Synta Announces Ganetespib Program Updates
First Patient Enrolled in Phase 2 Portion of GANNET53 Study of Ganetespib in Ovarian Cancer
Phase 2 GALAXY-1 Trial of Ganetespib in NSCLC Published in Annals of Oncology
The Company announced today that the first patient has been enrolled in
the Phase 2 portion of the GANNET53 study, a randomized, pan-European
study evaluating the combination of ganetespib and paclitaxel vs.
paclitaxel alone in over 200 patients with metastatic, predominantly p53
mutant, platinum-resistant ovarian cancer. Enrollment in the Phase 2
portion follows the successful completion of Phase 1, the results of
which were recently presented at the 2015
“The Phase 1 portion of GANNET53 has established the feasibility and
tolerability of combining ganetespib and paclitaxel, and we eagerly look
forward to the enrollment of, and results from the randomized Phase 2
portion of this trial.” said Professor
The Company also announced today that results from the Phase 2 GALAXY-1 trial, a global, randomized, multi-center study designed to identify the patients with advanced non-small cell lung cancer (NSCLC) most likely to benefit from second-line treatment with ganetespib in combination with docetaxel versus docetaxel alone, have been published in the journal Annals of Oncology. As previously announced, a pre-specified stratification factor analysis demonstrated that patients diagnosed with advanced non-small cell lung adenocarcinoma more than six months prior to study entry derived the most benefit from combination treatment, leading to the selection of this population for the ongoing Phase 3 GALAXY-2 trial. Based on current projections and statistical assumptions, the first interim overall survival (OS) analysis of GALAXY-2 is on track to occur in the second half of 2015, and the second interim and final OS analyses will be conducted in 2016. The GALAXY-1 publication is available online here.
“We are pleased to see the GALAXY-1 findings published in the Annals
of Oncology and look forward to understanding how outcomes from this
trial translate to the ongoing, pivotal Phase 3 GALAXY-2 trial,” said
Dr.
“We remain highly encouraged by the progress of the ganetespib program
across a broad spectrum of malignancies and grateful to our
collaborating investigators for their strong, ongoing support for what
is today the most advanced, next generation inhibitor of Hsp90,” said
About Ganetespib
Ganetespib, an investigational drug candidate, is a selective inhibitor
of heat shock protein 90 (Hsp90), a molecular chaperone which controls
the folding and activation of a number of client proteins that drive
tumor development and progression. Many solid and hematologic tumors are
dependent on Hsp90 client proteins including proteins involved in
“oncogene addiction” (ALK, HER2, mutant BRAF and EGFR, androgen
receptor, estrogen receptor, and JAK2); proteins involved in resistance
to chemotherapy and radiation therapy (ATR, BCL2, BRCA1/2, CDK1/4, CHK1,
survivin, and WEE1); proteins involved in angiogenesis (HIF-1alpha,
VEGFR, PDGFR, and VEGF); and proteins involved in metastasis (MET, RAF,
AKT, MMPs, HIF-1alpha, and IGF-1R). In preclinical models, inhibition of
Hsp90 by ganetespib results in the inactivation, destabilization, and
eventual degradation of these cancer-promoting proteins. Ganetespib is
being evaluated in trials in lung cancer, breast cancer, and other tumor
types. The most common adverse event seen to date has been transient,
mild or moderate diarrhea, which has been manageable with standard
supportive care. Information on these trials can be found at www.clinicaltrials.gov.
Ganetespib has received Fast Track designation from
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 clinical trials including the pivotal GALAXY-2 Phase 3 trial in non-small cell lung cancer. 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.
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