Patient deaths halt Lilly cancer trial
pharmafile | December 15, 2010 | News story | Research and Development | Eli Lilly, lilly, melanoma, skin cancer, tasisulam
Lilly has been forced to halt phase III trials of its melanoma candidate tasisulam due to serious safety concerns over the drug.
An independent data monitoring committee recommended a “full clinical hold” after 12 people died during the study. Lilly is now looking into whether this was directly related to use of its drug.
Lilly was studying the drug on 300 patients as a treatment for those whose skin cancer had spread and who did not benefit from a first line treatment.
Richard Gaynor, VP 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.”
The phase III trial sought to compare the efficacy, safety and tolerability of tasisulam versus chemotherapy agent paclitaxel, as a second line treatment for those with metastatic melanoma, with the primary endpoint being overall survival.
Melanoma is the deadliest form of skin cancer and has few effective treatments.
Bristol-Myers Squibb’s melanoma candidate ipilimumab had been put on FDA priority review in August but will now have to wait until next March for a final decision after the regulator asked for more information.
Roche has also recently released positive mid-stage trial data for its RG7204, an investigational, first-in-class molecule designed to selectively inhibit a cancer-causing, mutated form of the BRAF protein found in around half of all melanoma patients.
The clinical hold on Lilly’s tasisulam marks the third time this year the US-based pharma has seen a drug fail in late-stage clinical trials.
In October, Lilly suspended its phase III diabetes drug Protégé and in August was forced to halt its key Alzheimer’s drug semagacestat after it was found to worsen the condition.
Lilly said it would continue to develop tasisulam as part of an “extensive clinical development programme” 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 leukemia.
For the time being these trials will continue without modification because the dosing of tasisulam is different, Lilly said, adding it will closely evaluate patient safety within these trials on “an ongoing basis”.
Ben Adams
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