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FDA approves sunitinib for pancreatic neuroendocrine tumors

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Sunitinib malate has received FDA approval as the first anti-VEGF therapy to treat progressive, well-differentiated pancreatic neuroendocrine tumors in patients with unresectable locally advanced or metastatic disease, according to a press release.

The FDA approval is based on data from the SUN 1111 pivotal phase 3 trial that demonstrated sunitinib malate (Sutent, Pfizer) provided a clinically significant improvement in PFS compared with placebo (10.2 vs. 5.4 months; P=0.000146). Treatment also yielded a statistically significant improvement in tumor response, with an objective response rate of 9.3% (95% CI; 3.2-15.4; P=0.0066). No objective responses were observed with placebo. In addition, while OS was not mature at the time of final analysis, nine deaths were observed in the treatment arm vs. 21 deaths in the placebo arm.

"This approval is welcome news for physicians who have struggled to find a treatment option that shows a substantial clinical benefit in treating advanced pancreatic NET," Eric Raymond, MD, professor of medical oncology and head of University Department of Medical Oncology (Service Inter Hospitalier de Cancerologie) Bichat-Beaujon, Clichy, France and investigator of the SUN 1111 trial, said in a press release. "Pancreatic NET is a highly vascular tumor, and as the first anti-VEGF therapy approved for this disease, Sutent represents a treatment that attacks a key component of tumor growth."

SUN 1111 was a multicenter, international, randomized, double-blind, placebo-controlled phase 3 study (n=171) evaluating single-agent sunitinib malate in 171 patients with unresectable pancreatic NET, characterized by cancer that could not be surgically removed. The primary endpoint was PFS. Other endpoints included OS, ORR and safety. Somatostatin analogs were permitted in the study, according to a press release.

Drug approval was based on assessment of PFS observed in SUN 1111. Previously reported data from the trial, published in the New England Journal of Medicine, showed the drug more than doubled median PFS compared with placebo (11.4 vs. 5.5 months; P<0.0001), which="" was="" found="" to="" be="" consistent="" in="" a="" blinded,="" independent="" central="" review="" of="" scans="" from="" the="" study="" (12.6="" vs.="" 5.8="" months;="">P=0.000015).

In February 2009, the independent Data Monitoring Committee for the SUN 1111 trial recommended that randomization to the study be stopped early in the interest of patient safety and based on the likelihood that the study would meet its primary endpoint if continued to completion, according to the release.

Sutent has been approved for advanced pancreatic NET in Europe and nine additional countries. It is also approved in more than 100 countries for both gastrointestinal stromal tumors after disease progression on, or intolerance to, imatinib mesylate, and advanced renal cell carcinoma.

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