Synta Announces Termination for Futility of Ganetespib Phase 3 GALAXY-2 Trial in Lung Cancer
21 Ottobre 2015 - 1:30AM
Business Wire
Company to Host Conference Call on
Wednesday, October 21 at 8:00 AM ET
Synta Pharmaceuticals Corp. (NASDAQ: SNTA) today announced that
the Company has decided to terminate the Phase 3 GALAXY-2 trial of
ganetespib and docetaxel in the second-line treatment of patients
with advanced non-small cell lung adenocarcinoma. Based on the
review of a pre-planned interim analysis, the study’s Independent
Data Monitoring Committee (IDMC) concluded that the addition of
ganetespib to docetaxel is unlikely to demonstrate a statistically
significant improvement in the primary endpoint of overall survival
compared to docetaxel alone. The IDMC noted that the combination of
ganetespib and docetaxel was generally well tolerated in the study,
with an adverse event profile consistent with previous studies
combining these agents.
GALAXY-2 is a Phase 3 global, randomized, multi-center trial.
Synta continues to support enrollment in four additional large,
randomized, multi-center investigator-sponsored studies, including:
the GANNET53 trial of ganetespib and paclitaxel in ovarian cancer;
the AML LI-1 trial of ganetespib with low dose cytarabine (Ara-C)
in acute myeloid leukemia (AML) and high-risk myelodysplastic
syndrome (MDS); the AML18 trial of ganetespib with standard DA
(daunorubicin and Ara-C) in AML and high-risk MDS; and the I-SPY 2
TRIAL of ganetespib and standard chemotherapy in women with newly
diagnosed, locally advanced breast cancer.
“This disappointing outcome underscores the challenges of
treating lung cancer in the second-line setting and determining the
precise population for whom ganetespib may be most effective,” said
Chen Schor, President and Chief Executive Officer of Synta. “We
thank the patients, caregivers and investigators who participated
in GALAXY-2.”
Mr. Schor continued: “Despite the outcome of this trial, and
pending discussions with the relevant investigators, we will
continue to support ongoing investigator-sponsored studies while we
determine the appropriate path forward for ganetespib. We also look
forward to advancing candidates from our HDC platform into the
clinic. With the significant cash reserves we have in hand, our
pipeline, our scientific internal leadership and network of
advisors, we expect to undertake a comprehensive review of our
strategy going forward.”
Upon formal acceptance of the IDMC’s recommendation, Synta will
communicate with regulatory authorities, and will notify study
investigators that treatment with ganetespib should be discontinued
in the GALAXY-2 trial.
Conference call
Synta will host a conference call at 8:00 AM ET on Wednesday,
October 21st to discuss the outcome of the GALAXY-2 trial. The
conference call will be webcast live and can be accessed by logging
on to the “Investors” section of the Synta Pharmaceuticals website,
www.syntapharma.com, prior to the event.
The conference call can also be accessed by dialing (877)
715-8365 (U.S.) or (440) 996-5675 (International). For those unable
to join the live call, a replay will be available from 11:00 a.m.
ET on October 21 through 11:59 p.m. ET on October 28. To access the
replay, please dial (855) 859-2056 (U.S.) or (404) 537-3406
(International) and refer to conference ID 65923441.
About Synta Pharmaceuticals
Synta Pharmaceuticals Corp. is an innovative, agile
biopharmaceutical company focused on research, development and
commercialization of novel oncology medicines that have the
potential to change the lives of cancer patients. Synta’s lead
oncology drug candidate, ganetespib, a novel heat shock protein 90
(Hsp90) inhibitor, is currently being evaluated in several
investigator sponsored clinical trials including clinical trials in
acute myeloid leukemia (AML), ovarian cancer, breast cancer, and
other tumor types. Building on its extensive expertise in the
science of Hsp90, Synta also has a novel proprietary Hsp90
inhibitor Drug Conjugate (HDC) small molecule drug development
program. IND enabling studies have commenced for the first clinical
candidate from the HDC program, STA-12-8666, and preclinical
evaluation of additional HDC candidates is ongoing. For more
information, please visit www.syntapharma.com.
Safe Harbor Statement
This media release may contain forward-looking statements about
Synta Pharmaceuticals Corp. Such forward-looking statements can be
identified by the use of forward-looking terminology such as
"will", "would", "should", "expects", "anticipates", "intends",
"plans", "believes", "may", "estimates", "predicts", "projects", or
similar expressions intended to identify forward-looking
statements. Such statements, including statements relating to the
continuation of the ongoing investigator-sponsored studies of
ganetespib and the advancement of candidates from our HDC platform
toward the clinic, reflect Synta’s current views with respect to
future events and are based on assumptions and subject to risks and
uncertainties that could cause actual results to differ materially
from those expressed or implied by such forward-looking statements,
including those described in "Risk Factors" of our Form 10-K for
the year ended December 31, 2014 as filed with the Securities and
Exchange Commission. Synta undertakes no obligation to publicly
update forward-looking statements, whether because of new
information, future events or otherwise, except as required by
law.
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version on businesswire.com: http://www.businesswire.com/news/home/20151020006900/en/
Investors:Synta Pharmaceuticals Corp.Daniel Cole,
781-541-7250dcole@syntapharma.comorArgot PartnersAndrea Rabney or
Susie Kim, 212-600-1902andrea@argotpartners.comorMedia:Argot
PartnersEliza Schleifstein, 917-763-8106eliza@argotpartners.com
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