placebo plus BSC. Median OS was 6.4 months with Stivarga versus 5.0 months with placebo; median PFS was 2.0 months with Stivarga versus 1.7 months with placebo. No difference in overall response rate was observed. Five patients (1%) in the regorafenib arm and one patient (0.4%) in the placebo arm experienced partial responses.1
The most frequently observed adverse drug reactions (≥30%) in patients receiving Stivarga were asthenia/fatigue, decreased appetite and food intake, hand-foot-skin reaction (HFSR)/palmar-plantar erythrodysesthesia (PPE), diarrhea, mucositis, weight loss, infection, hypertension and dysphonia. The most serious adverse drug reactions in patients receiving Stivarga included hepatotoxicity, hemorrhage, and gastrointestinal perforation. Full results from the study were presented at the 2012 Gastrointestinal Cancers Symposium of the American Society of Clinical Oncology (ASCO) (January 2012), and updated results at the 48th ASCO Annual Meeting (June 2012).2,3
“The approval of Stivarga reflects Bayer’s commitment to confronting the challenges of difficult-to-treat cancers,” said Pamela A. Cyrus, MD, Vice President and Head of U.S. Medical Affairs, Bayer HealthCare Pharmaceuticals. “Patients with metastatic colorectal cancer whose disease has returned after treatment will now have a new option that has been shown to prolong survival and keep the cancer from progressing.”
About Colorectal Cancer
Colorectal cancer is the third most commonly diagnosed cancer and the third leading cause of cancer death in the United States, in both men and women. It is estimated that more than 143,000 people will be diagnosed with CRC in 2012, and nearly 52,000 people will die from the disease.4 Approximately 50% of colon cancer patients will be diagnosed with metastases (most commonly to the liver) either at the time of diagnosis or due to recurrent disease.5
In mCRC, KRAS status is an important biomarker and can be a predictor of treatment response.6 Approximately 40% of colorectal cancers are characterized by mutations in the KRAS gene.7
About the CORRECT Study
CORRECT was an international, multicenter, randomized, double-blind, placebo-controlled Phase III study that enrolled 760 patients with mCRC whose disease had progressed during or within three months following last administration of approved standard therapies. Patients were randomized to receive regorafenib plus 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.1
About Stivarga (regorafenib)
Stivarga is indicated for the treatment of patients with mCRC who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if KRAS wild type, an anti-EGFR therapy.1
Stivarga is an oral multi-kinase inhibitor that inhibits various kinases within the mechanisms involved in tumor growth and progression – angiogenesis, oncogenesis and the tumor microenvironment. In preclinical studies, Stivarga inhibits several angiogenic VEGF receptor tyrosine kinases that play a role in tumor neoangiogenesis (the growth of new blood vessels). It also inhibits various oncogenic and tumor microenvironment kinases including KIT, RET, PDGFR, and FGFR, which individually and collectively impact upon tumor growth, formation of a stromal microenvironment and diseas |
