Health Canada Approves Cemiplimab in Combination with Chemotherapy for First-line Treatment of Advanced NSCLC
On May 1, Health Canada issued a Notice of Compliance for cemiplimab-rwlc in combination with platinum-based chemotherapy for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC). This includes patients that have no EGFR, ALK, or ROS1 aberrations and whose tumors are metastatic or locally advanced and not candidates for definitive chemoradiation.
The Canadian decision follows a similar decision by the US Food and Drug Administration, which approved cemiplimab-rwlc in combination with platinum-based chemotherapy for adult patients with advanced NSCLC with no EGFR, ALK, or ROS1 mutations in November 2022. Both approvals were based on efficacy data from the EMPOWER-Lung 3 study.
The data showed cemiplimab-rwlc plus platinum-based chemotherapy demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) compared to placebo plus chemotherapy. Median OS was 21.9 months (95% CI: 15.5, not evaluable) in the cemiplimab-rwlc plus chemotherapy arm compared to 13.0 months (95% CI: 11.9, 16.1) in the placebo plus chemotherapy arm. Additionally, median progression free survival (PFS) was 8.2 months (95% CI: 6.4, 9.3) in the cemiplimab-rwlc plus chemotherapy arm and 5.0 months (95% CI: 4.3, 6.2) in the placebo plus chemotherapy arm. Confirmed overall response rate was 43% (95% CI: 38, 49) and 23% (95% CI: 16, 30) in the respective treatments.
Lung cancer is the most diagnosed cancer in Canada, excluding non-melanoma skin cancers, and is the leading cause of death from cancer for both men and women in Canada.1
WCLC Early Registrations Savings End June 9
Early registration for the 2023 World Conference on Lung Cancer, which will take place Sept. 9-12 in Singapore and virtually, ends soon. Register by June 9 to receive the discounted early registration rate. After June 9, regular registration continues through July 21.
The following ticketed sessions are available to in-person attendees for an additional fee:
- Meet the Expert Breakfast Sessions
- CT Screening Workshop
- IASLC Foundation Benefit Supporting Early Career Researchers
References
- 1. Canadian Cancer Society. Lung and bronchus cancer statistics. Accessed April 14, 2023.
