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Pivotal Phase III Results Published for Zaltrap (Aflibercept) in Colorectal Cancer

Positive findings support FDA’s approval last August (Oct. 8)

Sanofi announced on October 8 that detailed results from the pivotal phase III VELOUR study evaluating Zaltrap (aflibercept) injection for intravenous infusion for the treatment of patients with previously treated metastatic colorectal cancer (mCRC) were published in the October edition of the Journal of Clinical Oncology.

Zaltrap is a recombinant fusion protein that binds to vascular endothelial growth factor (VEGF)-A, VEGF-B, and placental growth factor (PlGF). In the VELOUR trial, which evaluated mCRC patients previously treated with an oxaliplatin-containing regimen, Zaltrap in combination with the FOLFIRI (5-fluorouracil, leucovorin, and irinotecan) chemotherapy regimen showed a statistically significant improvement in overall survival, progression-free survival, and the overall tumor response rate versus placebo plus FOLFIRI.

The VELOUR trial data supported the FDA approval of Zaltrap on August 3, 2012 after a priority review. Zaltrap is approved in the US under the name ziv-aflibercept for use in combination with the FOLFIRI regimen in patients with mCRC that is resistant to or has progressed following an oxaliplatin-containing regimen.

The VELOUR trial showed that, in patients previously treated with an oxaliplatin-containing regimen, adding Zaltrap to FOLFIRI significantly improved median survival from 12.06 months to 13.50 months (hazard ratio [HR], 0.817; P = 0.0032) — an 18% relative risk reduction. A significant improvement in progression-free survival from 4.67 months to 6.90 months (HR, 0.758; P = 0.00007) — a 24% relative risk reduction — was also observed. The overall response rate in the Zaltrap-plus-FOLFIRI arm was 19.8% versus 11.1% for FOLFIRI plus placebo (P = 0.0001).

The most common adverse reactions reported at a higher incidence (a 2% or greater between-arm difference) in the Zaltrap-plus-FOLFIRI arm, in order of decreasing frequency, were leukopenia, diarrhea, neutropenia, proteinuria, aspartate aminotransferase (AST) increased, stomatitis, fatigue, thrombocytopenia, alanine aminotransferase (ALT) increased, hypertension, weight decreased, decreased appetite, epistaxis, abdominal pain, dysphonia, serum creatinine increased, and headache. The most common grade-3 or grade-4 adverse reactions reported at a higher incidence (a 2% or greater between-arm difference) in the Zaltrap-plus-FOLFIRI arm, in order of decreasing frequency, were neutropenia, diarrhea, hypertension, leukopenia, stomatitis, fatigue, proteinuria, and asthenia.

The phase III VELOUR study was a multinational, randomized, double-blind trial that compared the FOLFIRI regimen in combination with either Zaltrap or placebo in the treatment of patients with mCRC. The study randomized 1,226 patients with mCRC who had been treated with an oxaliplatin-containing regimen. The primary endpoint was an improvement in overall survival. Secondary endpoints included progression-free survival, overall response rate, and safety.

For more information, visit the Sanofi Web site.

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