Eli Lilly's key franchise drug ramucirumab flops in PhIII liver cancer study

Lilly ($LLY) has hit another setback in its effort to expand the market range for its key cancer drug ramucirumab, recently approved as Cyramza for stomach cancer.

Investigators say that the drug failed to hit the goal line for overall survival among liver cancer patients. Lilly, ever optimistic about its chances in the clinic, highlighted a trend in OS in favor of the drug and also noted some positive signs of efficacy in subpopulations.

"Although the REACH study did not achieve statistical significance for survival, we are encouraged by the efficacy seen overall, especially in specific subpopulations. We plan to discuss these results with regulatory authorities," said Richard Gaynor, M.D., senior vice president, product development and medical affairs for Lilly Oncology.

Ramucirumab has had a series of ups and downs in the clinic. The drug failed a big breast cancer study, setting up a roadblock for the drug in a key market. It also recently delivered a marginal benefit for patients suffering from advanced non-small cell lung cancer, reducing the risk of death by 14% and setting it up as a likely candidate for second-line use.

This latest failure highlights a long drought of major new approvals at Lilly, which was only broken with ramucirumab's OK at the FDA. Lilly's numbers have been hit hard by patent losses on its top products, opening the door to generic competition that has eroded earnings and placed the company in a must-win position in the clinic.

Lilly CEO John Lechleiter promised investors that the company will see "several" new approvals each year for the next few years. But it needs more than a slate of approvals to reverse the effects of a long string of trial failures. It needs major new drugs that can command blockbuster sales. Its top drug prospect in the late-stage pipeline is now dulaglutide, though Lilly will soon be forced to detail new data that shows the diabetes drug failed to beat out Novo's Victoza on reducing weight among patients, possibly limiting its market appeal following a likely approval.

- here's the release

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