An experimental drug for advanced colorectal cancer that available treatments have failed to halt, has shown promise in a clinical trial, says Bayer HealthCare, the company that makes it. The results of the phase III trial show that compared to placebo, regorafenib slowed tumor growth and extended survival.
In a statement released yesterday, Bayer announced that the Phase III CORRECT (Colorectal cancer treated with regorafenib or placebo after failure of standard therapy) trial “met its primary endpoint, showing statistically significant improvement in overall survival … in patients with metastatic colorectal cancer (mCRC) whose disease had progressed after approved standard therapies”.
The statement goes on to add that the trial also shows that regorafenib showed statistically significant improvement in progression-free survival and improvement in disease control rate in the patients who received the drug compared to those who received placebo.
The trial results show that more of the side effects commonly or occasionally seen with chemotherapy occurred with the drug than with placebo, including fatigue, hand-foot skin reaction, diarrhea, anorexia, high blood pressure, oral mucositis (inflammation of the lining of the mouth) and rash/skin peeling.
The trial was “unblinded” late in 2011 after an independent data monitoring committee said the drug was showing significant improvement in overall survival and patients receiving placebo should be offered the option to take it.
It was conducted in North America, Europe, China, Japan and Australia and enrolled 760 patients.
Bayer said they will be seeking Food and Drug Administration (FDA) approval for regorafenib within the next 12 months. If approved, it will be the first new treatment for colorectal cancer in over five years.
Dr Axel Grothey, MD, Professor of Oncology at the Mayo Clinic is a co-principal investigator on the trial.
He is presenting the trial results at the 2012 Gastrointestinal Cancers Symposium of the American Society of Clinical Oncology (ASCO-GI), in San Francisco later this week.
The oral abstract presentation (LBA number 385) is set to take place at 14:30 h PT on 21 January in the Level 3 Ballroom, Moscone Center West.
Colorectal cancer is the third most commonly diagnosed cancer and the third leading cause of cancer death in the US, in both men and women.
About half of patients diagnosed with the disease have the advanced form (metastases, usually to the liver), either at the time of diagnosis or due to recurrent disease.
Written by Catharine Paddock PhD