Phase 3 study of tasisulam suspended for the treatment of advanced metastatic melanoma

Eli Lilly announced that it has suspended its global Phase 3 study evaluating tasisulam as a second-line treatment for those with unresectable or metastatic melanoma. Lilly, in consultation with an independent data monitoring committee, recommended a "full clinical hold," because of safety concerns.  A full clinical hold ensures that no new or existing patients in the trial receive additional doses of the compound, allowing researchers the time to fully analyze existing data. The trial sought to compare the efficacy, safety and tolerability of tasisulam versus paclitaxel, as a second-line treatment for those with metastatic melanoma.  The study enrolled more than 300 patients in 18 countries.  The primary endpoint of this study is overall survival.

Tasisulam, an investigational, small-molecule anti-cancer compound, is part of an extensive clinical development program across a wide range of tumors, including soft tissue sarcoma, breast, ovarian and renal cancers, as well as non-small cell lung cancer and acute leukemia. At this time, these trials continue without modification because the dosing of tasisulam is different. Lilly is closely evaluating patient safety within these trials on an ongoing basis.

For more information call (800) LillyRx or visit www.LillyOncology.com.