Eli Lilly hassuffered a setback with the news that it has stopped a late-stage clinicaltrial of its investigational skin cancer drug tasisulam after 12 studyparticipants died.
The company hassuspended its global Phase III study evaluating tasisulam as a second-linetreatment for patients with unresectable or metastatic melanoma. Lilly, inconsultation with an independent data monitoring committee, has recommended a"full clinical hold," because of safety concerns. The trial sought tocompare tasisulam versus paclitaxel and enrolled more than 300 patients in 18countries; its primary endpoint is overall survival.
Now the company isgoing to see whether the 12 deaths are in any way related to treatment with tasisulam.Richard Gaynor, head of oncology productdevelopment and medical affairs for Lilly, said “we are thoroughly reviewingthe clinical trial data to understand what modifications to the study protocolor 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 acuteleukaemia. The firm added that these studies are not being modified because thedosing of tasisulam is different but it is “closely evaluating patient safety within these trials on anongoing basis”.
Tasisulam was grantedorphan drug status for stage 2b-IV melanoma by the US Food and DrugAdministration in late 2009.