October 26, 2011 — A phase 3 study of metastatic colorectal cancer (mCRC) has been stopped after a significant improvement in overall survival was seen with the investigational drug regorafenib (under development by Bayer).
The finding comes from a preplanned interim analysis, the company announced. The study has now been unblinded, and all patients who were in the placebo group have been offered the drug.
The trial, known as CORRECT, enrolled 760 patients with mCRC whose disease progressed after approved standard therapies. It was being conducted at multiple centers in Australia, China, Europe, Japan, and North America.
All patients received best supportive care and were randomized to receive either regorafenib or placebo. Treatment cycles consisted of 160 mg of regorafenib (or matching placebo) given once daily for 3 weeks, followed by a week without therapy.
"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," Kemal Malik, MD, head of global development at Bayer, said in a statement.
"There are very few treatment options available for patients with colorectal cancer whose disease has progressed following treatment with existing therapies," he noted.
Regorafenib is an oral multikinase inhibitor that is being investigated in various tumor types. The drug has been granted Fast Track designation by the US Food and Drug Administration (FDA) for the treatment of patients with mCRC who have progressed after approved standard therapies.
In addition, regorafenib had been granted Orphan Drug status by the FDA for use in gastrointestinal stromal tumors (GIST), and was granted Fast Track designation for the treatment of patients with metastatic and/or unresectable GIST whose disease has progressed despite at least imatanib and sunitinib treatments.
Reacting to the announcement, John Marshall, MD, professor of medicine and chief of hematology/oncology at the Lombardi Comprehensive Cancer Center, Georgetown University, Washington, DC, told Medscape Medical News that "we have not had a new drug in colon cancer since 2005, despite many efforts. Importantly, this agent represents a new class of drug for this disease, and we hope that further studies will prove that it has even greater value in earlier lines of therapy.
The finding comes from a preplanned interim analysis, the company announced. The study has now been unblinded, and all patients who were in the placebo group have been offered the drug.
The trial, known as CORRECT, enrolled 760 patients with mCRC whose disease progressed after approved standard therapies. It was being conducted at multiple centers in Australia, China, Europe, Japan, and North America.
All patients received best supportive care and were randomized to receive either regorafenib or placebo. Treatment cycles consisted of 160 mg of regorafenib (or matching placebo) given once daily for 3 weeks, followed by a week without therapy.
"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," Kemal Malik, MD, head of global development at Bayer, said in a statement.
"There are very few treatment options available for patients with colorectal cancer whose disease has progressed following treatment with existing therapies," he noted.
Regorafenib is an oral multikinase inhibitor that is being investigated in various tumor types. The drug has been granted Fast Track designation by the US Food and Drug Administration (FDA) for the treatment of patients with mCRC who have progressed after approved standard therapies.
In addition, regorafenib had been granted Orphan Drug status by the FDA for use in gastrointestinal stromal tumors (GIST), and was granted Fast Track designation for the treatment of patients with metastatic and/or unresectable GIST whose disease has progressed despite at least imatanib and sunitinib treatments.
Reacting to the announcement, John Marshall, MD, professor of medicine and chief of hematology/oncology at the Lombardi Comprehensive Cancer Center, Georgetown University, Washington, DC, told Medscape Medical News that "we have not had a new drug in colon cancer since 2005, despite many efforts. Importantly, this agent represents a new class of drug for this disease, and we hope that further studies will prove that it has even greater value in earlier lines of therapy.
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