Health Canada approves Opdivo + Yervoy with chemo for metastatic non-small cell lung cancer.- BMS

BMS has announced 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. 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]).