OPDIVO® Receives Two New Health Canada Approvals for: Use with Chemotherapy for the Treatment for Patients with HER2 Negative Advanced or Metastatic Gastric, Gastroesophageal Junction or Esophageal Adenocarcinoma Cancers; Use as Monotherapy for the Adjuvant Treatment for Patients with Completely Resected Esophageal or Gastroesophageal Junction Cancers

MONTREAL, Nov. 2, 2021 /CNW/ - Today Bristol Myers Squibb Canada announces two recent Health Canada approvals for OPDIVO^® (nivolumab). Unlike traditional cancer therapies that target tumours directly, OPDIVO^® activates the body's own immune system to help recognize and attack cancer cells. 

On October 28, 2021, Health Canada approved OPDIVO^® for the treatment of HER2 negative advanced or metastatic gastric cancer, gastroesophageal junction cancer or esophageal adenocarcinoma (GC/GEJC/EAC), in combination with fluoropyrimidine and platinum- containing chemotherapy.ⁱ This approval was based on the results of the CheckMate -649 clinical trial, and represents a potential new standard of care for the first-line treatment of HER2 negative patients with advanced or metastatic gastric, gastroesophageal junction or esophageal adenocarcinoma.ⁱⁱ

Earlier this year, on July 2, 2021, Health Canada also approved OPDIVO^® as an adjuvant treatment of completely resected esophageal or gastroesophageal junction cancer in patients who have residual pathologic disease following prior neoadjuvant chemoradiotherapy (CRT).ⁱⁱⁱ  This approval was based on the results of the CheckMate -577 clinical trial and represents the possibility of extending the lives of patients with completely resected esophageal cancers and gastroesophageal junction cancers.^iv

"Stomach and esophageal cancers are some of the deadliest cancers, and there have been no major treatment advancements in many years," says Dr. Elena Elimova, Medical Oncologist at Princess Margaret Cancer Centre, and an investigator in the CheckMate -649 and Checkmate -577 clinical studies. "Time is of the essence for these patients and the addition of nivolumab as a treatment option provides an opportunity to potentially extend their lives."

"For many years, there had been a significant unmet medical need for these patients. These two approvals provide important new treatment options for patients facing a devastating diagnosis of stomach or esophageal cancer," said Teresa Tiano, Chair and Co-Founder, My Gut Feeling - Stomach Cancer Foundation of Canada.

About Gastrointestinal Cancers

• Esophageal Cancer: In Canada, the two most common types of esophageal cancer are adenocarcinoma and squamous cell carcinoma, which account for approximately 80% and 20% of all esophageal cancers, respectively.^v The five-year survival for patients diagnosed with esophageal cancer is approximately 16%, placing this cancer just behind mesothelioma and pancreatic cancer with one of the lowest survival rates.^vi In 2020, approximately 2,400 Canadians were diagnosed with esophageal cancer.^vii     
• Stomach Cancer: Stomach cancer, also known as gastric cancer, is a cancer that originates in the stomach. Stomach cancer begins as a malignant tumour in cells of the stomach but can spread, or metastasize, to other parts of the body.^viii Last year in Canada, approximately 4,200 Canadians were diagnosed with stomach cancer, and almost 2,000 died from the disease.^ix In Canada, the five-year net survival for patients diagnosed with stomach cancer is 25%, meaning the majority of those diagnosed with gastric cancer will not survive beyond five years.^x

"We never give up searching for the next innovation that could lead to opportunities for patients who are urgently seeking new treatment options," said Troy André, General Manager, BMS Canada. "Building on a legacy across a broad range of cancers that have changed survival expectations for many, these approvals reinforce our commitment to transforming patients' lives and delivering innovative treatment options."

About CheckMate -649^xi
Checkmate -649 is a Phase 3 randomized, multi-center, open-label study evaluating OPDIVO^® plus chemotherapy compared to chemotherapy alone in patients with previously untreated, non-HER2-positive, advanced, or metastatic gastric cancer, gastroesophageal junction cancer or esophageal adenocarcinoma. In the trial of this patient population, OPDIVO^® plus chemotherapy demonstrated superior overall survival (OS) compared to chemotherapy alone, both in all randomized patients, as well as in patients with PD-L1 combined positive score (CPS) ≥ 5. OPDIVO^® is the first PD-1 inhibitor to demonstrate superior OS and PFS in combination with chemotherapy versus chemotherapy alone in previously untreated patients with advanced metastatic gastric cancer, gastroesophageal junction cancer or esophageal adenocarcinoma. 

About CheckMate -577^xii
CheckMate -577 is a Phase 3 randomized, multi-center, double-blind study evaluating OPDIVO^® compared to placebo in esophageal or GEJ cancer patients with residual pathologic disease following neoadjuvant CRT and complete resection. The trial met its primary endpoint of disease-free survival demonstrating that adjuvant OPDIVO^® offers patients a chance to delay or potentially prevent disease recurrence. 

About Bristol Myers Squibb Canada Co.
Bristol 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, please visit https://www.bms.com/ca/en.

About Bristol Myers Squibb
Bristol 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 at BMS.com or follow us on LinkedIn, Twitter, YouTube, Facebook, and Instagram.

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^i	Canadian Product Monograph. Revised October 28, 2021.
^ii	Kelly RJ, Ajani JA, Kuzdzal J, et al. Adjuvant Nivolumab in Resected Esophageal or Gastroesophageal Junction Cancer. N Engl J Med. 2021;384:1191-203.
^iii	Canadian Product Monograph. Revised July 12, 2021. https://www.bms.com/assets/bms/ca/documents/productmonograph/OPDIVO_EN_PM.pdf
^iv	Janjigian Y, Shitara S, Moehler M, et al. First-line nivolumab plus chemotherapy versus chemotherapy alone for advanced gastric, gastro-esophageal junction, and esophageal adenocarcinoma (Checkmate 649): a randomized, open-label, phase 3 trial. The Lancet. 2021;398;27-40.
^v	Kelly RJ, Ajani JA, Kuzdzal J, et al. Adjuvant Nivolumab in Resected Esophageal or Gastroesophageal Junction Cancer. N Engl J Med. 2021;384:1191-203.
^vi	Statistics Canada. Cancer survival statistics, 2020 update. Available at https://www150.statcan.gc.ca/n1/daily-quotidien/201127/dq201127b-eng.htm. Accessed Oct. 6. 2021.
^vii	Canadian Cancer Society. Esophageal cancer statistics. Available at https://cancer.ca/en/cancer-information/cancer-types/esophageal/statistics. Accessed Oct. 6, 2021.
^viii	Canadian Cancer Society. What is stomach cancer. Available at https://cancer.ca/en/cancer-information/cancer-types/stomach/what-is-stomach-cancer. Accessed Oct. 6. 2021.
^ix	Canadian Cancer Society. Stomach cancer statistics. Available at https://cancer.ca/en/cancer-information/cancer-types/stomach/statistics. Accessed Oct. 6. 2021.
^x	Canadian Cancer Society. Survival statistics for stomach cancer. Available at https://www.cancer.ca/en/cancer-information/cancer-type/stomach/prognosis-and-survival/survival-statistics/?region=on.  Accessed Oct. 6, 2021.
^xi	Janjigian Y, Shitara S, Moehler M, et al. First-line nivolumab plus chemotherapy versus chemotherapy alone for advanced gastric, gastro-esophageal junction, and esophageal adenocarcinoma (Checkmate 649): a randomized, open-label, phase 3 trial. The Lancet. 2021;398;27-40.
^xii	Kelly RJ, Ajani JA, Kuzdzal J, et al. Adjuvant Nivolumab in Resected Esophageal or Gastroesophageal Junction Cancer. N Engl J Med. 2021;384:1191-203.

SOURCE Bristol Myers Squibb

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