Bayer HealthCare's Regorafenib (BAY 73-4506) drug has demonstrated the efficacy in Phase 3 colorectal cancer treated with Regorafenib or placebo after failure of standard therapy (CORRECT) trial.
Regorafenib is an investigational oral multi-kinase inhibitor targeting angiogenic, stromal and oncogenic kinases and is now being examined for its ability in treating patients with various tumour types.
The CORRECT trial is an international multicentre randomised double-blind placebo-controlled Phase 3 study including 760 patients with metastatic colorectal cancer (mCRC) whose disease had progressed during or within 3 months following last administration of approved standard therapies.
Patients were randomised to receive either Regorafenib plus best supportive care (BSC) or placebo plus BSC, with treatment cycles including 160mg of Regorafenib once daily for three weeks on, one week off plus BSC. In the study, the primary endpoints included overall survival (OS), and the secondary endpoints were progression-free survival (PFS) and disease control rate.
The study conducted in North America, Europe, China, Japan and Australia, reported that Regorafenib showed a 29% improvement in OS, improved PFS to 1.9 months versus 1.7 months for placebo and improved disease control rate by 44.8%.
As per the recommendation from an independent data monitoring committee, the CORRECT study was unblinded in late 2011 following a preplanned interim analysis that demonstrated that Regorafenib arm showed improvement in overall survival. In 2012, Bayer intends to submit Regorafenib for marketing authorisation in mCRC. Bayer and Onyx entered into an agreement last year, under which Onyx will receive a royalty on any future global net sales of Regorafenib in oncology.
Colorectal cancer is a disease in which malignant (cancer) cells form in the tissues of the colon or rectum, which account for more than 90% of all large bowel tumours. The common drug-related treatment-emergent adverse events seen were fatigue, hand-foot skin reaction, diarrhea, anorexia, hypertension, oral mucositis and rash/desquamation.