Bayer bolsters blockbuster case for regorafenib with new PhIII data
Bayer has racked up a fresh set of preliminary late-stage data that will bolster its plans to market regorafenib for a range of cancers. The treatment, which bears a striking resemblance to sorafenib (Nexavar), registered a successful response for gastrointestinal stromal tumors in Phase III, adding to the positive data already gathered on colorectal cancer.
Just a few months ago Bayer agreed to pay Onyx ($ONXX) $160 million and a hefty royalty slice on regorafenib to settle the biotech's claim that Bayer scientists had secretly created an analog closely matched to sorafenib, their blockbuster cancer medication. Now that that dispute has been replaced by a partnership, Bayer is eager to move ahead on a new drug program that promises to deliver more than a billion dollars a year in new revenue. Bayer has set its sights on applying for an approval on colorectal cancer with plans to expand its use for other cancers.
In this latest trial Dana-Farber's George Demetri studied regorafenib in advanced cancer patients who weren't responding to existing medications. Bayer says the treatment hit its primary endpoint on progression-free survival. The data will be detailed at an upcoming scientific meeting.
About 200 patients were enrolled in the study, with a 2-to-1 mix getting 160 mg of regorafenib daily, three weeks on and one week off. And patients in the control arm whose disease progressed were offered regorafenib.
"GIST is a difficult disease to treat. Patients treated with currently available therapies have a high likelihood that their disease will progress, and there are no remaining treatment options for those patients whose prior therapies have failed," said Ted W. Love, the EVP for R&D at Onyx. "These clinical data will show regorafenib's activity in patients with previously treated GIST."
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