Eli Lilly said that the Phase II study 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.
Reportedly, 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.
Lilly added that Tasisulam was given in 21-day cycles using a dosing algorithm based on body weight. Tasisulam was granted orphan drug status for stage 2b-IV melanoma by the FDA in late 2009.
John Kirkwood, co-leader of the melanoma program of the University of Pittsburgh Cancer Institute, said: “Ongoing research is critical if we are to find appropriate treatments for patients who need them most.”
Richard Gaynor, vice president of product development and medical affairs at Lilly Oncology, said: “Encouraging results from these studies are confirmation that Lilly Oncology is moving in the right direction towards finding solutions for difficult-to-treat cancers.”