Onyx Pharmaceuticals Steps Up Its Game

By Christin Melton
Published: Thursday, May 20, 2010
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The motto for Onyx Pharmaceuticals is “Changing the Way Cancer is Treated.” With a successful 2009 behind it and a busy 2010 ahead, Onyx is staying true to its word. Tony Coles, MD, MPH, took on the dual role of CEO and president of Onyx Pharmaceuticals in March 2008 and steered the company successfully through a worldwide recession. In each of the first three quarters of 2009, earnings exceeded 2008 levels; for the third quarter alone, Onyx reported a 36% growth in revenue.

Onyx has increased its investment in research and development and has several promising drugs in the pipeline. Topping this off, Zacks Investment Research praised Onyx’s acquisition of Proteolix last year “as a significant addition to Onyx’s cancer pipeline.” Proteolix is the maker of the novel drug carfilzomib, which has shown tremendous promise in several studies. In an interview with Oncology & Biotech News, Coles discussed Onyx’s ongoing success and outlined the company’s ambitious agenda for 2010.

Nexavar still golden

Nexavar is the main driver of Onyx’s current success. The FDA approved Nexavar (sorafenib) in 2005 for advanced renal cell carcinoma and in 2007 for hepatocellular carcinoma. It is now used in more than 80 countries. Onyx reported that sales of Nexavar grew 27% in the third quarter of 2009 compared with the third quarter of 2008. “We attribute the strong growth in Nexavar to the significantly unmet need that exists in liver cancer,” Coles said, noting that Nexavar had made inroads in several new markets recently. “We had several very important launches since 2008, notably in some of the European markets and, importantly, in some of the Asia-Pacific markets, where the incidence of liver cancer is highest.”

At the San Antonio Breast Cancer Symposium (SABCS) in December 2009, several studies indicated that Nexavar might have a promising future in other solid tumors. Jose Baselga, MD, an oncologist at Vall d’Hebron University Hospital in Barcelona, Spain, presented data that showed first- and second-line therapy with Nexavar and capecitabine improved progression-free survival (PFS) by 74% in a trial of 229 women with locally advanced or metastatic breast cancer. PFS was 7.4 months in the combination arm versus 4.1 months in the placebo group (HR, 0.65; P = .0339). “Interestingly enough, the statistical significance of these efficacy results were comparable across the first line and the second line,” said Coles, “with dramatic improvements in PFS in both of these populations.” The most commonly observed toxicity was hand-foot skin reaction, which is a complication of both agents and was not unexpected. Investigators described this adverse effect as manageable. “Despite this particular tolerability issue, the overwhelming benefit of the combination of Nexavar and capecitabine, we believe, is really very exciting,” Coles said.

A second study, led by William Gradishar, MD, of Northwestern University, Evanston, Illinois, demonstrated a favorable trend toward improved PFS for Nexavar plus paclitaxel versus paclitaxel alone in women with HER 2-negative breast cancer. While the data did not meet statistical significance for PFS, Coles said it nevertheless demonstrated that Nexavar is active in breast cancer.

Another study presented at SABCS that Onyx was not involved in but which generated a lot of interest showed that Nexavar resensitized some breast cancer patients to aromatase inhibitors. The data were preliminary, but Coles said Onyx was “working with the investigator of that trial to better understand these findings and make a judgment as to whether we would want to initiate a company-sponsored trial in this area.”

Onyx is proceeding with a phase III trial and several phase II trials of Nexavar in the HER2- negative patient population. One phase II study is expected to release top-line results in late 2010 on the potential role of Nexavar in combination with gemcitabine (Gemzar) or capecitabine in metastatic breast cancer patients who have progressed on bevacizumab (Avastin). Another trial is accruing patients with metastatic breast cancer who will receive Nexavar combined with docetaxel or letrozole (Femara).

Nexavar has also shown activity in lung and thyroid cancer, and Coles said Onyx has also moved forward with phase II trials for these indications. Results from a pivotal non–small cell lung cancer phase III trial investigating Nexavar are due later this year. Coles said the company is anticipating strongly positive results and looks forward to sharing them with investors.

If China proceeds with a plan under discussion to reimburse Chinese citizens for cancer drugs, it would be good news for Onyx. Nearly half the world’s liver cancer cases are in China, and currently cancer drugs are paid for out of pocket. Onyx and other pharmaceutical companies are in talks with the Chinese government on how it might implement the drug reimbursement program.

New Drug Application planned for carfilzomib


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