Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that PD-L1 >= 50%, Wild type ALK, Wild type EGFR, Wild type ROS1 status confers therapeutic sensitivity to Cemiplimab in patients with Non-Small Cell Lung Cancer.
This statement is based on a regulatory approval from the Health Canada:
LIBTAYO (cemiplimab for injection) is indicated as monotherapy for the first-line treatment of adult patients with non-small cell lung cancer (NSCLC) expressing PD-L1 in ≥ 50% of tumour cells (Tumour Proportion Score [TPS] ≥ 50%), as determined by a validated test, with no EGFR, ALK or ROS1 aberrations, who have locally advanced NSCLC who are not candidates for surgical resection or definitive chemoradiation, or metastatic NSCLC.