Synta Pharmaceuticals Corp. (NASDAQ: SNTA) today provided clinical updates and reported financial results for the second quarter ended June 30, 2013.
Our lead clinical candidate is ganetespib, a selective inhibitor of the Hsp90 chaperone protein, which is being evaluated in over 25 clinical trials that have enrolled over a thousand patients to date, including our GALAXY program in lung cancer and our ENCHANT program in breast cancer.
The GALAXY program in lung cancerAt the 2013 meeting of the American Society of Clinical Oncology (ASCO), investigators presented results from an interim analysis evaluating 252 adenocarcinoma patients treated in our ongoing GALAXY-1 Phase 2b/3 trial evaluating ganetespib in combination with docetaxel vs. docetaxel alone for the second-line treatment of advanced non-small cell lung adenocarcinoma. Results included:
- In the all-adenocarcinoma population (N=252), the ganetespib combination arm showed improved overall survival, progression-free survival, and response rate compared to the docetaxel arm.
- A statistical interaction test showed that one of the four prospectively-defined stratification factors was strongly predictive of ganetespib activity (p=0.006). Patients with "chemo-sensitive" disease (N=176; 70%) derived substantially greater benefit from ganetespib than patients with "chemo-refractory" disease (N=76; 30%).
- In the chemo-sensitive population, defined as time since diagnosis of advanced disease greater than six months, median overall survival increased from 6.4 to 10.7 months, and the Hazard ratio was 0.61 (1-sided p=0.009), corresponding to a 39% reduction in the risk of death.
- The rate of new lesion formation decreased by 50% in patients treated with ganetespib (Hazard ratio 0.50, p=0.005). This observation is consistent with preclinical and clinical results suggesting ganetespib inhibits the biological pathways that drive angiogenesis (new blood vessel formation) and metastasis (the spread of tumors) in cancer cells.
- Transient, mild-to-moderate diarrhea, manageable with OTC medication, was the most common adverse event observed with ganetespib, consistent with observations from other clinical trials. Other adverse events increased relative to control included mild to moderate anemia and fatigue, as well as an increase in the number of cases of febrile neutropenia.