Sanofi presents benefits of semuloparin; Zaltrap improves colorectal cancer survival

French drug major Sanofi (Euronext: SAN) announced results at the American Society of Clinical Oncology (ASCO) meeting in Chicago 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% versus 1.1%). 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, the company explains. 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 Internal 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,” he noted.