Health Canada Approves OPDIVO® (nivolumab) plus YERVOY® (ipilimumab) Combined with Limited Chemotherapy for the Treatment of Metastatic Non-Small Cell Lung Cancer

MONTREAL, Aug. 11, 2020

MONTREAL, Aug. 11, 2020 /CNW/ - 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.¹  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.² 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]).³ 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."