The investigational drug regorafenib extended overall survival in patients with treatment-refractory advanced colorectal cancer by 1.4 months in a phase III trial, according to its manufacturer.
Data to be presented this weekend at the American Society of Clinical Oncology's Gastrointestinal Cancers Symposium include a median overall survival time of 6.4 months with regorafenib in the 760-patient CORRECT trial, compared with 5.0 months for the placebo group (P=0.005), Bayer HealthCare said in a press release.
The trial's blinding was lifted prematurely last October when an interim analysis showed a clear benefit for the drug. Bayer said at the time that the study had met its primary endpoint of improved overall survival but gave no specific data.
Other results from the study, released Wednesday by Bayer, included the following:
Median progression-free survival was 1.9 months with regorafenib versus 1.7 months for placebo (P<0.000001)
Disease control rate was 44.8% with regorafenib versus 15.3% with placebo (P<0.000001)
Objective response rate was 1.0% with regorafenib versus 0.4% with placebo (P=0.188)
Patients receiving regorafenib survived for 6.4 months on average compared with five months for those who were given the placebo. Moreover, 44 percent of patients on regorafenib had prolonged periods in which the cancer was not growing.
There was a lot of variability: Some patients had dramatic responses, such as one year of survival, while others did not benefit, said lead investigator Dr. Axel Grothey, a professor of oncology at the Mayo Clinic in Rochester, Minn. Grothey is presenting the data this week at the Gastrointestinal Cancers Symposium of the American Society of Clinical Oncology meeting in San Francisco.
Regorafenib is a type of medication called an angiogenesis inhibitor. It shuts down the process by which tumors induce the growth of new blood vessels in order to survive. The drug appears to block a number of different molecular pathways that affect angiogenesis.
"For colon cancer patients, this is an important step," Lenz said. "This shows if you continue to inhibit angiogenesis in different ways, patients have a significant overall survival benefit.
Data to be presented this weekend at the American Society of Clinical Oncology's Gastrointestinal Cancers Symposium include a median overall survival time of 6.4 months with regorafenib in the 760-patient CORRECT trial, compared with 5.0 months for the placebo group (P=0.005), Bayer HealthCare said in a press release.
The trial's blinding was lifted prematurely last October when an interim analysis showed a clear benefit for the drug. Bayer said at the time that the study had met its primary endpoint of improved overall survival but gave no specific data.
Other results from the study, released Wednesday by Bayer, included the following:
Median progression-free survival was 1.9 months with regorafenib versus 1.7 months for placebo (P<0.000001)
Disease control rate was 44.8% with regorafenib versus 15.3% with placebo (P<0.000001)
Objective response rate was 1.0% with regorafenib versus 0.4% with placebo (P=0.188)
Patients receiving regorafenib survived for 6.4 months on average compared with five months for those who were given the placebo. Moreover, 44 percent of patients on regorafenib had prolonged periods in which the cancer was not growing.
There was a lot of variability: Some patients had dramatic responses, such as one year of survival, while others did not benefit, said lead investigator Dr. Axel Grothey, a professor of oncology at the Mayo Clinic in Rochester, Minn. Grothey is presenting the data this week at the Gastrointestinal Cancers Symposium of the American Society of Clinical Oncology meeting in San Francisco.
Regorafenib is a type of medication called an angiogenesis inhibitor. It shuts down the process by which tumors induce the growth of new blood vessels in order to survive. The drug appears to block a number of different molecular pathways that affect angiogenesis.
"For colon cancer patients, this is an important step," Lenz said. "This shows if you continue to inhibit angiogenesis in different ways, patients have a significant overall survival benefit.
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