Health Canada Approves OPDIVO® (nivolumab) plus YERVOY® (ipilimumab) Combined with Limited Chemotherapy for the Treatment of Metastatic Non-Small Cell Lung Cancer
MONTREAL, QUEBEC – August 11, 2020 – Today, Bristol Myers Squibb Canada (BMS) announces Health Canada’s approval of OPDIVO® (nivolumab) in combination with YERVOY® (ipilimumab) with two cycles of platinum-double chemotherapy for the treatment of patients with metastatic non-small cell lung cancer (NSCLC), with no Epidermal Growth Factor Receptor (EGFR) or Anaplastic Lymphoma Kinase (ALK) tumour aberrations and no prior systemic therapy for metastatic NSCLC.[i] Unlike traditional cancer therapies that target the tumour directly, immuno-oncology activates the body's own immune system to help recognize and attack cancer cells.[ii] This approval marks the availability of the first dual immuno-oncology plus limited course chemotherapy NSCLC treatment in Canada.
“Despite NSCLC being the most common form of lung cancer, every patient’s lung cancer and treatment journey is unique,” says Dr. Rosalyn Juergens, Associate Professor at McMaster University in the Department of Oncology, Division of Medical Oncology. “This approval provides a novel dual immuno-oncology-based option that may provide longer survival for patients within the Canadian treatment landscape.”
The Health Canada approval was based on results from the randomised phase III clinical trial CheckMate -9LA. The study met both its primary and key secondary endpoints, demonstrating superior overall survival (OS), progression-free survival (PFS) and overall response rate (ORR) for the dual immunotherapy plus limited chemotherapy combination versus chemotherapy alone.
Study results showed a statistically significant improvement in OS for metastatic NSCLC patients treated with OPDIVO®, YERVOY® and chemotherapy compared to chemotherapy alone at a prespecified interim analysis (at a minimum follow-up of 8.1 months, [HR 0.69; 96.71% CI: 0.55, 0.87; p=0.0006]).[iii] With longer follow-up (minimum of 12.7 months), the dual immunotherapy with two cycles of chemotherapy continued to show sustained overall survival (OS) improvements over chemotherapy alone (median OS of 15.6 months versus 10.9 months, respectively [HR: 0.66, 95% CI: 0.55 to 0.80]). 3
“Over four years ago, OPDIVO® became the first immunotherapy approved for use in previously treated patients, defining a new era and changing the way NSCLC is treated. We are so proud to build on this legacy as OPDIVO® plus YERVOY® is approved as the first dual immunotherapy in a first-line NSCLC setting,” said Al Reba, General Manager, BMS Canada. “We are committed to pursuing innovative approaches to lung cancer treatment so we can continue to deliver the right medicines for patients, increase their quality of life, and improve their chances of survival.”
“Receiving a diagnosis of advanced lung cancer is devastating,” says Shem Singh, Executive Director, Lung Cancer Canada. “We welcome this new Health Canada approval for a novel treatment regimen for patients where there is still significant unmet need.”
CheckMate -9LA Study Design
CheckMate -9LA (NCT03215706) is a Phase III, randomized open-label, multi-centre study evaluating OPDIVO® plus YERVOY® combined with two cycles of platinum-doublet chemotherapy versus chemotherapy (four cycles followed by optional pemetrexed maintenance therapy if eligible) as a first-line treatment in patients with metastatic or recurrent NSCLC regardless of PD-L1 expression and histology.
Health Canada and Project Orbis Collaboration Aims to Provide Earlier Availability to Cancer Treatments[iv]
Project Orbis is an initiative of the United States Food and Drug Administration (FDA) Oncology Center of Excellence. This submission was part of the FDA’s Project Orbis initiative, enabling concurrent review by the FDA and the health authorities in Australia, Canada and Singapore.
Pivotal clinical trials in oncology are commonly conducted internationally and these global trials are increasingly important for investigating the safety and effectiveness of cancer drugs for approval across jurisdictions. Future drug development may benefit by establishing a greater uniformity of new global standards of treatment, leading to the optimal design of these important trials.
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 more than 400 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.
Celgene and Juno Therapeutics are wholly owned subsidiaries of Bristol-Myers Squibb Company. In certain countries outside the U.S., due to local laws, Celgene and Juno Therapeutics are referred to as, Celgene, a Bristol Myers Squibb company and Juno Therapeutics, a Bristol Myers Squibb company.
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[i] Canadian Product Monograph. Revised August 6, 2020. https://www.bms.com/assets/bms/ca/documents/productmonograph/OPDIVO_EN_PM.pdf
[ii] Canadian Cancer Society. Immunotherapy. https://www.cancer.ca/en/cancer-information/diagnosis-and-treatment/chemotherapy-and-other-drug-therapies/immunotherapy/?region=on. Accessed May 26, 2020.
[iii] Reck M, Tudor-Eilade C, Cobo Dols M, et al. Nivolumab (NIVO) + ipilimumab (IPI) + 2 cycles of platinum-doublet chemotherapy (chemo) vs 4 cycles of chemo as first-line (1L) treatment (tx) for stage IV/recurrent non-small cell lung cancer (NSCLC): CheckMate 9LA [abstract]. In: American Society of Clinical Oncology (ASCO) Annual Meeting; May 29 – June 2, 2020; Virtual.
[iv] U.S. Food and Drug Administration. Project Orbis. https://www.fda.gov/about-fda/oncology-center-excellence/project-orbis. Accessed May 26, 2020.