Data from an ongoing clinical evaluation of a combination of two drugs in patients with advanced melanoma is showing promise as a new way of treating the disease.
Tampa, Fla. - Data from an ongoing clinical evaluation of a combination of two drugs in patients with advanced melanoma is showing promise as a new way of treating the disease.
Researchers with H. Lee Moffitt Cancer Center conducted the study in 125 patients. More than half of the patients were given dabrafenib - a drug that targets the gene known as BRAF - in addition to the MEK-inhibitor trametinib. The patients demonstrated objective responses to the therapies, MedPage Today reports. An additional 38 percent showed stable disease after the dual therapies.
More than 90 percent of the patients had stable disease, partial response or complete response, according to study investigators.
A subgroup of 24 patients given the dose assigned for phase 3 evaluation - 150 mg of dabrafenib and 2 mg of trametinib - had either stable disease or objective responses.
The combination of drugs demonstrated superior activity against BRAF-mutant cell lines than either drug alone, MedPage Today reports. The therapies also caused fewer side effects than a BRAF inhibitor alone, such as skin lesions and BRAF-inhibitor resistance.
Four doses were evaluated, and the disease control rate ranged from 92 to 100 percent. Patients treated at the dose chosen for phase 3 evaluation had a median progression-free survival of nearly 11 months, compared to between 5.5 and 7 months in the other three groups.
The most common side effect to the drugs was fever, chills, fatigue and nausea. Roughly a quarter of the patients required dose reductions due to fever.
The data was presented as an abstract prior to the American Society of Clinical Oncology conference, and has not yet been peer-reviewed and published in a scholarly journal.
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