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Pharmaceutical and Biotech News

Pharmaceutical and Biotech News concentrates on events that mark progress (or failure) in the development of promising new treatments in challenging therapeutic areas.  These include key Phase 2 and Phase 3 clinical studies as well as evaluations and marketing authorizations by major regulatory agencies (such as the FDA and EMA). The areas covered are as follows:

Oncology

Metabolic and inflammatory diseases and syndromes

Coagulation/anticoagulation

Bacterial, viral and fungal infections

Neurological disorders (mostly stroke, multiple sclerosis and Alzheimer's disease)

In most cases, company announcements are dissected for pertinent facts and PR statements are either removed or placed in context. The title is linked to the company's public release.  Personal interviews and reviews by a variety of sites may be included.  Occasional commentary -clearly marked as such in red- is included as a counterpoint to the PR and to highlight specific compounds or clinical studies worthy of greater emphasis.  Marketed drugs, mentioned in these pages, will be linked, whenever possible, to their current US Package Inserts.

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19 January 2012

Data from the Phase 3 study of regorafenib (BAY 73-4506) in metastatic colorectal cancer 

Onyx Pharmaceuticals, Inc. and Bayer HealthCare announced results from the  Phase 3 CORRECT clinical study from the investigational compound regorafenib (BAY 73-4506) in metastatic colon cancer.

Regorafenib (BAY 73-4506) is a multikinase inhibitor that binds to and inhibits VEGFR-2 and -3, and tumor cell signaling kinases including RET, KIT, PDGFR, and Raf.  This activity inhibits tumor angiogenesis and tumor cell proliferation.

The CORRECT trial is an international, multicenter, randomized, double-blind, placebo-controlled study that enrolled 760 patients with mCRC whose disease has progressed after approved standard therapies. Patients were randomized to receive either regorafenib plus best supportive care (BSC) or placebo plus BSC. Treatment cycles consisted of 160 mg of regorafenib (or matching placebo) once daily for three weeks on / one week off plus BSC. The primary endpoint of this trial was overall survival. Secondary endpoints included progression-free survival, objective tumor response rate and disease control rate. The safety and tolerability of the two treatment groups were also compared.

The CORRECT study was unblinded in late 2011 by the recommendation of an independent Data Monitoring Committee following a pre-planned interim analysis that determined that the regorafenib arm showed significant improvement in overall survival.  The patients on the placebo arm were offered treatment with regorafenib.

The study met its primary endpoint, showing statistically significant improvement in overall survival (OS) by 29% (HR=0.77, p=0.0052, median OS: 6.4 months vs. 5.0 months for the placebo group). Additionally, findings from the secondary endpoints of the CORRECT study showed statistically significant improvement in progression-free survival (PFS) (HR=0.49, p<0.000001, median PFS: 1.9 months vs. 1.7 months) and an improvement in disease control rate (44.8% vs. 15.3%) in patients treated with regorafenib compared to those treated with placebo. The difference in objective response rate between the two arms (1.0% vs. 0.4%) did not reach statistical significance. The most common drug-related treatment-emergent adverse events included fatigue (47.4% vs. 28.1%), hand-foot skin reaction (46.6% vs. 7.5%), diarrhea (33.8% vs. 8.3%), anorexia (30.4% vs. 15.4%), hypertension (27.8% vs. 5.9%), oral mucositis (27.2% vs. 3.6%) and rash/desquamation (26.0% vs. 4.0%) for patients receiving regorafenib as compared to placebo.

According to the public releases, Bayer plans to submit regorafenib for marketing authorization in mCRC in 2012. In the US, the potential market is approximately 15,000 metastatic colorectal cancer patients who fail treatment with Avastin, Erbitux or Vectibix.

Clinical Development Advances in 2011

Clinical Development Advances in 2010