SuperGen’s Orathecin increases survival in phase III rescue study

The randomized multinational open-label study enrolled 224 patients and the primary endpoint was overall survival. In the trial Orathecin (rubitecan) was administered at 1.5mg/m2 orally five days/week. 5-FU was administered at 600mg/m2 intravenously once weekly. Patients who progressed or experienced intolerable toxicity could crossover to the alternate treatment arm.

In the study 41% of 5-FU patients crossed over to rubitecan rescue. The main reasons for rescue with rubitecan were radiologic (75%) and symptomatic (12%) 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, 38% were evaluable for tumor response assessment and had follow-up scans after the initiation of rubitecan rescue. In the evaluable group, 40% of patients achieved tumor growth control.

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.

Orathecin has orphan drug status in both the US and EU for the treatment of pancreatic cancer. The Orathecin European filing contains data from a phase III clinical program believed to be the largest program in pancreatic cancer ever initiated worldwide, with more than 1,000 patients. The drug has also been evaluated in numerous other cancers and blood disorders.