In its fourth major clinical setback in as many months, Eli Lilly ($LLY) has suspended all treatments in a late-stage trial of its melanoma drug tasisulam after recording a dozen deaths in the study. The move to halt therapy for all patients came after investigators reviewed a safety issue--which was not revealed by Lilly. But Bloomberg reports that a dozen patients had died in the study, quoting a spokesperson for the pharma giant who noted that the deaths may be related to the treatment.
"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," Dr. Richard Gaynor, vice president of oncology product development and medical affairs for Lilly, said in a statement. The drug was being tested on patients whose melanoma had spread and who weren't responding to currently available therapies.
The suspension marks yet another black eye for the R&D group at Lilly. The teplizumab diabetes program blew up in October, just a day before the FDA handed Lilly and its partners another big delay for Bydureon. Those events followed a decision in August to suspend treatments of semagacesta for Alzheimer's after patients' conditions grew worse. Tasisulam is being tested on a range of cancers including non-small cell lung cancer as well as ovarian and renal cancer. Those trials will continue, the company said, as it was using a different dosage.
Lilly's string of clinical mishaps has kept the spotlight focused directly on CEO John Lechleiter's insistence on relying on the company's pipeline and a select number of biotech pacts to drive the new products it must have to make up for the billions in revenue it will soon lose to generic competitors after Zyprexa loses patent protection next year. Cymbalta, which earns $3 billion, loses its exclusive status in 2013. A number of analysts insist that as Lilly's late-stage programs falter, the need for a significant M&A deal grows.