Market Overview

UPDATE: Sunesis Reports Schedule C Had Most Favorably Safety/Efficacy Balance


Pharmaceuticals, Inc. (Nasdaq: SNSS) today announced the publication of results
from the Company's REVEAL-1 (Response Evaluation of Vosaroxin in Elderly AmL)
trial, a Phase 2 trial of single agent vosaroxin in previously untreated,
poor-risk elderly acute myeloid leukemia (AML) patients who are unlikely to
benefit from standard induction chemotherapy, in the November 17, 2014 Online
Version of Record of the British Journal of Haematology. The article, titled
"REVEAL-1, a phase 2 dose regimen optimization study of vosaroxin in older
poor-risk patients with previously untreated acute myeloid leukemia," is
available online at

"There remains an acute unmet medical need for new treatment options in AML,
including patients 60 years of age and older who are unlikely to benefit from
standard induction chemotherapy," stated Farhad Ravandi, M.D., Professor of
Medicine, Department of Leukemia, University of Texas MD Anderson Cancer
Center, and an author of the publication. "Vosaroxin is active and well
tolerated in this population, both as a single agent, as seen in the REVEAL-1
study, and in combination with decitabine, as seen in an ongoing MD Anderson
Cancer Center-sponsored study. Vosaroxin's activity in AML is further
highlighted in the recent outcome of the randomized, double-blind,
placebo-controlled Phase 3 VALOR trial, which looks at combination therapy
with cytarabine in the relapsed and refractory settings. In their totality,
these data suggest an important role for vosaroxin in the treatment of AML."

The REVEAL-1 study evaluated single-agent vosaroxin in patients ≥60 years of
age (n=113) with previously untreated unfavorable prognosis AML. Dose regimen
optimization was explored in sequential cohorts (A: 72 mg/m^2 on days 1, 8,
15; B: 72 mg/m^2 on days 1, 8; C: 72 mg/m^2 or 90 mg/m^2 on days 1, 4). The
primary efficacy endpoint was combined complete remission rate (complete
remission [CR] plus CR with incomplete platelet recovery [CRp]). The median
age in the study was 75 years and most patients (82%) had 2 or more risk
factors (age ≥ 70, antecedent hematologic disease [AHD], ECOG PS=2, or
intermediate/unfavorable cytogenetics).

Common (>20%) grade ≥3 adverse events were thrombocytopenia, febrile
neutropenia, anemia, neutropenia, sepsis, pneumonia, stomatitis, and
hypokalemia. Overall CR and CR/CRp rates were 29% and 32%; median overall
survival (OS) was 7.0 months; 1-year OS was 34%. Schedule C (72 mg/m^2) had
the most favorable balance of safety and efficacy, with faster hematologic
recovery (median 27 days) and lowest incidence of aggregate sepsis (24%) and
30-day (7%) and 60-day (17%) all-cause mortality. At this dose and schedule,
CR and CR/CRp rates were 31% and 35%, median OS was 7.7 months, and 1-year OS
was 38%.

"Publication of these data in the British Journal of Haematology further
support our goal of establishing vosaroxin as a new standard of care in AML,"
said Adam Craig, Chief Medical Officer of Sunesis. "Given ongoing demographic
shifts in the U.S. and other major territories, the challenge of treating AML
in older adults will continue to grow, underscoring a need for new treatment
options. We look forward to building on these data through further
investigator-sponsored studies and, with the outcome of VALOR in relapsed or
refractory AML, progressing towards initial regulatory approval."

As recently announced, based on results of the VALOR trial, Sunesis has
commenced a marketing authorization application (MAA) with the European
Medicines Agency (EMA) and plans to meet with the U.S. Food and Drug
Administration to determine the appropriate regulatory path forward for
vosaroxin in the treatment of relapsed or refractory AML.

Posted-In: News Press Releases


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