Health Canada Approves ONUREG (azacitidine tablets), First Maintenance Therapy for Patients in Remission from Acute Myeloid Leukemia – Canada NewsWire

AML is a heterogeneous clonal disorder characterized by immature myeloid cell proliferation and bone marrow failure, and is the most common form of acute leukemia in adults, accounting for approximately 80 per cent of adult cases.2,3,4 An estimated 40-60 per cent of patients aged 60 years and older and 60-80 per cent of patients under 60 years old will obtain complete remission through induction chemotherapy (IC); however, 50 per cent will relapse within a year.5,6 Once a relapse occurs, long-term survival averages at six months.7 In 2015, an estimated 1,235 Canadians were diagnosed with AML and the overall incidence rate in Canada is 3.46/100,000 people.8,9

"While the majority of patients with AML achieve a complete remission with intensive chemotherapy, many remission patients will experience disease relapse, especially if they were not eligible for a stem cell transplant. Until now, there has been no established standard of care for Canadians who are in remission from AML, but are not eligible for a stem cell transplant," noted Dr. Andre Schuh, Princess Margaret Cancer Centre, Toronto. "The approval of ONUREG is significant because it gives transplant ineligible patients with AML in remission a new treatment option that may improve their survival".

ONUREG is a nucleoside metabolic inhibitor that is taken orally and works by preventing cancer cells from growing. ONUREG becomes incorporated into the building blocks of cells (deoxyribonucleic acid (DNA) and ribonucleic acid (RNA)), which interferes with the production of new DNA and RNA. This is thought to kill cancerous cells in leukemia.10

"The approval of ONUREG is an extension of our ongoing commitment to Canadians living with blood cancer," said Al Reba, General Manager, Bristol Myers Squibb Canada. "We are proud that this therapy will help to fill a significant need for Canadians living in remission from AML and hope that it will have a positive impact on their everyday life."

Health Canada's approval of ONUREG is based upon findings from the QUAZAR AML-001 clinical trial. The QUAZAR study, a double-blind, randomized, placebo-controlled, multicenter Phase III study, involved adult patients 55 years or older living with AML. In the study, patients were randomized to Onureg or placebo within four months of achieving first CR/CRi following intensive induction chemotherapy and were not eligible for a stem cell transplant.11In the study, results showed the median overall survival (OS) was significantly longer with ONUREG versus placebo: 24.7 months versus 14.8 months [HR 0.69 (95% CI: 0.55, 0.86); p=0.0009], indicating a 31 per cent reduction in the risk of death in the ONUREG arm. Relapse-free survival (RFS), the key secondary endpoint in the study, supports the OS results. The median RFS was 10.2 months for ONUREG versus 4.8 months for placebo [HR 0.65 (95% CI: 0.52, 0.81); p=0.0001].12

About Bristol Myers Squibb CanadaBristol Myers Squibb Canada Co. is an indirect wholly-owned subsidiary of Bristol Myers Squibb Company, a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb global operations, visitwww.bms.com. Bristol Myers Squibb Canada Co. delivers innovative medicines for serious diseases to Canadian patients in the areas of cardiovascular health, oncology, and immunoscience. Bristol Myers Squibb Canada Co. employs close to 400 people across the country. For more information, please visitwww.bms.com/ca.

About Bristol Myers SquibbBristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us atBMS.comor follow us on LinkedIn, Twitter, YouTube, Facebookand Instagram.

References

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1 ONUREG Product Monograph, January 2021.

2 Saultz JN, Garzon R. J Clin Med 2016;5:33.

3Leukemia & Lymphoma Society of Canada. Acute Myeloid Leukemia. Available from https://www.llscanada.org/sites/default/files/National/CANADA/Pdf/InfoBooklets/AML%20Fact%20Sheet%2012-2019.pdf. Accessed December 11, 2020.

4De Kouchkovsky I, Abdul-Hay M. Blood Cancer J 2016;e441:DOI:10.1038/bcj.2016.50.

5Dohner et al. Blood. 2017;129(4):42447.

6SEER Cancer Statistics, 2007-2013.

7Xu J, et al. Medicine (Baltimore) 2018;97:e12102.

8Statistics Canada. Population estimates on July 1st, by age and sex. Available from https://www150.statcan.gc.ca/t1/tbl1/en/tv.action?pid=1710000501&pickMembers%5B0%5D=1.1&pickMembers%5B1%5D=2.1&cubeTimeFrame.startYear=2015&cubeTimeFrame.endYear=2016&referencePeriods=20150101%2C20160101. Accessed December 11, 2020.

9Shysh et al. BMS Public Health (2018) 18:94.

10ONUREG Product Monograph, January 2021.

11ONUREG Product Monograph, January 2021.

12 ONUREG Product Monograph, January 2021.

SOURCE Bristol Myers Squibb Canada Co.

For further information: For media requests, please contact: Rachel Yates, Lead, Corporate Affairs, Bristol Myers Squibb Canada, [emailprotected]; Alannah Nugent, Account Executive, Health, Edelman, [emailprotected]

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Health Canada Approves ONUREG (azacitidine tablets), First Maintenance Therapy for Patients in Remission from Acute Myeloid Leukemia - Canada NewsWire

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