Onyx, Bayer’s Next Cancer Drug Shows Slim Survival Edge

Xconomy San Francisco — 

Bayer and Onyx Pharmaceuticals looked like they hit gold last fall, when a study of 760 patients showed that one of their new cancer drugs was able to help patients with colorectal cancer live longer.

Today, researchers got the first glimpse at the detailed results, and while it’s encouraging news for the companies and for patients, it’s not exactly something to shout about from the rooftops.

The new drug from Bayer and South San Francisco-based Onyx (NASDAQ: ONXX) showed that it helped patients live a median time of 6.4 months with colorectal cancer that had spread through the body, compared with a median of five months for those in the placebo group. The new drug, regorafenib, had significant side effects like almost all cancer drugs. About 17 percent of patients had moderate to severe skin reactions on their hands and feet, while 15 percent had significant fatigue, and 8 percent had significant diarrhea, researchers said today at the American Society of Clinical Oncology’s gastrointestinal cancer symposium in San Francisco. There was nothing new or unexpected in the drug’s safety profile, scientists said.

Onyx and Bayer have long worked together to co-market sorafenib (Nexavar) as a treatment for kidney and liver cancers, but the relationship was frayed recently by litigation over who owns the second, related compound. The companies settled that dispute in October, in an arrangement where Onyx got a $160 million one-time payment and will get a 20 percent royalty on worldwide sales of the new drug. That royalty stream suddenly looked valuable two weeks later when an independent monitoring committee looked at the data of the ongoing study known as Correct, saw the survival edge, and recommended the study be halted earlier than planned so all patients could get the experimental medicine.

Onyx Pharmaceuticals CEO Tony Coles

Analysts are now projecting regorafenib will be a billion-dollar seller, which could throw off hundreds of millions in annual revenue to Onyx. If the drug wins regulatory approval, it could offer colorectal cancer patients a new option beyond existing drugs like Eli Lilly’s cetuximab (Erbitux), Roche’s bevacizumab (Avastin), and Amgen’s panitumumab (Vectibix). About 52,000 patients in the U.S. are expected to die this year from colorectal cancer, according to the American Cancer Society.

“We’ve shown an improvement in overall survival, which we think is really terrific because these are third and fourth-line metastatic patients who have gone through almost all other available options,” Onyx CEO Tony Coles said in an interview last week at the JP Morgan Healthcare Conference, before the details were released.

Bayer said in a statement today that it plans to seek regulatory approval later this year for clearance to start selling the drug for patients with colorectal cancer that has spread.

Colorectal cancer isn’t the only place where Bayer and Onyx see the new drug potentially being used. The companies are expecting to see results from a pivotal study of 350 patients with gastrointestinal stromal tumors (GIST) before the end of March, Coles says. “Between the colorectal cancer data, and the GIST data to come, regorafenib is clearly on the scene,” Coles says. “The two companies are working together to pursue other indications.”

Few analysts last fall were counting on any revenue at all from regorafenib, so it was a surprising and transforming piece of news for the company. As Coles put it, “we are in position to go from one product for two tumors (Nexavar) to potentially three products with strong data or [an FDA clearance] for seven different cancers by the end of this year,” Coles says. The other drug besides Nexavar and regorafenib is known as carfilzomib, which is being reviewed by the FDA as a new treatment for multiple myeloma.

“When you see that kind of momentum in the business in such a short period of time, it’s unrivaled,” Coles says. “We think the future is very bright.”

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