The international, Phase 3 trial compared sunitinib with placebo in patients with progressive, well-differentiated, malignant pancreatic neuroendocrine tumors. In the study the patients were randomised to either the sunitinib (37.5mg/day, continuous daily dosing) plus best supportive care arm or the placebo plus best supportive care arm.
The study results showed that median progression-free survival (PFS) was 11.4 months in patients treated with sunitinib compared with 5.5 months in patients treated in the placebo arm. Sutent also prolonged overall survival, a secondary endpoint of the trial.
Reportedly, an independent Data Monitoring Committee (DMC) recommended halting the trial in February 2009 because sunitinib showed significant benefit and the primary endpoint was met.
Mace Rothenberg, senior vice president of clinical development and medical affairs of oncology business unit at Pfizer, said: “This trial advances our understanding of the use of novel targeted therapies in a patient population with limited treatment options. We are pleased to be working toward filling an unmet patient need, as we did with Sutent four years ago in patients with kidney cancer and gastrointestinal stromal tumors.”
The company said that the Phase 3 study findings served as the basis for the recent filings of supplemental applications for sunitinib in the treatment of pancreatic neuroendocrine tumors with the regulatory authorities in the US, Europe and Canada.