NEW YORK, UNITED STATES - In an early-stage trial involving patients with melanoma that had spread to other sites in the body, a biological drug dubbed ipilimumab was generally well tolerated and showed signs of attacking the malignancy, researchers report.

"Ipilimumab can induce both clinically relevant responses and long-term stable disease," lead investigator Dr. Jeffrey Weber told Reuters Health.

As reported in the Journal of Clinical Oncology, Weber, at the H. Lee Moffitt Cancer Center in Tampa, Florida, and colleagues studied 88 patients with unresectable metastatic melanoma.

They were given either a single high dose of ipilimumab, or multiple low doses, or multiple medium doses.

Although a maximum-tolerated dose was not reached in the first two groups, 6 of the 23 patients given multiple medium doses showed toxic side effects that limited the amount that could be given.

However, one patient in this group had a complete response, one had a partial response and seven had stable disease, giving a disease control rate of 39 percent.

Durable responses were seen in all of the groups, say the investigators, and they conclude that the multiple medium-dose regimen provided the best results.

"Ipilimumab is an active drug in metastatic melanoma," Weber concluded.

Overall survival in more recent studies, aggregating over 300 patients, "suggests that median survival for mostly untreated first-line patients is in excess of 13 months, which is quite favorable," he added.

SOURCE: Journal of Clinical Oncology, November 17, 2008.