Lilly released results today from a Phase II study evaluating Lilly Oncology's tasisulam, a novel anti-cancer agent, in patients with metastatic melanoma, the deadliest form of skin cancer. Study results will be presented during the 46th Annual Meeting of the American Society of Clinical Oncology (ASCO) held in Chicago, Ill. on June 6, 2010.
"While great strides have been made in treating some cancers over the past decade, others – such as melanoma – continue to be challenging to treat," said John M. Kirkwood, M.D., co-leader of the Melanoma Program of the University of Pittsburgh Cancer Institute. "Ongoing research is critical if we are to find appropriate treatments for patients who need them most."
The Phase II study (Abstract #8541) evaluated the use of tasisulam as a second-line treatment in patients with unresectable or metastatic melanoma. The trial's primary objective was to determine overall response rate and its two secondary objectives were to determine progression-free survival and overall survival. Of the 68 patients enrolled in the study, eight demonstrated partial response, 24 had stable disease (no progression after two cycles), 25 had progressive disease, and 11 did not have their disease progression completely evaluated. The median progression-free survival was 2.6 months and the median overall survival was 9.6 months.
Tasisulam was given in 21-day cycles using a dosing algorithm based on body weight. The most common grade 3/4 hematologic toxicities were thrombocytopenia (low platelet count), neutropenia (low white blood cell count) and anemia (low red blood cell count). Non-hematologic toxicities included fatigue, mucositis (inflammation of the mucous membrane) and stomatitis (inflammation of the mucous lining).
Tasisulam was granted orphan drug status for stage 2b-IV melanoma by the U.S. Food and Drug Administration in late 2009.
"Encouraging results from these studies are confirmation that Lilly Oncology is moving in the right direction towards finding innovative solutions for difficult-to-treat cancers," said Richard Gaynor, M.D., vice president, product development and medical affairs at Lilly Oncology. "These studies are in keeping with Lilly's dedication to addressing patient populations that are most in need."
In total, there will be 13 studies presented at ASCO evaluating Lilly pipeline molecules. Lilly has one of the largest oncology pipelines in the industry, with more than 20 molecules being evaluated for use in a wide range of cancers.
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