Bristol-Myers' Yervoy hopes snag on flubbed prostate cancer trial

Bristol-Myers Squibb ($BMY) has hit a speed bump in the road to new uses for its melanoma treatment Yervoy. The drug fell short in a prostate cancer trial by failing to significantly extend patients' lives. But some of the study data could signal good news from another ongoing test of Yervoy in prostate cancer, Reuters reports.

The study unveiled today looked at Yervoy treatment in patients who failed on hormone-lowering therapy and standard chemo with docetaxel. Patients were given doses of radiation and then a round of Yervoy or placebo. Yervoy patients lived an average of 11.2 months, compared with 10 months for patients on placebo, the study abstract reports.

More details will be presented at the European Cancer Congress later this month. But in two respects, the failure could have a silver lining. Citi analyst Andrew Baum pointed out that the overall survival benefit missed statistical significance only narrowly. And as Reuters points out, the drug did appear to work better in men in earlier stages of the disease--and that's a population Bristol-Myers is studying in a prostate cancer trial due for completion in 2015.

Prostate cancer is an increasingly tough market. There's Johnson & Johnson's ($JNJ) Zytiga, which stormed out of the gate on FDA approval in 2011. It brought in $961 million in 2012, its first full year on the market, and racked up another $739 million for the first half of 2013. In December, it won an FDA nod for use before chemotherapy, based on a trial that found patients lived about 5 months longer with Zytiga, at a median of 35.3 months, compared with 30.1 months with placebo.

Late last year, a much-anticipated alternative from Medivation ($MDVN), Xtandi, joined the fray. Its ability to extend men's lives in a clinical trial was impressive; Xtandi patients lived for a median of 18.4 months, compared with 13.6 months in placebo patients. Through the second quarter of 2013, sales amounted to $157 million. Zytiga will likely break the blockbuster barrier this year, and Xtandi is widely expected to follow.

Both Zytiga and Xtandi work to thwart prostate cancer by cutting off its fuel supply (though they do so in different ways). Yervoy works by stimulating the body's immune system to fight cancer. Its approval in melanoma marked the first new survival-boosting therapy in decades. Yervoy quickly caught on in that market, with $360 million in sales for its first 9 months on the market. Last year it brought in $706 million.

Besides ongoing study in prostate cancer, Bristol-Myers is testing Yervoy in small-cell lung cancer, non-small cell lung cancer, and new melanoma indications. A trial pairing Yervoy and Roche's ($RHHBY) targeted melanoma drug Zelboraf was stopped earlier this year after signs of liver toxicity developed in some patients.

- see the release from Bristol-Myers
- read the news from Reuters

Special Reports: Top 10 Best-Selling Cancer Drugs | Top 20 Orphan Drugs by 2018 - Yervoy

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