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NEW YORK (Reuters Health) - Cytotoxic T lymphocyte-associated antigen 4 (CTLA4) blockade with tremelimumab, a fully human anti-CTLA4 monoclonal antibody, is generally well tolerated and prompts antitumor activity in some patients with advanced melanoma.
This finding is from a Phase I/II trial in patients with metastatic melanoma, the first phase involving 28 patients treated with 3, 6 or 10 mg/kg monthly intravenous infusions of tremelimumab for a year, and the second phase in 89 patients given 10 mg/kg every month or 15 mg/kg every 3 months.
In a January 12th on-line publication in the Journal of Clinical Oncology, Dr. Luis H. Camacho of Oncology Consultants, Houston, Texas, and colleagues report that of 84 evaluable patients, 8 (10%) attained objective antitumor responses. There was 1 complete response in both the 10 and 15 mg/kg groups and 3 partial responses in each group.
Grade 3 and 4 adverse events were seen in 27% of the 10 mg/kg patients and 13% in the 15 mg/kg group. Serious adverse events were also less frequent in the 15 mg/kg group (9% versus 23%).
The researchers are now conducting further studies using the 15 mg/kg per 3-month regimen.
Commenting on the findings, Dr. Camacho told Reuters Health that "CTLA4 blockade with monoclonal antibodies has demonstrated antitumor activity in patients with advanced melanoma and other tumor types. This approach remains a promising targeted anticancer therapy."
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