Date: 2011-06-04
Type of information:
phase: 3
Announcement: results
Company: Sanofi (France)
Product: semuloparin
Action mechanism: semuloparin is an investigational selectively engineered Ultra-LMWH (low molecular weight heparin) with enriched anti-thrombin binding sites, leading to anticoagulant activity mainly directed towards coagulation Factor Xa, with a minimal effect on Factor IIa.
Disease: venous thrombo-embolism (VTE) in cancer patients
Therapeutic area: Cancer - Oncology - Cardiovascular diseases
Country:
Trial details: SAVE-ONCO, the international randomized phase 3 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 VTErelated 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.
Latest
news: Sanofi has announced 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%) i. The SAVE-ONCO study results were presented 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.
Based on these results of SAVE-ONCO Sanofi plans to submit semuloparin for regulatory filing in Q3 2011.
