alive (46/356 in the vosaroxin/cytarabine arm, 37/355
in the placebo/cytarabine arm) and in follow up, which has reached
a median of 40 months. In patients ≥60 years, more than twice
as many patients were alive in the vosaroxin/cytarabine arm (23 vs.
10 patients).
All but seven patients in this follow up
underwent allogeneic hematopoietic stem cell transplant
(HCT). Of note, the non-HCT survivors were all in the
vosaroxin/cytarabine treatment arm (68-71 years old, 2 primary
refractory and 5 early relapsed).
Mr. Swisher added: “We are encouraged by the
long-term benefit seen in the VALOR follow-up and also the
potential for vosaroxin and cytarabine to provide long-term benefit
in older patients who need more options.”
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 improving the lives of people
with cancer and is currently 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. In addition, the company is advancing its
kinase-inhibitor pipeline of novel targeted therapies into the
clinic.
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 anticipated progress and potential
approval of vosaroxin by the EMA, and further clinical development
of vosaroxin,. Words such as “believe,” “look forward,”
"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 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, the risk that Sunesis' clinical studies for 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, risks related to Sunesis' need
for substantial additional funding to complete the development and
commercialization of vosaroxin and other product candidates, 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 March 31, 2016, when
available, 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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