Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that PD-L1 >= 1%, Wild type ALK, Wild type EGFR, Wild type ROS1 status confers therapeutic sensitivity to Carboplatin, Cemiplimab, Pemetrexed in patients with Non-Small Cell Lung Cancer.
The European Medicines Agency (EMA) has authorized cemiplimab in combination with platinum-based chemotherapy for the first-line treatment of adult patients with NSCLC expressing PD-L1 (in >= 1% of tumor cells), with no EGFR, ALK, or ROS1 aberrations. This indication is specifically for patients who have locally advanced NSCLC who are not candidates for definitive chemoradiation, or patients with metastatic NSCLC. This indication is based on Study 16113, a randomized, multi-center, double-blind, active-controlled trial. The chemotherapy used in this study consisted of either carboplatin or cisplatin in combination with paclitaxel or pemetrexed.
This statement is based on a regulatory approval from the European Medicines Agency:
LIBTAYO in combination with platinum_based chemotherapy is indicated for the first_line treatment of adult patients with NSCLC expressing PD-L1 (in >= 1% of tumour cells), with no EGFR, ALK or ROS1 aberrations, who have locally advanced NSCLC who are not candidates for definitive chemoradiation, or metastatic NSCLC.