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Synta Announces Initiation Of I-SPY 2 TRIAL Of Ganetespib In Breast Cancer

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Synta Pharmaceuticals Corp. (NASDAQ: SNTA) today announced the initiation of the I-SPY 2 TRIAL (Investigation of Serial Studies to Predict Your Therapeutic Response with Imaging And moLecular Analysis 2) arm evaluating ganetespib, the Company's Hsp90 inhibitor, as a neoadjuvant therapy for patients with breast cancer. I-SPY 2 is a standing Phase 2 randomized, controlled, multicenter trial for women with newly diagnosed, locally advanced breast cancer (Stage 2 or higher) that is designed to test whether adding investigational drugs to standard chemotherapy is better than standard chemotherapy alone in the neoadjuvant setting. I-SPY 2 is conducted by a consortium that brings together the Food and Drug Administration (FDA), National Cancer Institute (NCI), pharmaceutical companies, leading academic medical centers, and patient advocacy groups under its umbrella. The trial is sponsored by QuantumLeap Healthcare Collaborative, a 501(c)(3) non-profit organization dedicated to accelerating healthcare solutions, and shares a unique partnership with the Foundation for the National Institutes of Health Biomarkers Consortium.

The I-SPY 2 TRIAL employs a unique adaptive trial design to match experimental therapies with patients. Genetic or biological markers (“biomarkers”) from individual patients' tumors are used to screen promising new treatments, identifying which treatments are most effective in specific patient subgroups. Regimens that have a high Bayesian predictive probability of showing superiority in a 300 patient phase 3 confirmatory trial in at least one of 10 predefined signatures may “graduate” from I-SPY 2. A regimen can graduate early and at any time after having 60 patients assigned to it, and exits the trial after a maximum of 120 patients. This high efficacy bar and rapid turnaround time allows the trial to identify the right drug for the right patient in the most expeditious fashion.

Ganetespib will initially be available to patients with HER2 negative disease, with the intent to expand its eligibility to all breast cancer subtypes, including HER2 positive after safety testing with trastuzumab is completed.

“The I-SPY 2 trial offers us the opportunity to leverage the encouraging data we observed in earlier studies to further advance the development of ganetespib in breast cancer in a well-regarded consortium-sponsored trial,” said Anne Whitaker, Chief Executive Officer of Synta. “We are very pleased that ganetespib was selected for this innovative study, which is redefining how promising investigational compounds are rapidly evaluated as potential new treatments for breast cancer. We continue to support this and several other randomized investigator-led studies of ganetespib in both solid and hematologic malignancies.”

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