Sunesis Announces Study Examining the Value of Complete Remission Prior to HCT in Patients with AML Presented at 2016 ASCO An...
June 06 2016 - 9:12AM
Sunesis Pharmaceuticals, Inc. (NASDAQ:SNSS) today announced the
presentation of results from a study conducted by the Center for
International Blood and Marrow Transplant Research (CIBMTR) at the
Medical College of Wisconsin evaluating the value of achieving
complete remission prior to allogeneic hematopoietic cell
transplantation (HCT) in patients with acute myeloid leukemia
(AML). The study was funded jointly by Sunesis and CIBMTR. The
results are being presented today, Monday, June 6th from 8:00 a.m.
to 11:30 a.m. Central Time at the Hematologic Malignancies –
Leukemia, Myelodyplastic Syndromes, and Allotransplant General
Poster Session of the 2016 American Society of Clinical Oncology
(ASCO) Annual Meeting taking place in Chicago, Illinois.
The poster presentation (Poster #25, Abstract
7033, Hall A), titled “Allogeneic transplantation for advanced
acute myelogenous leukemia: The value of complete remission,” will
be available on the Sunesis website at www.sunesis.com, following
the ASCO presentation.
For the study, researchers evaluated records
from 4,382 patients with AML who had proceeded to allogeneic
transplantation to understand comparative survival between those in
complete remission following additional salvage therapy and those
receiving prompt HCT without achieving complete remission or in
first relapse following primary induction. Of the 4,382
patients, 1,440 had transplantation in primary induction failure
(PIF), 1,256 were first relapse (Rel1), and 1,986 had achieved a
second complete remission (CR2). Baseline characteristics were
similar in the three disease status groups.
The results showed that more patients who had
achieved CR2 had de novo AML, a longer duration of a first complete
remission (CR1), and were more likely to report performance scores
of 90 or 100. Adverse cytogenetics were more common in PIF patients
and duration of CR1 was shorter in patients with Rel1 than in those
with CR2. Mortality was higher for HCT in Rel1 compared to CR2
regardless of CR1 duration (RR 1.65, p < 0.0001). Similarly,
mortality was higher for HCT in PIF compared to CR2 with CR1
duration < 6 (RR 1.26, p < 0.0001), 6-12 (RR 1.60, p <
0.0001) and > 12 months (RR 2.24, p < 0.0001). The
probabilities of overall survival by disease status at 6 months
are: CR2 73 (71-75)%; Rel1 53 (50-55)%; PIF 58 (56-61)%; and at 2
years, CR2 50 (48-52)%; REL1 27 (24-29)%; PIF 29 (27-32)%.
The data suggest that patients in remission fare
better following HCT than those who receive transplant without
having achieved CR, and that the ability to achieve remission is a
powerful prognostic marker.
“These data point to the importance of achieving
remission as an indicator of prognosis after HCT for patients with
relapsed/refractory AML, and underscore the need for an effective
salvage therapy,” said Parvinder S. Hyare, Vice President, Global
Oncology Operations and an author of the study. “We thank CIBMTR
and their collaborators for this important research, and continue
to work toward delivering new treatment options to high unmet need
patients with AML around the world.”
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, potential ex-US partnership, and
the expected progress in its kinase inhibitor pipeline. Words such
as “prospects,” “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-Q for
the year ended May 9, 2015 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.
About CIBMTR® (Center for International Blood and Marrow
Transplant Research®)A research collaboration between the
National Marrow Donor Program® (NMDP)/Be The Match® and the Medical
College of Wisconsin, CIBMTR facilitates critical, cutting-edge
research that has led to increased survival and an enriched quality
of life for thousands of patients. CIBMTR collaborates with the
global scientific community to advance hematopoietic cell
transplantation and cellular therapy research worldwide. The
prospective and observational research is accomplished through
scientific and statistical expertise, a large network of transplant
centers and clinical database of more than 425,000 transplant
recipients.
Investor and Media Inquiries:
David Pitts
Argot Partners
212-600-1902
Eric Bjerkholt
Sunesis Pharmaceuticals Inc.
650-266-3717
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