SuperGen Reports Results of Rescue Study With Orathecin Versus 5-FU

SuperGen has reported results from a Phase III study of Orathecin versus 5-FU in pancreatic cancer patients with progressive disease following treatment with gemcitabine.

The randomized, multinational, open-label study enrolled 224 patients. Key patient eligibility criteria included pathologic diagnosis of pancreatic cancer, progressive disease on gemcitabine, Karnofsky Performance Status of greater than 50, and life expectancy of more than two months. The primary endpoint was overall survival.

Orathecin (rubitecan capsules) was administered at 1.5 mg/m2 orally five days a week. 5-FU was administered at 600 mg/m2 intravenously once weekly. Patients who progressed or experienced intolerable toxicity could crossover to the alternate treatment arm. In the study, 41 percent of 5-FU patients crossed over to rubitecan rescue. The main reasons for rescue with rubitecan were radiologic or symptomatic progression on 5-FU.

Median survival was longer for patients who crossed over from 5-FU to rubitecan rescue compared to patients who did not crossover from 5-FU (184 versus 66 days). Of the 93 patients who crossed over to rubitecan, 35 were evaluable for tumor response assessment and had follow-up scans after the initiation of rubitecan rescue. In the evaluable group, 14 of 35 patients achieved tumor growth control (four showed objective tumor responses and 10 had disease stabilization.)

The most common Grade 3/4 adverse events with rubitecan were myelotoxicity and gastrointestinal. All deaths on study were primarily related to disease progression. The results demonstrate that patients with refractory/resistant pancreatic cancer, who have progressed on gemcitabine and 5-FU, can derive benefit from rubitecan, an oral medication that can be taken at home with manageable toxicity.