Ramucirumab improves overall survival in patients with metastatic colorectal cancer and could be an option in second-line therapy

• The RAISE study, published ahead of print in today´s online version of The Lancet Oncology, is a global Phase III trial evidencing that the use of the drug Ramucirumab (CYRAMZA®) combined with a type of chemotherapy (FOLFIRI) both significantly improves overall survival of patients with metastatic colorectal cancer whose disease progressed on standard first-line treatment, as well as slows disease progression.

• The Phase III trial, led by Josep Tabernero, Head of Medical Oncology Department of the Vall d’Hebron University Hospital and Director of the Vall d’Hebron Institute of Oncology (VHIO), shows that Ramucirumab could be an effective second-line therapy for patients with metastatic colorectal cancer.

• Colorectal cancer is the second most common tumor type worldwide, with an estimated incidence of more than 1.36 million new cases annually. Around 50% of patients with colorectal cancer develop metastases, which in many cases fail to respond to standard therapies.

Barcelona, April 13, 2015. The RAISE study, initiated in 2010, is a global, randomized, Phase III study that enrolled 1,072 patients across 24 countries in North and South America, Europe, Australia and Asia. The trial reported a significant improvement in the global survival of patients with metastatic colorectal cancer who were administered a combination of Ramucirumab and FOLFIRI — a type of chemotherapy (irinotecan, folinic acid and 5-fluorouracil), as second-line treatment. These patients had become resistant to standard first-line treatment for this disease.

Median global survival of patients treated with the combination of Ramucirumab and FOLFIRI was 13.3 months, ahead of 11.7 months for patients treated with placebo and FOLFIRI; reducing the risk of death by 16% and the risk of disease progression by 21%. The former combination was also shown to be effective across all tumor subgroups, including patients with KRAS wild-type and KRAS mutant tumors.

“Unresectable metastatic colorectal cancer is basically an incurable disease and is particularly difficult to treat after initial therapy stops working,”affirms Josep Tabernero, Head of the Medical Oncology Department at the Vall d’Hebron University Hospital and Director of VHIO, who led the RAISE study. “The RAISE study includedpatients with fast-growing tumors, so the findings are relevantto patientswe typically encounter in practice.”

He continues,“The RAISE trial results are very encouraging as they clearly demonstrate that sustained inhibition of the angiogenesis pathway from first-line to second-line metastatic colorectal cancer improves survival in a clinically-representative metastatic colorectal cancer population, including patients with poor prognosis.”

Data from the RAISE trial have been submitted to the regulatory authorities in the USA and the EU.

About Ramucirumab (CYRAMZA®)

Ramucirumab is an antiangiogenic therapy. It is a vascular endothelial growth factor (VEGF) Receptor 2 antagonist that specifically binds and blocks activation of VEGF Receptor 2 by blocking the binding of VEGF receptor ligands VEGF-A, VEGF-C, and VEGF-D. Ramucirumab inhibited angiogenesis in an in vivo animal model.

There are several studies underway to investigate ramucirumab as a single agent and in combination with other anti-cancer therapies for the treatment of multiple tumor types. To-date, Ramucirumab has been shown to be effective in four positive Phase III trials. These studies have evidenced that Ramucirumab prolongs survival in gastric cancer, lung cancer and colorectal cancer.

About Colorectal Cancer

Colorectal cancer rates second as the most common type of cancer globally, with an estimated incidence of more than 1.36 million new cases annually. It is calculated that this tumor type claims 694,000 lives worldwide each year, accounting for 8.5% of all cancer deaths ranking as the fourth most common cause of death from cancer. Almost 55% of colorectal cancer cases are diagnosed in developed regions around the world, and incidence and mortality rates are considerably higher in men than in women.


For more information please contact: Amanda Wren, Director of Communication, Vall d´Hebron Institute of Oncology (VHIO), Tel: +34 695207886, Email: awren@vhio.net

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