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Positive Data on Bayer/Onyx's Nexavar

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The HealthCare segment of Bayer (BAYRY) and partner, Onyx Pharmaceuticals Inc. (ONXX) recently announced positive results from the phase III DECISION study on Nexavar (sorafenib) tablets in patients suffering from locally advanced or metastatic radioactive iodine (RAI)-refractory differentiated thyroid cancer.

Bayer mentioned in its press release that currently there are no specific approved treatments for radioactive iodine refractory differentiated thyroid cancer.

Results from the study revealed a significant increase in progression-free survival (PFS) for patients treated with Nexavar compared to placebo. Data revealed a 41% reduction in the risk of disease progression or death for patients receiving Nexavar compared to patients under placebo. Bayer intends to present data from this study at the 49th Annual Meeting of the American Society of Clinical Oncology (TATD) in Chicago.

Hand-foot skin reaction, diarrhea, alopecia, rash/desquamation, fatigue, weight loss and hypertension were some of the most common treatment-emergent adverse events in the Nexavar arm.

Bayer now plans to submit marketing authorization application for Nexavar for the treatment of RAI-refractory differentiated thyroid cancer based on the positive findings from the phase III DECISION study.

We note that Nexavar is already approved as an oral anti-cancer therapy for liver cancer and for the treatment of patients suffering from advanced kidney cancer in over 100 countries around the globe. The drug is also approved for the treatment of hepatocellular carcinoma and advanced renal cell carcinoma who have failed prior interferon-alpha/interleukin-2 based therapy or are considered unsuitable for such therapy in the EU.

Bayer presently carries a Zacks Rank #3 (Hold). Meanwhile, other stocks such as Jazz Pharmaceuticals (JAZZ) and Santarus Inc. (SNTS) currently look more attractive carrying a Zacks Rank #1 (Strong Buy).

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