SuperGen, Inc. has completed the pre-specified interim analysis of the Orathecin (rubitecan) capsules phase II clinical trial studying Orathecin plus gemcitabine as first-line combination therapy for advanced pancreatic cancer patients who have not undergone chemotherapy. The multi-centre trial enrolled 39 patients with primary advanced pancreatic cancer. Patients received 1000 mg/m2 gemcitabine every week for three out of four weeks with concurrent 1.5 mg/m2 Orathecin given daily for five of the seven days each week. The cycle was repeated every four weeks until progression or patient withdrawal.
According to the company release, this protocol included a prospectively defined interim analysis (to be conducted after half of the patients had died) to estimate median survival. The analysis result is an estimated median survival of 6.0 months, with a Kaplan-Meier one-year survival to be 27%. Although the estimated one-year survival is encouraging compared to similar studies in this indication, the study did not meet the pre-specified threshold for median survival in order to proceed to a phase III randomized study. The safety profile for this patient group was very similar to prior studies of Orathecin as a single agent or in combination with gemcitabine. The study will remain closed to enrolment, but open for patient follow-up.
"We are working with our clinical advisors, investigators and potential partners to evaluate the best options for Orathecin that will maximize this product's potential to help patients in need and realize its commercial value for our stockholders," said James S. Manuso, President and Chief Executive Officer.
Orathecin (rubitecan) Capsules, an orally active camptothecin, is a topoisomerase I inhibitor that is being developed for the treatment of pancreatic cancer.
Orathecin has Orphan Drug status in both the US and EU. The Orathecin phase III clinical program is believed to be the largest program in pancreatic cancer ever initiated worldwide, with more than 1,800 patients. Orathecin has also been evaluated in numerous other cancers and blood disorders, stated the release.