Sunesis Pharmaceuticals Announces Presentation of Positive Results From MD Anderson Sponsored Trial in AML at ASH Annual Meet...
December 07 2015 - 7:00AM
Sunesis Pharmaceuticals, Inc. (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
myelodyplastic syndrome (MDS). The results are being presented
today at 8:00 AM in an oral session titled "Acute Myeloid Leukemia:
Novel Therapy, excluding Transplantation: New Epigenetic
Approaches" taking place from 7:00 AM to 8:30 AM ET at the 56th
American Society of Hematology Annual Meeting in Orlando, Florida.
The presentation (abstract 461, Orange County Convention Center,
W109), titled "Phase I/II Study of Vosaroxin and Decitabine in
Newly Diagnosed Older Patients (pts) with Acute Myeloid Leukemia
(AML) and High Risk Myelodyplastic Syndrome (MDS)," is available at
www.sunesis.com.
"Inability to tolerate frontline chemotherapy greatly limits
treatment options and worsens prognoses among older patients with
newly diagnosed AML and MDS," said Naval Daver, M.D., Assistant
Professor, Department of Leukemia, University of Texas MD Anderson
Cancer Center, and a study investigator. "This study demonstrates
compelling outcomes both for the high rate of complete remission
seen with vosaroxin and decitabine, historically the best predictor
or overall survival, and the tolerability of the combination.
Particularly noteworthy are outcomes in patients who received the
70 mg/m2 induction dose of vosaroxin, where early mortality is low
and overall survival is very promising."
To date, 61 patients (54 AML, 7 high-risk MDS) with a median age
of 69 years (range, 60-78) have been enrolled in the Phase 1b/2
trial. All 61 patients have completed at least 2 cycles of therapy
and were evaluable for response: 32 patients (52%) achieved
complete response (CR), 9 patients (15%) achieved CR with
incomplete platelet recovery (CRp), and 4 patients (7%) achieved CR
with incomplete peripheral blood count recovery (CRi) for an
overall response rate of 74%. Minimal residual disease (MRD) by 19
color flow-cytometry was evaluable in 33 of the 45 responders. MRD
was not detectable in 22 of 33 (67%) evaluable responders. The
median number of cycles to response was 1; 15 patients have
required >1 cycle to achieve response. Eleven (19%) patients
have proceeded to allogeneic stem cell transplant. The median
follow-up is 7.7 months (2.2 – 24.5). The regimen was well
tolerated with the main therapy related grade 3 or higher
non-infectious toxicities being mucositis in 11 (18%) patients and
elevated bilirubin in 8 (13%) patients.
Median overall survival (OS) for all patients is 8.8 months.
Four-week and 8-week mortality for all patients were 0 and 13%,
respectively. The induction dose of vosaroxin was 90 mg/m2 in 22
patients and 70 mg/m2 in 39 patients. The lower induction dose of
vosaroxin was associated with a reduced early mortality and an
improved overall response rate and OS, as follows:
Induction dose |
N |
Med OS |
8-week mortality |
Overall Response |
CR |
Need >1 cycle to
response |
(vosaroxin) |
|
|
|
|
|
|
90 mg/m2 |
22 |
5.5 mos |
27% |
73% |
41% |
19% |
70 mg/m2 |
39 |
10.9 mos |
5% |
77% |
62% |
40% |
Patients were also assessed for response by baseline
characteristics, including mutation status. Responses among these
patients were as follows:
Parameter |
Category |
N |
Overall response |
CR |
Age |
60-69 |
29 |
78% |
57% |
|
>/=70 |
17 |
71% |
42% |
Cytogenetics |
Diploid |
19 |
83% |
57% |
|
Miscellaneous |
13 |
76% |
63% |
|
-5/-7/other adverse |
14 |
67% |
42% |
Mutation |
IDH2 |
10 |
91% |
73% |
Status |
TP53 |
9 |
75% |
55% |
|
RAS |
6 |
67% |
28% |
|
IDHT |
3 |
33% |
43% |
"This trial continues to reinforce observations from VALOR and
other studies of vosaroxin, in the front-line and relapsed
refractory AML settings, demonstrating that vosaroxin can become a
new backbone of treatment and in combination with other important
therapeutic candidates can increase the rates of complete response,
translating to promising overall survival," said Daniel Swisher,
Chief Executive Officer of Sunesis. "We look forward to exploring
vosaroxin's treatment potential within other segments of the AML
and MDS disease spectrum through a comprehensive program of
investigator-led and Sunesis-led studies."
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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