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Synta Presents Results for STA-4783 in Metastatic Melanoma Showing,Improvement in Overall Survival

rolled trials for DTIC were 5.6, 6.4, 6.3, and 7.8 months respectively (2). A meta-analysis of over 1,300 patients with metastatic melanoma who received a variety of treatments showed a median overall survival time of 6.4 months (3). Other randomized trials have consistently shown a median survival time between six and nine months regardless of treatment (1).

STA-4783 was generally well-tolerated in this study; side effects were predictable and were generally comparable to treatment with paclitaxel alone. Neutropenia occurred more commonly in the STA-4783 plus paclitaxel group compared to the paclitaxel alone group, but this was manageable and reversible. Although paresthesias occurred more commonly in the STA-4783 plus paclitaxel group, the incidence of severe events of this type was low and comparable between groups. The most common adverse events in the STA-4783 plus paclitaxel group included fatigue, alopecia, constipation, nausea, hypoaesthesia, arthralgia, insomnia, diarrhea, and anemia.

About the Phase 2b Trial

The blinded, randomized Phase 2b clinical trial was conducted in 21 centers in the United States and compared patients treated with STA-4783 plus paclitaxel (N=53) vs. patients treated with paclitaxel alone (N=28). In the Phase 2b trial, patients who received STA-4783 plus paclitaxel showed a doubling of median progression free survival (PFS), the primary endpoint of the study, compared to those patients who received paclitaxel alone (3.68 months vs. 1.84 months, p=0.035). In addition, the PFS at six months, considered a useful predictor of overall survival, more than doubled (35% vs. 15%), and the response rate more than tripled (15% vs. 4%).

About STA-4783

STA-4783 is a novel, injectable, small molecule investigational drug candidate that induces a potent oxidative stress response in cancer cells, driving programmed cell death and enhancing the activity of anti-cancer agents that act through the mitochondrial apopto
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