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礼来抗癌药物ramucirumab三期临床研究再遇滑铁卢

来源:生物谷 2014-06-11 23:36

2014年6月12日讯 /生物谷BIOON/ --礼来公司寄予厚望的抗癌药物ramucirumab(Cyramza)最近在一项治疗肝癌的三期临床研究中未能达到预定目标而宣告失败。不过公司研发负责人Richard Gaynor仍然对其充满信心,他表示尽管Cyramza未能达到预想目标,但在研究中发现Cyramza对特定基因型群体的疗效出乎意料的好。因此,下一步礼来公司将继续探讨Cyramza在这一方面发展的可能性。目前Cyramza已经被FDA批准用于治疗胃癌。但是在此之前,由于Cyramza治疗乳腺癌的研究同样失败,导致礼来公司失去癌症治疗的一个重要市场。因此,此次三期研究的不尽如人意对礼来公司无疑是雪上加霜。(生物谷Bioon.com)

详细英文报道:

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.

 

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