Sanofi US (EURONEXT: SAN and NYSE: SNY) announced today results of the pivotal SAVE-ONCO study which demonstrated that, in cancer patients initiating a chemotherapy regimen, investigational semuloparin significantly reduced the risk of the composite of symptomatic-deep vein thromboembolism (DVT), non-fatal pulmonary embolism (PE) or venous thromboembolism (VTE)-related death by 64%, meeting the study primary endpoint (respectively 1.2% and 3.4% for semuloparin and placebo HR 0.36 95% CI (0.21-0.60)), p< 0.0001). Semuloparin reduced the risk of this type of blood clots without increasing the incidence of major bleeding over placebo (1.2% vs. 1.1%). The SAVE-ONCO study results were presented today in an oral presentation at the 47th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago, and are selected for the Best of ASCO.
In VTE, blood clots usually form in deep veins (commonly referred as thrombo-phlebitis) and can migrate and potentially block blood flow in the blood vessels of the lungs (pulmonary embolism), which may result in sudden death. Often clinically silent, VTE is a life-threatening complication of cancer affecting up to one in five patients, and initiating chemotherapy further increases the risk by more than 60%.
"For cancer patients initiating chemotherapy, there is currently no approved treatment for the primary prevention of venous thrombo-embolism risk," said Giancarlo Agnelli, Professor of Medicine at the University of Perugia, Italy and SAVE-ONCO principal study investigator. "Therefore, we are encouraged by the 64% risk reduction of Life-Threatening Venous Blood Clots demonstrated in this randomized trial."
"In many patients affected by cancer, preventing venous thromboembolism is an important clinical management issue," said Dr. Elias Zerhouni, President, Global Research & Development, Sanofi. "We are pleased with the results achieved in this study of our selectively engineered semuloparin as shown by the SAVE-ONCO trial. Based on these results of SAVE-ONCO we plan to submit semuloparin for regulatory filing in Q3 2011."
SAVE-ONCO, the international randomized Phase III study enrolled 3,212 patients initiating a chemotherapy regimen for locally advanced or metastatic solid tumor (lung, colon-rectum, stomach, ovary, pancreas or bladder cancer). Patients received either a daily 20 mg subcutaneous administration of semuloparin or placebo for at least three months or until change in the chemotherapy regimen. The primary endpoint of the study was the composite of any symptomatic-DVT, non-fatal PE and VTE-related death. Clinically relevant bleeding (bleedings requiring medical attention) was respectively 2.8% and 2.0% for semuloparin and placebo. Consistent with previous findings, there was no case of reported HIT (heparin induced thrombocytopenia) in the 3,212 studied patients. SAVE-ONCO study median treatment duration with semuloparin was approximately 3.5 months.