Merck: EMD Serono, Pfizer Canada receive approval for BAVENCIO™ from Health Canada

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

MISSISSAUGA, ON, 26-Feb-2018 — /EuropaWire/ — Merck, which operates as EMD Serono in the US 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 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

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, which provides new hope for patients and their loved ones.”

The Health Canada approval of BAVENCIOis 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 human IgG1 anti-PD-L1 blocking antibody. BAVENCIO was discovered by Merck and is co-developed by EMD Serono, the Biopharmaceutical business of Merck in the US and Canada, and Pfizer Canada Inc.

About Merck

Merck 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 generated sales of € 15.0 billion in 66 countries.

Founded in 1668, Merck is the world’s oldest pharmaceutical and chemical company. The founding family remains the majority owner of the publicly listed corporate group. Merck, Darmstadt, Germany holds the global rights to the “Merck” name and brand except in the United States and Canada, where the company operates as EMD Serono, MilliporeSigma 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).

For further information:

Samantha Ouimet
EMD Serono, Canada
905-919-0296
samantha.ouimet@emdserono.com

Manon Genin
Pfizer Canada Inc.
1-866-9PFIZER (973-4937)
Manon.Genin@pfizer.com

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: Merck KGaA