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Afinitor and Sandostatin LAR Phase II data show advanced pancreatic NET patients remain progression-free for nearly 17 months

26 Jun 2009 - New data demonstrate that treatment with AfinitorŽ (everolimus) Tablets in combination with SandostatinŽ LARŽ (octreotide acetate suspension for injection) and Afinitor monotherapy may have the potential to control tumor growth in patients with advanced pancreatic neuroendocrine tumors (NET). These results will be presented at the 11th World Congress on Gastrointestinal Cancer in Barcelona, Spain.
 
RADIANT-1 (RAD001 In Advanced Neuroendocrine Tumors) is a Phase II study of 160 patients with pancreatic NET resistant to treatment with cytotoxic chemotherapy. The final analysis shows that patients who received Afinitor in combination with Sandostatin LAR, an approved treatment for symptom control in certain types of NET, remained progression-free for a median of 16.7 months, nearly four additional months since the first analysis was reported*[1],[2]. In addition, 84% of patients receiving combination therapy experienced a decrease in tumor size. Patients who took Afinitor monotherapy remained progression-free for 9.7 months and nearly 60% of patients experienced a decrease in tumor size.
 
"These final results from the RADIANT-1 trial demonstrate the potential of Afinitor to stabilize tumor growth for a prolonged period of time when used in combination with Sandostatin LAR or as monotherapy," said James Yao, MD, Associate Professor of Medicine at The University of Texas M.D. Anderson Cancer Center. "With limited options available to treat advanced pancreatic neuroendocrine tumors, these promising data suggest Afinitor may provide benefit in patients who experienced disease progression after chemotherapy."
 
Furthermore, the results of RADIANT-1 were evaluated to explore biomarkers that may help identify the patients most likely to benefit from treatment with Afinitor. An analysis of the study data showed that patients who demonstrated an early response on chromogranin A (CgA) and neuron-specific enolase (NSE) levels experienced longer time without disease progression compared to patients who did not have an early response on CgA and NSE levels. Further evaluation is ongoing in Phase III trials to determine the potential value of these biomarkers for determining optimal treatment options for patients with NET.