Lilly suspends melanoma trial after deaths

Eli Lilly has suffered a setback with the news that it has stopped a late-stage clinical trial of its investigational skin cancer drug tasisulam after 12 study participants died.

The company has suspended its global Phase III study evaluating tasisulam as a second-line treatment for patients with unresectable or metastatic melanoma. Lilly, in consultation with an independent data monitoring committee, has recommended a "full clinical hold," because of safety concerns. The trial sought to compare tasisulam versus paclitaxel and enrolled more than 300 patients in 18 countries; its primary endpoint is overall survival.  

Now the company is going to see whether the 12 deaths are in any way related to treatment with tasisulam. Richard Gaynor, head of oncology product development and medical affairs for Lilly, said “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”.

Lilly will continue to develop tasisulam “across a wide range of tumours”, including soft tissue sarcoma, breast, ovarian and renal cancers, as well as non-small cell lung cancer and acute leukaemia. The firm added that these studies are not being modified because the dosing of tasisulam is different but it is “closely evaluating patient safety within these trials on an ongoing basis”.

Tasisulam was granted orphan drug status for stage 2b-IV melanoma by the US Food and Drug Administration in late 2009.