Eli Lilly and Company announced today that it has suspended its global Phase III study evaluating tasisulam, an investigational, small-molecule anti-cancer compound, 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.
Lilly notified regulatory agencies and contacted all trial investigators to provide details on how to manage individuals enrolled in the trial.
"We are thoroughly reviewing the clinical trial data to understand what modifications to the study protocol or dosing would be needed to improve patient safety on this trial," said Richard Gaynor, M.D., vice president, oncology product development and medical affairs for Lilly.
Lilly continues to develop tasisulam as 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.
"We remain committed to Lilly Oncology's active fight against cancer, especially for patients facing cancers where the need for new treatments is especially great," added Gaynor.
The Phase III 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 was granted orphan drug status for stage 2b-IV melanoma by the U.S. Food and Drug Administration in late 2009.
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