Cyramza™ is first biologic to demonstrate survival benefit in second-line for gastric cancer
TORONTO, Sept. 21, 2015 /CNW/ - Eli Lilly Canada announced today that its new gastric cancer medicine, Cyramza™ (ramucirumab), has been approved and is now available for use in Canada. Cyramza was authorized by Health Canada for use as a single agent or in combination with paclitaxel for the treatment of patients with advanced or metastatic gastric cancer or gastro-esophageal junction adenocarcinoma with disease progression on or after prior platinum and fluoropyrimidine chemotherapy1.
In Canada, an estimated 3,400 new cases of gastric cancer are expected to be diagnosed in 20152, gastric cancer offers few discernible symptoms until the disease has reached an advanced stage3,4.
Consequently, patients are often diagnosed late in the progression of the disease, yielding poor outlooks for most patients5. In Canada, the five-year relative survival ratio is sixth-worst of all cancers, at approximately 25 percent2,5.
"A diagnosis of gastric cancer changes your life forever," says Teresa Tiano, gastric cancer survivor and advocate. "It can take you to a dark place where you feel frightened and alone. Patients need to be assured that they are not alone, that they have support from their medical team, their family and friends, and from other gastric cancer patients and survivors."
"Developing medications for gastric cancer, and spreading awareness through organizations like Debbie's Dream Foundation, empower patients and caregivers with hope - a critical tool for people on their cancer journeys," adds Ekaterina Kosyachkova, gastric cancer survivor and advocate.
"Cyramza is the first biologic drug targeting the formation of new blood vessels that has demonstrated a statistically significant survival benefit in the treatment of this serious form of cancer," noted Dr. Christine Brezden-Masley, a medical oncologist at St. Michael's Hospital. "Stomach cancer is difficult to diagnose and the prognosis for many patients is poor, especially in Western countries where we tend to find it later than they do in some parts of Asia, for example. As a result, the availability in Canada of a new treatment specifically indicated for second-line use is a valuable treatment for patients with this disease."
Cyramza is a human vascular endothelial growth factor receptor 2 antagonist and is administered as an IV solution by infusion. Clinical studies, including the RAINBOW and REGARD phase 3 trials, demonstrated Cyramza's efficacy and manageable side effect profile as a second-line therapy for gastric cancer1,6,7.
"We're very pleased and proud that Cyramza is now available to Canadian patients and oncologists," said Prentice Stovall, Oncology Business Unit Leader, Eli Lilly Canada. "There is a high unmet medical need in patients with gastric cancer. By expanding the number of treatment options available to oncologists and cancer patients, through ongoing discovery and continuous innovation, Lilly's researchers and collaborators are helping advance the science and improve health outcomes for people diagnosed with cancer."
About Gastric (Stomach) Cancer
Gastric cancer, a malignancy arising from the lining of the stomach, is the fourth-most common cancer in the world, and is the second-leading cause of death worldwide6. In Canada, an estimated 3,400 new cases of gastric cancer are expected to be diagnosed in 2015. Signs and symptoms are vague, non-specific, and rarely evident until the disease has reached an advanced stage. As a result, these cancers have very low rates of cure at diagnosis. Mortality is high: while it is the 11th and 16th most common cancer in Canadian males and females, respectively, it is the 9th and 10th most common cause of death in Canadian males and females respectively2. The 5-year relative survival ratio is 6th-worst at approximately 25% from time of diagnosis2,5.
Cyramza is a vascular endothelial growth factor (VEGF) Receptor 2 antagonist that belongs to a group of biologic substances called monoclonal antibodies. In order to grow, tumours require oxygen and nutrients which are delivered through the blood. As tumours grow, they require larger amounts of oxygen and nutrients. Tumours get this supply by inducing the growth of new blood vessels, a process called angiogenesis. Cyramza works by blocking angiogenesis and helps starve the tumour of oxygen and other nutrients. Cyramza is not chemotherapy; it is considered a biologic antiangiogenic therapy1 .
The most common adverse reactions observed in Cyramza (ramucirumab)-treated patients are: fatigue/asthenia, neutropenia, leukopenia, diarrhea, epistaxis, and hypertension. Clinically relevant reactions (including Grade >3) associated with antiangiogenic therapy observed in Cyramza-treated patients across clinical trials were proteinuria, infusion-related reactions, and gastrointestinal perforations1.
About the RAINBOW trial
RAINBOW was a global, Phase 3, multi-centre, randomized, double-blind study of Cyramza plus paclitaxel versus placebo plus paclitaxel that randomized (1:1) 665 patients with locally advanced or metastatic gastric cancer (including adenocarcinoma of the GEJ) who previously received platinum- and fluoropyrimidine-containing chemotherapy, with or without anthracycline. The primary endpoint was overall survival and the secondary endpoints included progression free survival and overall response rate1.
About the REGARD trial
REGARD was a global, Phase 3, multi-centre, randomized, double-blind study of Cyramza plus best supportive care (BSC) versus placebo plus BSC that randomized (2:1) 355 patients with locally advanced or metastatic gastric cancer (including adenocarcinoma of the GEJ) who previously received platinum- or fluoropyrimidine-containing chemotherapy. The primary endpoint was overall survival and secondary endpoints included progression-free survival (PFS) and 12-week PFS rate1.
About Lilly Oncology
For more than fifty years, Lilly has been dedicated to delivering life-changing medicines and support to people living with cancer and those who care for them. Lilly is determined to build on this heritage and continue making life better for all those affected by cancer around the world.
Lilly is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by Colonel Eli Lilly, who was committed to creating high quality medicines that meet people's needs, and today we remain true to that mission in all our work. Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and contribute to our communities through philanthropy and volunteerism.
About Lilly Canada
Eli Lilly Canada was established in 1938, the result of a research collaboration with scientists at the University of Toronto which eventually produced the world's first commercially-available insulin. Lilly Canada now employs more than 500 people across the country, working in the areas of oncology, cardiovascular and endocrine disorders, men's and women's health, autoimmunity, neuroscience and diabetes. To learn more about Lilly Canada, please visit us at http://www.lilly.ca
1 Cyramza Product Monograph, July 16, 2015
2 Canadian Cancer Statistics, 2015
3 American Cancer Society, "Learn About Cancer: Stomach Cancer," Updated: January 18, 2012; http://www.cancer.org/Cancer/StomachCancer/index, (Accessed: August 27, 2012).
4 http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2690660/#!po=0.568182 Accessed September 16, 2015
5 http://www.cancer.ca/en/cancer-information/cancer-type/stomach/prognosis-and-survival/survival-statistics/?region=on Accessed September 16, 2015
6 Fuchs CS, Tomasek J, Yong CJ, Dumitru F, Passalacqua R, Goswami C, Safran H, dos Santos LV, Aprile G, Ferry DR, Melichar B, Tehfe M, Topuzov E, Zalcberg JR, Chau I, Campbell W, Sivanandan C, Pikiel J, Koshiji M, Hsu Y, Liepa AM, Gao L, Schwartz JD, Tabernero J; REGARD Trial Investigators. Ramucirumab monotherapy for previously treated advanced gastric or gastro-oesophageal junction adenocarcinoma (REGARD): an international, randomised, multicentre, placebo-controlled, phase 3 trial. Lancet. 2014 Jan 4;383(9911):31-9.
7 Wilke H, Muro K, Van Cutsem E, et al. Ramucirumab plus paclitaxel versus placebo plus paclitaxel in patients with previously treated advanced gastric or gastro-oesophageal junction adenocarcinoma (RAINBOW): a double-blind, randomised phase 3 trial. The Lancet Oncology 2014; 15(11): 1224-35 http://dx.doi.org/10.1016/S1470-2045(14)70420-6
SOURCE Eli Lilly Canada
Image with caption: "Eli Lilly Canada Inc. (CNW Group/Eli Lilly Canada)". Image available at: http://photos.newswire.ca/images/download/20150921_C6169_PHOTO_EN_501097.jpg
For further information: including video, visit www.lilly.ca or contact: Michael McDougall, Director, Communications, Eli Lilly Canada Inc., 416-693-3474 (office), 647-226-3066 (mobile); Abby Radovski, Thornley Fallis, 416-515-7517 x328