The HealthCare unit of Bayer (BAYRY) recently announced that a phase III trial (DECISION: n=417) of Nexavar (sorafenib), co-developed and marketed with Onyx Pharmaceuticals Inc. (ONXX), has met the primary endpoint.
The international, multicenter, randomized, placebo-controlled study evaluated the safety and efficacy of Nexavar versus placebo in patients suffering from locally advanced or metastatic radioactive iodine (RAI)-refractory differentiated thyroid cancer.
Data from the phase III study revealed that treatment with Nexavar resulted in statistically significant improvement in progression-free survival compared to those treated with placebo. Moreover, the safety and tolerability of the drug were found identical to the historical findings. The companies intend to unfurl detailed data from the study shortly.
Bayer intends to seek approval of Nexavar for the indication on the basis of encouraging results from the DECISION study. Currently, Nexavar is approved for the treatment of unresectable liver cancer and advanced kidney cancer. Approval for the thyroid cancer indication would further boost Nexavar’s sales potential.
Bayer stated in its press release that the incidence of thyroid cancer is on the rise. This form of the disease is the sixth most common cancer in women. Bayer also stated that the patient population affected by thyroid cancer includes three times as many women as men. Bayer further stated that more than 160,000 new cases of thyroid cancer come up every year worldwide. Approximately 25,000 people succumb to the disease across the globe annually.
We have a Neutral recommendation on Bayer. The stock carries a Zacks #3 Rank (Hold). Meanwhile, Onyx Pharma carries a Zacks #1 Rank (Strong Buy).