German conglomerate Bayer AG (BAYRY.PK, BAYZF.PK) said Monday that a late-stage study evaluating its potential blockbuster cancer compound regorafenib in patients with one of the most common tumors of the gastrointestinal tract met its main goal of the patients staying free of the disease progressing further.
The study enrolled 199 patients with metastatic and/or unresectable gastrointestinal stromal tumors, or GIST - an aggressive form of stomach tumor.
These patients' disease had progressed despite prior treatment with imatinib and sunitinib - the standard treatments for GIST. The Phase 3 study met its primary endpoint of progression-free survival.
The investigational compound is being developed by Bayer. California-based Onyx Pharmaceuticals, Inc. (ONXX) has a royalty agreement with Bayer on any future global net sales of the drug. In the U.S., both companies will jointly promote regorafenib.
Bayer plans to submit a New Drug Application to the U.S. Food and Drug Administration for the drug in GIST in the second half of 2012. Bayer has already submitted an NDA for regorafenib for a different use - i.e. in the treatment of patients with metastatic colorectal cancer.
Bayer and Onyx also cooperate on a compound similar to regorafenib called Nexavar, which last month failed to meet its primary goal in a late-stage study evaluating its potential in patients with advanced relapsed or refractory non-squamous non-small cell lung cancer.
In a separate development, Bayer HealthCare said an updated data from a pivotal Phase III trial for another investigational drug Alpharadin (radium-223 dichloride) confirm the overall survival benefit in men with prostate cancer spread to the bone.
The updated data from the study, dubbed ALSYMPCA, showed that radium-223 dichloride improved overall survival by 44 percent in men with castration-resistant prostate cancer, or CRPC.
Radium-223 dichloride was granted Fast Track designation by the FDA. The Fast Track process is designed to facilitate the development, and expedite the review, of drugs to treat serious diseases and fill an unmet medical need.
Alpharadin was developed by Norway-based Algeta ASA (ALGZF.PK), which initiated ALSYMPCA trial in 2008. In September 2009, Bayer agreed to develop, apply for global health authority approvals, and commercialize radium-223 dichloride globally.
Chris Parker, principal investigator of ALSYMPCA, said, "Radium-223 dichloride is the first therapy specifically addressing prostate cancer that has spread to the bone that has shown in a Phase III trial to significantly improve overall survival."
The announced data were presented at the 48th Annual Meeting of the American Society of Clinical Oncology in Chicago.
On Frankfurt's Xetra, Bayer shares are currently trading at 48.03 euros, down 0.78 euros or 1.61 percent.
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