Sanofi’s Investigational Semuloparin in Cancer Patients Initiating Chemotherapy Shows a 64 % Risk Reduction in Life-Threatening Venous Thrombo-Embolism
– Results of Phase III SAVE-ONCO Study Selected for “Best of ASCO 2011″ -
– Venous Thrombo-embolism Affects Up to 1 in 5 Cancer Patients And
Chemotherapy Further Increases this Risk
Sanofi (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%[i], 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 will be presented on
in an oral presentation at the 47th Annual Meeting of the American Society of
Clinical Oncology (ASCO) in
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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 [ii]. Often clinically silent, VTE is a life-threatening complication
of cancer affecting up to one in five patients[iii], [iv], and initiating
chemotherapy further increases the risk by more than 60%[v],[vi].
“For cancer patients initiating chemotherapy, there is currently no
approved treatment for the primary prevention of venous thrombo-embolism
risk,” said
University of Perugia,
“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.
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 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 VTE-related deathi. Clinically relevant
bleeding (bleedings requiring medical attention) was respectively 2.8% and
2.0% for semuloparin and placeboi . 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 monthsi.
* The 2011 Best of ASCO Meetings feature the most relevant and
cutting-edge science in oncology research.
About Semuloparin
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. Selectively engineered semuloparin, in
addition to a specific anti-Factor Xa/IIa ratio, retains biological
activities that are relevant in cancer biology such as effects on TFPI
(tissue factor pathway inhibitor)[vii]. A large Phase III clinical study
(SAVE-ONCO) investigating semuloparin benefit in cancer patients with locally
advanced or metastatic solid tumor initiating chemotherapy has been
completed. The SAVE-ONCO study assessed the efficacy and safety of
semuloparin for the prevention of symptomatic- DVT, non-fatal Pulmonary
Embolism and VTE-related death in cancer patients initiating a chemotherapy
regimen.
About Sanofi Oncology
Based in
dedicated to translating science into effective cancer therapeutics to
address unmet medical needs for patients with cancer. Starting with a deep
understanding of the mechanisms by which cancer develops, grows and spreads,
the company employs innovative approaches in drug discovery, clinical
development and partnerships to bring the right medicines to the right
patients with the goal of helping cancer patients live healthier and longer
lives.
Sanofi 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 investigational compounds in
clinical development including small molecules and biological agents.
About Sanofi
Sanofi, a global and diversified healthcare leader, discovers, develops
and distributes therapeutic solutions focused on patients’ needs. Sanofi has
core strengths in the field of healthcare with seven growth platforms:
diabetes solutions, human vaccines, innovative drugs, rare diseases, consumer
healthcare, emerging markets and animal health. Sanofi is listed in
(EURONEXT: SAN) and in
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[i] Agnelli G et al. ASCO
[ii] Heit AJ. Risk factors for venous thromboembolism. Clin Chest Med.
2003 Mar; 24 (1): 1-12.
[iii] Lyman GH. Venous Thromboembolism in the Patient With Cancer. Cancer
2011; 1334-50.
[iv] Khorana AA et al. Thromboembolism is a leading cause of death in
cancer patients receiving outpatient chemotherapy . J Thromb Haemost
2007;5:632-4.
[v] Heit JA. Cancer and Venous Thromboembolism: Scope of the Problem.
Cancer Control.
[vi] Heit JA et al. Risk Factors for Deep Vein Thrombosis and Pulmonary
Embolism. Arch Intern Med 2000 ;160:809-15.
[vii] Gómez-Outes A et al. New parenteral anticoagulants in development.
Ther Adv Cardiovasc Dis 2011 5: 33-59.
SOURCE Sanofi