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Lilly suspends cancer trial

Eli Lilly has halted a global phase III study of its experimental melanoma drug tasisulam due to safety concerns

Eli Lilly has halted a global phase III study of its experimental melanoma drug tasisulam due to safety concerns.

The drug, a small molecule that has been granted orphan status for the indication by the US Food and Drug Administration (FDA), was being tested against paclitaxel as a second-line treatment for unresectable or metastatic melanoma with the primary endpoint of overall survival.

Lilly did not specify the safety issues that had arisen, but the company said that an independent data monitoring committee had recommended a full clinical hold on the study, meaning that no new or existing patients in the trial will be given any further doses of the drug until an analysis of the existing data can be completed.

The company said the data review would focus on changes to the dosing of the drug to improve patient safety. In the meantime, studies of tasisulam in a range of other cancer indications - including soft tissue sarcoma; breast, ovarian and renal cancers; non-small cell lung cancer; and acute leukaemia –will continue because they use different dosing regimens than the suspended trial.

The phase III melanoma trial was comparing tasisulam to paclitaxel as a second-line treatment in more than 300 patients with metastatic melanoma at sites in 18 countries.

Earlier this year, Lilly released phase II data for the drug in unresectable or metastatic melanoma showing that of the 68 patients enrolled in the study, eight demonstrated partial response, 24 had stable disease (no progression after two cycles), 25 had progressive disease and 11 did not have their disease progression completely evaluated. The median progression-free survival was 2.6 months and the median overall survival was 9.6 months.

14th December 2010

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