|FiercePharma file photo|
Bayer and Onyx Pharmaceuticals' Nexavar has seen a lot of success as a liver cancer treatment, topping market threats from the likes of Bristol-Myers Squibb ($BMY) and Pfizer ($PFE) in head-to-head trials on its way to blockbuster status. But as an adjuvant therapy for liver cancer? It could be awhile--if ever. On Tuesday, the drug missed its target in a Phase III trial, failing to meet the study's main goal of improving recurrence-free survival.
The German pharma and Onyx, now a subsidiary of Amgen ($AMGN), tested the tablets in about 1,100 patients who had no detectable disease after surgical resection or local ablation, the company said. But on that front, Nexavar--already approved to treat liver cancer that cannot be surgically removed--didn't beat out a placebo.
"While the primary endpoint of this adjuvant trial was not met, Bayer and Onyx remain dedicated to ongoing research in all stages of liver cancer," Dr. Pamela Cyrus, VP and head of U.S. Medical Affairs for Bayer HealthCare's pharma division, said in a statement.
The companies have faced their share of struggles when it comes to studying the drug in new patient pools. In May of 2012, Nexavar failed to improve overall survival in a Phase III lung cancer trial; at one point, the company had projected that the lung cancer indication could more than double the drug's sales.
But that's not to say Nexavar's makers have had no success expanding its market. The med, which generated €771 million ($1.06 billion) for Bayer alone in 2013, counts certain types of kidney cancer among its FDA-approved indications; more recently, the agency green-lighted the drug as a treatment for some patients with advanced thyroid cancer.
And Bayer and Onyx are not stopping there: The pair is currently testing Nexavar in breast cancer trials as well as studying it as an adjuvant treatment in kidney cancer patients. Analysts expect it to reach $1.46 billion in sales by 2018.
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