Ontario joins Quebec, Manitoba and Saskatchewan in the decision to fund GAZYVA® (obinutuzumab) for patients with the most common form of leukemia¹

Targeted treatment will be funded in Ontario for patients with Chronic Lymphocytic Leukemia

MISSISSAUGA, ON, July 23, 2015 /CNW/ - People in Ontario living with Chronic Lymphocytic Leukemia (CLL) will now be able to access a new treatment option through the province's prescription drug insurance plan. GAZYVA^® (obinutuzumab) in combination with chlorambucil chemotherapy was added to Cancer Care Ontario's New Drug Funding Program (NDFP). This decision follows announcements made on June 2, 2015 that GAZYVA would be funded in Quebec, and on July 6, 2015 that it would be funded in Manitoba and Saskatchewan.

"We are encouraged to hear about the Minister of Health's decision to make GAZYVA available to CLL patients living in Ontario," said Mr. Ronnie Miller, President and CEO, Roche Canada. "Roche is committed to ensuring that patients have access to medications, and we are pleased that four provinces have now included GAZYVA on their formularies."

CLL is the most common form of adult leukemia, with nearly 2,200 Canadians diagnosed each year.^2,3 It is an incurable, slow-growing cancer of the blood and bone marrow.⁴ Since the average age of diagnosis for CLL is 72 years, nearly 90 per cent of patients are living with at least one comorbidity (e.g., cardiac disease, diabetes or respiratory disease), which may be associated with their age and lifestyle, potentially limiting their treatment options.⁵

CLL is a blood cancer that causes "B-lymphocyte" cells to multiply too quickly and live too long. GAZYVA works by binding to the surface of these cells, causing them to die.⁶

GAZYVA was approved by Health Canada on November 25, 2014, in combination with chlorambucil, for the treatment of patients with previously untreated CLL.⁷ The treatment is now funded in Manitoba, Saskatchewan, Quebec and Ontario but continues to be under review in all other Canadian provinces.

About GAZYVA
GAZYVA is a monoclonal antibody designed to bind to CD20, a protein found on white blood cells called B cells. It attacks targeted cells both directly and together with the body's immune system. GAZYVA was designed by Roche Glycart AG, a wholly-owned, independent research unit of Roche and is the first medicine approved under the U.S. Food and Drug Administration's (FDA) Breakthrough Drug designation.⁸ GAZYVA is also approved as a first-line treatment for CLL by the European Commission under the brand name GAZYVARO™.

Health Canada's approval of GAZYVA is based on results from the pivotal Phase III CLL11 trial, which was a multicenter, open-label, randomized three-arm study enrolling 781 patients with previously untreated CLL and co-existing medical conditions.

The CLL11 trial was conducted in cooperation with the German CLL Study Group (GCLLSG) and investigated the efficacy, as well as safety profile of either GAZYVA plus chlorambucil or RITUXAN^® (rituximab) plus chlorambucil compared to chlorambucil alone. The trial showed that people who received GAZYVA in combination with chlorambucil significantly reduced the risk of disease progressions or death by 84 per cent compared to chlorambucil alone (HR=0.16; p<0.0001). GAZYVA also more than doubled the time people with newly diagnosed CLL lived without the disease getting worse (median progression-free survival (PFS): 23.0 months vs. 11.1 months). Approximately one in five patients (or 22 per cent) receiving GAZYVA in combination with chlorambucil achieved a complete response (CR), which is the disappearance of all signs of cancer in response to treatment.⁹

The most common Grade 3/4 adverse events for those who received GAZYVA in combination with chlorambucil compared to chlorambucil alone were infusion-related reactions during the first infusion (21 per cent vs. 0 per cent [chlorambucil is an oral medicine]), low platelet count (thrombocytopenia, 11 per cent vs. 3 per cent) and low count of certain types of white blood cells (neutropenia, 34 per cent vs. 16 per cent).¹⁰

About Roche
Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world's largest biotech company, with truly differentiated medicines in oncology, infectious diseases, inflammation, metabolism and neuroscience. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Roche's personalized healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2012 Roche had over 82,000 employees worldwide and invested over 8 billion Swiss francs in R&D. The Group posted sales of 45.5 billion Swiss francs. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.

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References

^1	The Leukemia and Lymphoma Society of Canada. Disease information and support. http://www.llscanada.org/diseaseinformation/getinformationsupport/factsstatistics/leukemia/. Accessed on July 17, 2015.
^2	The Leukemia and Lymphoma Society of Canada. Disease information and support. http://www.llscanada.org/diseaseinformation/getinformationsupport/factsstatistics/leukemia/. Accessed on July 17, 2015.
^3	Canadian Cancer Society. Chronic Lymphocytic Leukemia. Chronic lymphocytic leukemia statistics. https://www.cancer.ca/en/cancer-information/cancer-type/leukemia-chronic-lymphocytic-cll/statistics/?region=on. Accessed July 17, 2015.
^4	Canadian Cancer Society. Chronic Lymphocytic Leukemia. Disease progression of chronic lymphocytic leukemia. https://www.cancer.ca/en/cancer-information/cancer-type/leukemia-chronic-lymphocytic-cll/diseaseprogression/?region=on. Accessed on July 17, 2015.
^5	Thurmes P, Call T, Slager S, et al. Comorbid conditions and survival in unselected, newly diagnosed patients with chronic lymphocytic leukemia. Leuk Lymphoma. 2008;49(1):49-56.
^6	GAZYVA^®Product Monograph. November 25, 2014.
^7	GAZYVA^®Product Monograph. November 25, 2014.
^8	U.S. Food and Drug Administration. (2013). FDA approves Gazyva for chronic lymphocytic leukemia [Press release]. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm373209.htm. Accessed on July 17, 2015.
^9	Goede V, Fischer K, Busch R, et al. Obinutuzumab plus Chlorambucil in Patients with CLL and Coexisting Conditions. N Engl J Med. 2014 Mar 20;370(12):1101-10.
^10	GAZYVA^®Product Monograph. November 25, 2014.

SOURCE Roche Canada

Kate Hanna, Roche Canada, 905-285-7729 , [email protected]; Alexa Vogel, Edelman, 416-850-0387, [email protected]