By Michael Fitzhugh
Safety concerns at Eli Lilly (LLY) convinced the company to suspend a late-stage trial of its investigational melanoma treatment, tasisulam, adding to a string of clinical disappointments for the company this year.
The Indianapolis-based company is developing tasisulam as a treatment for melanoma that has spread and has failed to adequately respond to first-line treatment. More than 300 people in 18 countries were enrolled in the trials.
While the setback won’t impact any of Lilly’s tests of tasisulam for use in treating other cancers, Lilly could have done without the bad news of another problematic late-stage drug candidate.
In October, the company said that its global late-stage trial of Alimta as a treatment for head and neck cancer, failed to meet its primary endpoint for overall survival. Then, later that same month, Lilly and MacroGenics decided to suspend a trial of teplizumab, an experimental monoclonal antibody that failed to adequately help people with type 1 diabetes.
In the case of tasisulam, Lilly issued an order called a clinical hold, putting an end to all further dosing in the trial. That edict was issued after Lilly scientists and members of an independent data monitoring committee uncovered safety concerns while analyzing trial data.
Lilly didn’t reveal the type or severity of the safety issues trial patients encountered. But there seems to be a possibility that the trial could be resumed with alterations.
“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,” says Richard Gaynor, Lilly’s vice president of oncology product development and medical affairs.
The late-stage trial sought to compare the efficacy, safety, and tolerability of tasisulam versus paclitaxel, as a second-line treatment for those with metastatic melanoma. The primary endpoint is overall survival.
Lilly is continuing to develop tasisulam for 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. Those trials continue without modification because the dosing of tasisulam is different, the company says.
Lilly, which during the next seven years faces the loss of patent protection on drugs that accounted for 74 percent of its 2009 sales, will likely feel additional pressure from the setback from critics calling for the company to make acquisitions to refill its pipeline of products. The company, which has vowed to innovate its way out of one of the steepest patent cliffs in the industry, has been a target of sharp criticism from Wall Street for its strategy.