Health Canada Approves BAVENCIO™ (Avelumab for Injection) for the Treatment of Metastatic Merkel Cell Carcinoma (MCC) in Previously Treated Adult Patients

First Health Canada approved treatment for rare and aggressive type of skin cancer

MISSISSAUGA, ON, Feb. 22, 2018 /CNW/ - EMD Serono, Canada, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany in the U.S. and Canada, and Pfizer Canada Inc. announced that Health Canada has approved BAVENCIO™ (avelumab for injection) for the treatment of metastatic Merkel cell carcinoma (MCC) in previously treated adults. Reviewed under Health Canada's accelerated approval framework, BAVENCIO was granted a Notice of Compliance with Conditions (NOC/c) based on tumour response and durability of response on December 18, 2017.¹ BAVENCIO, a fully human anti-PD-L1 antibody, is the first Health Canada approved treatment for patients with metastatic MCC, a rare and aggressive type of skin cancer.²

Roger Deckert, an 81-year old grandfather from Edmonton, Alberta is one of the 5 to 12 per cent of MCC patients in Canada who presented with metastatic disease at the time of diagnosis.^4,10,6,3

"When I was diagnosed in late 2014, I underwent two years of traditional treatments, as there were no other treatment options," says Roger Deckert. "I'm grateful for this approval and new hope that this has given me for a brighter future with my family and friends. I applaud that this treatment is now available to other patients in Canada living with this debilitating disease."

People living with metastatic MCC face a very poor prognosis.² Fewer than half of metastatic MCC patients will survive more than one year, and fewer than 20 per cent will survive beyond five years.³

"Merkel cell carcinoma is an aggressive form of skin cancer associated with very poor outcomes, particularly once the disease has metastasized," says Dr. John Walker, Oncologist, Cross Cancer Institute. "This approval represents an important breakthrough for metastatic MCC patients and their healthcare teams, who until now had no options beyond chemotherapy or enrolment in clinical trials."

It is estimated that there are approximately 290 people in Canada with MCC (based on estimated U.S. incidence rates and a Canadian population of 36.26 million).^4,5

Access to New Therapeutic Option Urgently Needed
"Canadians living with metastatic MCC are in urgent need of access to new therapeutic options to treat their aggressive disease – they simply don't have the luxury of time," says Kathy Barnard, Founder, Save Your Skin Foundation. "We applaud Health Canada's approval of BAVENCIO, which provides new hope for patients and their loved ones."

The Health Canada approval of BAVENCIO is based on results of the JAVELIN Merkel 200 trial, an open-label, single-arm, multi-centre phase II study conducted in 88 patients with metastatic MCC whose disease had progressed after at least one chemotherapy treatment for distant metastatic disease. Patients were treated at a dose of 10 mg/kg every two weeks until disease progression or unacceptable toxicity. The primary efficacy analysis in this study was confirmed best overall response and the key secondary efficacy analysis was duration of response. The efficacy analysis was conducted when the last patient enrolled had completed 12 months of follow-up.

BAVENCIO is part of a class of immunotherapy drugs called checkpoint inhibitors. It is a fully human IgG1 anti-PD-L1 blocking antibody. BAVENCIO was discovered by Merck KGaA, Darmstadt, Germany and is co-developed by EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany in the US and Canada, and Pfizer Canada Inc.

About EMD Serono, Canada
EMD Serono, Canada, is the Canadian biopharmaceutical business of Merck KGaA, Darmstadt, Germany. EMD Serono, Canada has integrated cutting-edge science, innovative products and devices, and industry-leading patient support and access programs. EMD Serono, Canada has deep expertise in neurology, fertility and endocrinology, as well as a robust pipeline of potential therapies in neurology, oncology, immunology and immuno-oncology. Today, EMD Serono, Canada has more than 100 employees across Canada with headquarters in Mississauga, Ontario.

About Merck KGaA, Darmstadt, Germany
Merck KGaA, Darmstadt, Germany is a leading science and technology company in healthcare, life science and performance materials. Around 50,000 employees work to further develop technologies that improve and enhance life – from biopharmaceutical therapies to treat cancer or multiple sclerosis, cutting-edge systems for scientific research and production, to liquid crystals for smartphones and LCD televisions. In 2016, Merck KGaA, Darmstadt, Germany generated sales of € 15.0 billion in 66 countries.

Founded in 1668, Merck KGaA, Darmstadt, Germany, is the world's oldest pharmaceutical and chemical company. The founding family remains the majority owner of the publicly listed corporate group. Merck KGaA, Darmstadt, Germany, holds the global rights to the Merck name and brand. The only exceptions are the United States and Canada, where the company operates as EMD Serono, Millipore Sigma and EMD Performance Materials.

About Pfizer Canada Inc.
Pfizer Canada Inc. is the Canadian operation of Pfizer Inc., one of the world's leading biopharmaceutical companies. Our diversified health care portfolio includes some of the world's best known and most prescribed medicines and vaccines. Historically, Pfizer Inc. has invested more than US $7 billion toward developing safe and effective medicines. At Pfizer, we're working together for a healthier world. To learn more about Pfizer Canada, visit pfizer.ca or you can follow us on Twitter (twitter.com/PfizerCA) or Facebook (facebook.com/PfizerCanada).

References

1.	BAVENCIO™ Product Monograph. December 18, 2017.
2.	Nasseri, E. Merkel Cell Carcinoma. Canadian Family Physcican. 2012: 58(9):967-969. Available at: http://www.cfp.ca/content/58/9/967#ref-8
3.	Lemos B., et al. Pathologic Nodal Evaluation Improves Prognostic Accuracy in Merkel Cell Carcinoma: Analysis of 5,823 Cases as the Basis of the First Consensus Staging System for this Cancer. Journal of the American Academy of Dermatology. 2010;63:751–761.
4.	Fitzgerald T., et al. Dramatic Increase in the Incidence and Mortality from Merkel Cell Carcinoma in the United States. The American Journal of Surgery. 2015: 81(8): 802-806.
5.	Statistics Canada. Population by year, by province and territory. Available at: http://www.statcan.gc.ca/tables-tableaux/sum-som/l01/cst01/demo02a-eng.htm Accessed December 2017.
6.	Allen PJ., Bowne W., Jaques D., et al. Merkel cell carcinoma: prognosis and treatment of patients from a single institution. Journal of Clin Oncology. 2005;23(10):2300-2309.
7.	Andea A., Coit D., Amin B., et al. Merkel cell carcinoma: histologic features and prognosis. Cancer 2008;113(9):2549-2558.
8.	Andea A., Patel R., Ponnazhagan S., et al. Merkel cell carcinoma: correlation of KIT expression with survival and evaluation of KIT gene mutational status. Human Pathology. 2010;41(10):1405-1412.
9.	Santamaria-Barria J., Boland G., Yeap B., et al. Merkel cell carcinoma: 30-year experience from a single institution. Annals of Surgical Oncology. 2013;20(4):1365-1373.
10.	Stokes JB, Graw KS, Denel LT, et al. Patients with Merkel cell carcinoma tumors < or = 1.0 cm in diameter are unlikely to harbor regional lymphnode metastasis. Journal of Clinical Oncology. 2009;27(23):3772-3777.

SOURCE EMD Serono

Samantha Ouimet, EMD Serono, Canada, 905-919-0296, [email protected]; Manon Genin, Pfizer Canada Inc., 1-866-9PFIZER (973-4937), [email protected]