COPENHAGEN, Denmark--Bayer’s got the data it thinks it needs to snag cancer med Stivarga a second-line liver-cancer nod. If it does, the German drugmaker will be able to offer its blockbuster Nexavar and newer Stivarga as a one-two punch against the tough disease.
That would be a unique position for Bayer among its oncology rivals, and Stivarga put up numbers Saturday that could help it get there. The drug topped placebo in a Phase III trial, cutting down the risk of death by 37% in patients with hepatocellular carcinoma whose disease had progressed while taking Bayer’s Nexavar, the company announced at the ESMO 2016 Congress.
Those data make Stivarga the first drug to show an overall survival advantage in second-line unresectable liver cancer, Bayer said. The med delivered a median overall survival of 10.6 months, compared with 7.8 months in placebo patients--an improvement of 2.8 months.
That’s a big opportunity on its own, Robert LaCaze, the German drugmaker’s head of oncology, told FiercePharma at ESMO. Liver cancer is the second-largest killer among cancer patients, with more than 600,000 patients per year succumbing to the disease.
But in Nexavar, Bayer also has the only drug to show an overall survival advantage in previously untreated patients--and it’s hoping the one-two punch of Nexavar first, and Stivarga next, can help keep the company in the lead no matter what competitors come its way in the future.
“We know that there are other drugs being studied in this area, but those would be one-off approvals--front line, second line--but not necessarily this continuum approach that we could actually offer physicians as they think about the totality of treatments for the patients,” LaCaze said.
Of course, that doesn’t mean the Leverkeusen-based company is stopping Stivarga’s development there. It’s also exploring further opportunities for the med--one of 5 new launch products Bayer now expects to combine for more than €10 billion in peak sales--in colorectal cancer, the field in which it won its first-ever approval. Third-party investigators are studying the product in a range of tumor types.
For now, though, continuing to drive the opportunity in the colorectal market--along with preparing for a potential Stivarga HCC launch--are going to be Bayer’s “main focus” with the med, LaCaze said.
And Bayer does have some ground to recover with Stivarga. The drug's sales were down 16% for the first half of 2016, to €134 million from €163 million. Bayer cited "increased competition" for the decline.
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