Synta Pharmaceuticals Corp. (NASDAQ: SNTA), a biopharmaceutical company focused on discovering, developing, and commercializing small molecule drugs to treat severe medical conditions, today announced that it was expanding its Phase 2 clinical trial of STA-9090 in patients with Stage IIIB and Stage IV non-small cell lung cancer (NSCLC) from up to 69 patients to up to 146 patients based on encouraging activity observed in the first stage of the two stage clinical trial. STA-9090 is a potent, second-generation, small-molecule Hsp90 inhibitor, with a chemical structure unrelated to the first-generation, ansamycin family of Hsp90 inhibitors (e.g., 17-AAG or IPI-504).
"This NSCLC trial is enrolling patients into cohorts defined by the mutational status of key genes in order to identify cancer types especially responsive to STA-9090," said Vojo Vukovic, M.D., Ph.D., Senior Vice President and Chief Medical Officer, Synta Pharmaceuticals. "In the first stage of this trial we have seen exactly that; patients with EGFR and KRAS wild type, representing over 70% of all NSCLC, have shown a high disease control rate, over 70%. This early signal, combined with the objective responses seen following treatment with STA-9090, is very encouraging, particularly as the patients have been heavily pretreated and are refractory to many standard of care drugs. Also encouraging is that STA-9090 continues to be well tolerated at the 200mg/m2 once-weekly schedule, without the serious hepatic or ocular toxicities observed with other Hsp90 inhibitors. Based on these findings, we worked closely with investigators, modified the protocol, and expanded the trial in order to confirm and further characterize the observed activity in this group of patients. We expect to report on additional results from this trial, as well as plans for future trials in lung cancer, later this year or early next year."
Synta also announced that the Phase 2 trial will allow for the first focused evaluation of STA-9090 combination therapy in NSCLC. An additional cohort was created to allow certain patients to receive treatment with both STA-9090 and docetaxel. Clinical and preclinical results provide a strong rationale for combining taxanes and Hsp90 inhibitors, with the potential for synergistic activity.