The HealthCare unit of Bayer (BAYRY) recently announced that its cancer candidate regorafenib fared well in a phase III study (GRID: n=199), which evaluated patients suffering from metastatic and/or unresectable gastrointestinal stromal tumors (:GIST). The disease had progressed in the evaluated patients in spite of being previously treated with Novartis’ (NVS) Gleevec and Pfizer’s (PFE) Sutent.
Results from the randomized, double-blind, placebo-controlled, multi-center, cross-over study revealed that treatment with regorafenib (160 mg) plus the best supportive care (BSC) reduced the risk of the disease progressing further or even death by 73% compared to those in the placebo + BSCarm. Bayer intends to seek marketing approval for regorafenib for the GIST indication in the second half of 2012.
Apart from GIST, Bayer is evaluating regorafenib in patients suffering from metastatic colorectal cancer (mCRC). Bayer presented encouraging data from a phase III study (CORRECT: n=760), which evaluated regorafenib in mCRC patients whose disease had progressed even after treatment with the standard drugs for the disease. The data was presented at the 48th annual conference of the American Society of Clinical Oncology (TATD).
Results from the study revealed that there was a significant improvement in progression-free survival and overall survival in patients treated with regorafenib (160 mg) plus the BSC compared to those in the placebo + BSCarm. Bayer is seeking approval of the candidate for the mCRC indication in the US and the EU. Once regorafenib is commercialized, Bayer will have to make royalty payments on global sales of the candidate to Onyx Pharmaceuticals, Inc. (ONXX), per an agreement inked last year.
We have a Neutral recommendation on Bayer. The stock carries a Zacks #3 Rank (Hold rating) in the short run.
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