The Food and Drug Administration ( FDA ) has approved Libtayo ( Cemiplimab-rwlc, Cemiplimab ) for the first-line treatment of patients with advanced non-small cell lung cancer ( NSCLC ) ( locally advanced who are not candidates for surgical resection or definitive chemoradiation or metastatic ) whose tumors have high PD-L1 expression ( Tumor Proportion Score [ TPS ] more than 50% ) as determined by an FDA-approved test, with no EGFR, ALK or ROS1 aberrations.
Efficacy was evaluated in Study 1624, a multi-center, randomized, open-label trial in 710 patients with locally advanced NSCLC who were not candidates for surgical resection or definitive chemoradiation or with metastatic NSCLC.
Patients were randomized ( 1:1 ) to receive Cemiplimab-rwlc 350 mg intravenously every 3 weeks for up to 108 weeks or a Platinum-based chemotherapy.
The main efficacy outcome measures were overall survival ( OS ) and progression-free survival ( PFS ) per blinded independent central review ( BICR ).
The trial has demonstrated statistically significant improvements in overall survival and progression-free survival for patients receiving Cemiplimab-rwlc compared to those treated with Platinum-based chemotherapy.
Median overall survival was 22.1 months ( 95% CI:17.7, NE ) for patients in the Cemiplimab-rwlc arm compared with 14.3 months ( 95% CI: 11.7, 19.2 ) in the chemotherapy arm ( hazard ratio, HR 0.68; 95% CI: 0.53, 0.87, p=0.0022 ).
Median progression-free survival per BICR was 6.2 months ( 4.5, 8.3 ) in the Cemiplimab-rwlc arm and 5.6 months ( 4.5, 6.1 ) in the chemotherapy arm ( HR 0.59; 95% CI: 0.49, 0.72, p less than 0.0001 ).
Confirmed overall response rate ( ORR ) per BICR was 37% ( 95% CI: 32, 42 ) and 21% ( 95% CI: 17, 25 ) in the Cemiplimab-rwlc and chemotherapy arms, respectively.
The most common adverse reactions ( more than 10% ) with Cemiplimab-rlwc as a single agent in Study 1624 were musculoskeletal pain, rash, anemia, fatigue, decreased appetite, pneumonia and cough.
The recommended Cemiplimab-rwlc dose for treatment of non-small cell lung cancer is 350 mg every 3 weeks, intravenously over 30 minutes. ( Xagena )
Source: FDA, 2021