According to an announcement made by Bayer HealthCare Pharmaceuticals, the Phase III trial of its investigational compound regorafenib (BAY 73-4506) to treat individuals with metastatic colorectal cancer (mCRC) whose disease progressed after approved standard treatments has reached its initial endpoint of statistically significant improvement in overall survival. The result was obtained from a pre-planned interim examination carried out by an independent Data Monitoring Committee (DMC) of the CORRECT (Patients with metastatic colorectal cancer treated with regorafenib or placebo after failure of standard therapy) trial. Following the suggestion of the DMA, the investigation has been unblinded and participants in the placebo group will be offered treatment with regorafenib. The study revealed that the safety and tolerability of the drug were mostly as anticipated.
Kemal Malik, MD, Head of Global Development and member of the Bayer HealthCare Executive Committee, explained:
“These data are significant because they demonstrate that regorafenib increased overall survival in patients with heavily pretreated metastatic colorectal cancer, an area of high unmet medical need.”
Discussions will continue between Bayer and health authorities across the globe, including the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA), in regards to the next move in filing for approval of the drug to treat mCRC.
Bayer and Onyx Pharmaceuticals recently reached an agreement in which Onyx will receive a royalty on any worldwide net sales in the future of the drug in oncology.
760 individuals with metastatic colorectal cancer whose disease had progressed following approved standard treatments were enrolled in the CORRECT trial, an international, multicenter, randomized, double-blind, placebo-controlled study, carried out in North America, Europe, Australia, China and Japan.
Participants were randomly assigned to two groups. One group received regorafenib as well as best supportive care (BSC) while patients in the other group received placebo in addition to BSC. Participants in the regorafenib group received 160mg of the drug once daily for three weeks on / one week off plus BSC. Those in the placebo group received 160mg of placebo for the same treatment cycle plus BSC. The initial endpoint of the investigation was overall survival. Secondary endpoints included disease control rate, objective tumor response rate as well as progression free survival. Researchers also compared the safety and tolerability between the groups.
Colorectal cancer (also known as bowel cancer), is a cancer caused when malignant (cancer) cells develop in the tissues of the colon or rectum. Several cancers in the colon and rectum are adenocarcinomas, which are responsible for over 90% of all large bowel tumors.
In the U.S., colorectal cancer is the third most prevalent diagnosed cancer and makes up for a third of all cancer deaths in both men and women. In 2011, it has been estimated that over 140,000 individuals will be diagnosed with the disease, killing approximately 50,000 individuals. Around 50% of patients with the disease will be diagnosed with metastases (more commonly to the liver) either when diagnosed or because of recurrent disease.
Regorafenib is an investigational oral multi-kinase inhibitor of angiogenic, stromal and oncogenic receptor tyrosine kinases (TK). At present it is being researched in clinical trails for potential treatment for individuals with various types of tumors.
Regorafenib is not approved by the EMA, FDA or any other health authorities.
The FDA granted regorafenib an orphan drug designation to treat individuals with gastrointestinal stromal tumors (GIST). The goal of orphan drug designation is to encourage the development of medications involved in the diagnosis, prevention or treatment of a medical condition that affects less than 200,000 individuals in the country.
Regorafenib was granted Fast Track designation by the FDA for the treatment of patients with metastatic and/or unresectable GIST whose disease has progressed despite at least imatinib and sunitinib as prior treatments, as well as for the treatment of patients with mCRC who have progressed after approved standard therapies. Fast Track is a process designed to facilitate the development, and expedite the review of drugs to treat serious diseases and fill an unmet medical need.
The FDA also granted regorafenib Fast Track designation for the treatment of people with metastatic and/or unresectable GIST whose disease has progressed even though they had undergone at least imatinib and sunitinib as previous treatments, and for the treatment of those with mCRC who have progressed after approved standard therapies. Fast Track is a process designed to assist in the development, and speed up the review of drugs to treat serious diseases and fill an unmet medical need.
Written by Grace Rattue