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Synta Announces Presentation of Results from an Investigator-Sponsored Phase 1 Trial of Ganetespib in HER2+ Metastatic Breast Cancer

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Synta Pharmaceuticals Corp. (NASDAQ: SNTA) today announced presentation of preliminary results from an investigator-sponsored phase 1 trial, designed to evaluate ganetespib in combination with paclitaxel and trastuzumab in women with HER2+ metastatic breast cancer (MBC) refractory to other HER2 inhibitors. The results are being presented during a poster session at the 2014 San Antonio Breast Cancer Symposium in San Antonio, Texas.

The phase 1 trial, conducted by physicians at New York University Langone Medical Center and Memorial Sloan Kettering Cancer Center, enrolled six heavily pretreated patients who received prior to entering the trial a median of 3.5 anti-HER2 treatments in the metastatic setting (range 3-4), including trastuzumab, pertuzumab, and ado-trastuzumab emtansine (T-DM1).

Of the five patients evaluable for efficacy, partial tumor response was observed in one patient who remains on study, and four patients achieved stable disease ranging in duration from 11 to 29 weeks. Median Progression Free Survival was 19.4 weeks and the observed Clinical Benefit Rate (proportion of patients achieving objective response or stable disease greater than 24 weeks) was 60%.

Consistent with previously reported results for ganetespib, diarrhea, and fatigue were the most common adverse events associated with the combination treatment and were mostly Grade 1 or 2 in severity.

“Ganetespib targets the heat shock protein 90 (HSP90), a molecular chaperone critical to the activity of multiple oncoproteins of which HER2 is one of the most sensitive to HSP90 inhibition,” said Dr. Komal Jhaveri, New York University Langone Medical Hospital, Principal Investigator of the trial. “We are encouraged by the ganetespib combination safety and preliminary activity observed in this phase 1 trial in HER2 patients who are refractory to currently available HER2 therapies.”

“Our findings showing safety and activity of ganetespib combination therapy in refractory HER2+ breast cancer are consistent with ganetespib single agent activity demonstrated previously in heavily pretreated HER2+ patients as well as in the first-line setting (ENCHANT trial),” said Shanu Modi, Memorial Sloan-Kettering Cancer Center, Co-Investigator of the trial. “We therefore plan to further evaluate ganetespib in combination with trastuzumab and pertuzumab for HER2+ MBC.”

Dr. Vojo Vukovic, Chief Medical Officer, Synta added: “We look forward to working with the investigators on ganetespib combination trials in patients with metastatic breast cancer as well as the ongoing I-SPY 2 trial in the neoadjuvant setting.”

A copy of this poster presentation may be found in the Ganetespib Presentations section of the Company's website, www.syntapharma.com.

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