The treatment emergent adverse events (AEs) on the aflibercept arm with an incidence that was 10 percent greater than the control arm were stomatitis, weight decrease, hypertension, epistaxis and dysphonia. Grade 3 or 4 AEs that occurred at a frequency of at least 5 percent in patients who received aflibercept were fatigue, stomatitis, disease progression, hypertension, febrile neutropenia, dyspnea, neutropenia, and asthenia. AEs leading to treatment discontinuation occurred in 27.2 percent of patients in the aflibercept arm compared to 14.6 percent in the placebo arm. The types and frequencies of AEs reported in the aflibercept treatment arm were generally consistent with those reported in previous studies with anti-VEGF agents.
The companies will conduct a detailed analysis of the efficacy and safety results of the VITAL study. Full results will be presented at an upcoming medical meeting.
"Bringing new and innovative cancer therapies to patients can be incredibly challenging, especially in difficult-to-treat cancers such as second-line non-small cell lung cancer," said
About the VITAL Phase III Study
The VITAL study was a multinational, randomized, double-blind trial comparing aflibercept versus placebo in combination with docetaxel patients with locally advanced or metastatic non-squamous NSCLC who have failed one platinum-based therapy. The study enrolled 913 patients who were randomized to receive intravenous (IV) docetaxel 75 mg/m2 plus either IV placebo or IV aflibercept 6 mg/kg every three weeks until disease progression, unacceptable toxicity, patient's refusal or further treatment. The primary objective of the study was to demonstrate improvement in overall survival with the combination of aflibercept and docetaxel compared with placebo and docetaxel.
About the Aflibercept Clinical Development Program
Sanofi-aventis Oncology and Regeneron are collaborating on a broad oncology development program, combining the investigational agent aflibercept with common chemotherapy regimens in the treatment of patients with advanced cancers. In addition to VITAL, the program includes two Phase III trials and one Phase II trial, all of which are fully enrolled:
Aflibercept (VEGF Trap) is an investigational angiogenesis inhibitor with a unique mechanism of action. This fusion protein binds all forms of Vascular Endothelial Growth Factor-A (VEGF-A), as well as VEGF-B and placental growth factor (PIGF), additional angiogenic growth factors that appear to play a role in tumor angiogenesis and inflammation. Aflibercept has been shown to bind VEGF-A, VEGF-B and PlGF with higher affinity than their natural receptors.
About Non-Small Cell Lung Cancer (NSCLC)
According to the
About sanofi-aventis Oncology
Sanofi-aventis Oncology is committed to the pursuit of science and innovative cancer therapies. We believe in partnership with leading experts, and combining that expertise with our own internal scientific strength and heritage. There are currently more than 10 compounds in clinical development including small molecules and biological agents.
Sanofi-aventis, a leading global pharmaceutical company, discovers, develops and distributes therapeutic solutions to improve the lives of everyone. Sanofi-aventis is listed in
Regeneron is a fully integrated biopharmaceutical company that discovers, develops, and commercializes medicines for the treatment of serious medical conditions. In addition to ARCALYST® (rilonacept) Injection for Subcutaneous Use, its first commercialized product, Regeneron has therapeutic candidates in Phase III clinical trials for the potential treatment of gout, diseases of the eye (wet age-related macular degeneration and central retinal vein occlusion), and certain cancers. Additional therapeutic candidates developed from proprietary Regeneron technologies for creating fully human monoclonal antibodies are in earlier stage development programs in rheumatoid arthritis and other inflammatory conditions, pain, cholesterol reduction, allergic and immune conditions, and cancer. Additional information about Regeneron and recent news releases are available on Regeneron's web site at www.regeneron.com.
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