Health Canada Approves OPDIVO^® (nivolumab) with Chemotherapy as Neoadjuvant Treatment for Adult Patients with Resectable Non-Small Cell Lung Cancer

MONTREAL, QUEBEC – August 23, 2022 – Today, Bristol Myers Squibb Canada (BMS) announced Health Canada’s approval of OPDIVO^® (nivolumab) 360 mg (injection for intravenous use) in combination with platinum-doublet chemotherapy every three weeks for three cycles for adult patients with resectable (tumors ≥4 cm or node positive) non-small cell lung cancer (NSCLC) in the neoadjuvant setting.[i]

“The approval of OPDIVO® plus platinum-doublet chemotherapy in the neoadjuvant setting represents a pivotal transformation in the way we can help patients with resectable non-small cell lung cancer,” said Dr Jonathan Spicer, Associate Professor of Surgery, Department of Surgery (Thoracic and Upper GI Surgery), McGill University. “As thoracic surgeons, despite our best efforts to completely remove lung cancers, we see our patients experience recurrence of their disease all too often. My goal is to cure cancer and this new pre-operative treatment combination is now shown to prolong survival and increase the number of patients who have no signs of cancer in their tissues after surgery.”

About Lung Cancer & Survival Rates

Lung cancer is the leading cause of cancer death for both males and females in Canada, accounting for over 25 percent of cancer deaths.ⁱⁱⁱ Non–small cell lung cancer (NSCLC) is the most common type of lung cancer making up more than 85 percent of all cases. ⁱⁱⁱ   

·         In NSCLC, 30 to 40 percent are resectable cancers, including most stage I–IIIa and a small proportion of stage IIIb lung cancers.[ii]  

·         For resectable NSCLC patients who undergo standard of care surgery, 30 to 45 percent will develop recurrence and die of their disease, despite resection.[iii]

“With the high rates of disease recurrence in patients with resectable NSCLC, this unique pre-operative treatment approach is very welcome news to our patient population,” said Shem Singh, Executive Director, Lung Cancer Canada. “This is an important step towards improving the lives of thousands of Canadians living with lung cancer today and in the future.

Clinical Data for Approval

The Health Canada NOC was based on CheckMate-816, which is a Phase 3, randomized, open label trial evaluating OPDIVO^® plus platinum-doublet chemotherapy compared to chemotherapy alone as neoadjuvant treatment in adult patients with resectable non-small cell lung cancer (NSCLC), regardless of PD-L1 expression. Published in the New England Journal of Medicine (NEJM), this study demonstrated that in patients with resectable NSCLC, treatment with neoadjuvant OPDIVO^® plus chemotherapy resulted in significantly longer event-free survival (EFS) and a higher percentage of patients with a pathological complete response (pCR) than chemotherapy alone.[iv]

“At BMS, we are driven to understand the complexities of cancer and are leveraging the latest science and technology to develop immunotherapies and combination therapies that push beyond what is currently available. Today’s approval is a demonstration to our multifaceted research approach,” said Troy André, General Manager, BMS Canada. “We are committed to offering patients the possibility of a better life through treatment options that can make a difference earlier in the course of their disease.”

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. Bristol Myers Squibb Canada Co. employs close to 300 people across the country. 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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For media requests please contact:

Rachel Yates
Corporate Affairs
Bristol Myers Squibb Canada
rachel.yates@bms.com

Tanvir Janmohamed
GCI Canada
613-404-3611
tanvir.janmohamed@gcicanada.com
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_{[i]Canadian Product Monograph. Accessed August 23, 2022.}

_{https://www.bms.com/assets/bms/ca/documents/productmonograph/OPDIVO_EN_PM.pdf}

_{[ii] Goldstraw, Peter et al. The IASLC Lung Cancer Staging Project: Proposals for Revision of the TNM Stage Groupings in the Forthcoming (Eighth) Edition of the TNM Classification for Lung Cancer. https://pubmed.ncbi.nlm.nih.gov/26762738/. Accessed June 14, 2022}

_{[iii] Carnio, Simona et al. Prognostic and predictive biomarkers in early stage non-small cell lung cancer: tumor based approaches including gene signatures. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4367732/. Accessed June 14, 2022.}

_{[iv] Forde, PM, Spicer, J et al. Neoadjuvant Nivolumab plus Chemotherapy in Resectable Lung Cancer. May 26, 2022}

_{N Engl J Med 2022; 386:1973-1985 https://www.nejm.org/doi/full/10.1056/NEJMoa2202170}