A newly approved drug for patients with metastatic melanoma nearly doubles median survival times, according to researchers from 13 sites in the United States and Australia.
The finding could profoundly change treatment of melanoma, according to a news release from UCLA's Jonsson Comprehensive Cancer Center, one of the participating institutions.
The data comes from an international Phase II study of vemurafenib (Zelboraf) that included 132 patients followed for at least one year.
Patients with this advanced form of melanoma that has spread to other organs typically survive about nine months. Patients taking vemurafenib, which blocks a mutated BRAF protein, survived an average of 15.9 months, said study senior author Antoni Ribas, MD, a professor of hematology/oncology and a researcher at the Jonsson Cancer Center.
"This study shows that Zelboraf changes the natural history of this disease," Ribas said in a news release. "This data is beyond what I would have expected. We're seeing a significant number of patients with durable responses to the drug, and that the whole group of treated patients is living longer. These results tell us that this drug is having a very big impact, and this changes the way we treat metastatic melanoma."
About 50% of patients with metastatic melanoma, or 4,000 people a year, have the BRAF mutation and can be treated with vemurafenib in the form of Zelboraf, a pill taken twice a day, Ribas said. Of those, 53% in the study had an objective response to the drug, meaning their tumors shrunk by more than 30%. An additional 30% of patients had tumor responses of lesser magnitude. Only 14% of patients with the BRAF mutation failed to respond to the medication.
The drug represents a breakthrough in treating metastatic melanoma. Before, 10% or less of patients with this advanced form of the disease responded to any of the available conventional treatments, Ribas said.
"We knew this drug would make the melanomas shrink in a large proportion of patients and that it worked better than chemotherapy," Ribas said. "We did not know that patients taking Zelboraf were living longer until now."
The main limitation with vemurafenib is that tumors eventually become resistant. But Jonsson Cancer Center researchers are studying this resistance and have uncovered several mechanisms by which the cancer gets around the medication. They are seeking agents to target those mechanisms, Ribas said.
Zelboraf was approved by the Food and Drug Administration for use in metastatic melanoma in August 2011. About 70,000 new cases of melanoma are diagnosed each year in the United States. Of those, 8,000 people will die of the disease.
The finding could profoundly change treatment of melanoma, according to a news release from UCLA's Jonsson Comprehensive Cancer Center, one of the participating institutions.
The data comes from an international Phase II study of vemurafenib (Zelboraf) that included 132 patients followed for at least one year.
Patients with this advanced form of melanoma that has spread to other organs typically survive about nine months. Patients taking vemurafenib, which blocks a mutated BRAF protein, survived an average of 15.9 months, said study senior author Antoni Ribas, MD, a professor of hematology/oncology and a researcher at the Jonsson Cancer Center.
"This study shows that Zelboraf changes the natural history of this disease," Ribas said in a news release. "This data is beyond what I would have expected. We're seeing a significant number of patients with durable responses to the drug, and that the whole group of treated patients is living longer. These results tell us that this drug is having a very big impact, and this changes the way we treat metastatic melanoma."
About 50% of patients with metastatic melanoma, or 4,000 people a year, have the BRAF mutation and can be treated with vemurafenib in the form of Zelboraf, a pill taken twice a day, Ribas said. Of those, 53% in the study had an objective response to the drug, meaning their tumors shrunk by more than 30%. An additional 30% of patients had tumor responses of lesser magnitude. Only 14% of patients with the BRAF mutation failed to respond to the medication.
The drug represents a breakthrough in treating metastatic melanoma. Before, 10% or less of patients with this advanced form of the disease responded to any of the available conventional treatments, Ribas said.
"We knew this drug would make the melanomas shrink in a large proportion of patients and that it worked better than chemotherapy," Ribas said. "We did not know that patients taking Zelboraf were living longer until now."
The main limitation with vemurafenib is that tumors eventually become resistant. But Jonsson Cancer Center researchers are studying this resistance and have uncovered several mechanisms by which the cancer gets around the medication. They are seeking agents to target those mechanisms, Ribas said.
Zelboraf was approved by the Food and Drug Administration for use in metastatic melanoma in August 2011. About 70,000 new cases of melanoma are diagnosed each year in the United States. Of those, 8,000 people will die of the disease.
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