Bayer plots Stivarga expansion with new top-line data in hand


Bayer has pegged cancer drug Stivarga as one of 5 that’ll drive its future growth. And now, it has some new data in hand that could help it do just that.

Monday, the German pharma announced that a Phase III study in patients with unresectable liver cancer had met its primary endpoint. In 573 sufferers whose disease had progressed after treatment with Bayer blockbuster Nexavar, Stivarga produced a statistically significant improvement over placebo in extending overall survival.

The company plans to detail the safety and efficacy results from the trial at a scientific congress down the line, but meanwhile, it’s planning to submit the findings to regulatory authorities this year as the backbone for a label expansion.

A new indication could come up big for Stivarga, which is currently approved to treat metastatic colorectal cancer and metastatic gastrointestinal stromal tumors. Unresectable liver cancer--also known as hepatocellular carcinoma, or HCC--is the most common form of the disease, Bayer said in a statement, making up 70% to 85% of the 780,000 cases diagnosed worldwide each year.

And Bayer wouldn’t mind that at all. It’s expecting big things from its Big 5, which include Stivarga along with fellow cancer drug Xofigo; Xarelto, the next-gen anticoagulant it shares with Johnson & Johnson; Eylea, the hot-selling eye med it shares with New York’s Regeneron; and pulmonary arterial hypertension med Adempas.

Despite their contributions, though, the drugmaker has said it expects sales to increase by just a medium single-digit percentage for the year to pass €47 billion, a forecast that hit below the predictions of several analysts. But some industry-watchers think the Leverkeusen-based pharma may have kept expectations on the low side on purpose, giving brand-new CEO Werner Baumann a chance to find his footing.

- read Bayer's release 

Special Report: The top 15 pharma companies by 2014 revenue - Bayer

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