SYNTA ANNOUNCES RESULTS FROM MELANOMA TRIAL

Synta Pharmaceuticals has released positive data from a Phase IIb study in metastatic melanoma for STA-4783, a first-in-class heat shock protein 70 (Hsp70) inducer that activates natural killer (NK) cell-mediated tumor killing. In the double-blind, randomized, controlled trial in patients with Stage IV disease, STA-4783 plus paclitaxel doubled progression-free survival, the primary study endpoint, compared with paclitaxel alone.

"Metastatic melanoma has proven resistant to many therapeutic approaches and pharmaceutical agents. To my knowledge, this study is the first in metastatic melanoma to demonstrate increased progression-free survival by a small molecule in a double-blind, randomized, controlled trial," said Steven O'Day, principal investigator for the study.

The study was conducted at 21 U.S. sites and enrolled 81 patients with Stage IV metastatic melanoma. Study participants were randomized in a 2-1 ratio to receive STA-4783 plus paclitaxel or paclitaxel alone, respectively. Patients were dosed intravenously once a week for three weeks, followed by one week off therapy, until disease progression. Based on the intent-to-treat analysis, median progression-free survival for patients receiving STA-4783 plus paclitaxel was 112 days versus 56 days for those receiving paclitaxel alone, a statistically significant difference that met the primary endpoint. STA-4783 was well-tolerated in the study, with adverse events typical of those expected for paclitaxel alone.