Pfizer reports the first positive Phase III results in a long time for its anticancer agent Sutent. Patients with advanced pancreatic islet cell tumors treated with the compound had a median progression-free survival (PFS) of 11.1 months compared to those on placebo who had a PFS of 5.5 months.
This trial was stopped earlier this year, Pfizer says, after the Data Monitoring Committee recommended doing so, because they found that Sutent showed significant benefit and the study met its primary endpoint.
Sutent is an oral multikinase inhibitor currently approved for advanced renal cell carcinoma and second-line gastrointestinal stromal tumor. Pfizer is studying the compound in a slew of solid tumor settings in the hopes of expanding the label.
Evaluations of Sutent in two advanced breast cancer settings, however, failed to show improvements and have been stopped. These Phase III studies looked at Sutent in combination with paclitaxel as a first-line treatment of advanced breast cancer and Sutent alone in patients with advanced breast cancer who had failed standard treatment.
The success in the late-stage advanced pancreatic islet cell tumor study thus marks a departure from the trend of Sutent failures. The trial compared the drug to placebo in patients with progressive, well-differentiated, malignant pancreatic islet cell tumors who had progressed in the last 12 months. Patients were randomized to either the Sutent (n=75; 37.5 mg/day, continuous daily dosing) plus best supportive care arm or placebo plus best supportive care arm (n=79).
The most commonly reported grade 3–4 adverse events in the Sutent arm were neutropenia (12.3%), hypertension (8.8%), abdominal pain (7%), diarrhea (7%), hypoglycemia (7%), and hand-foot syndrome (7%).