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FDA has approved Libtayo in combination with Platinum-based chemotherapy for non-small cell lung cancer


The Food and Drug Administration ( FDA ) has approved Libtayo ( Cemiplimab-rwlc; Cemiplimab ) in combination with Platinum-based chemotherapy for adult patients with advanced non-small cell lung cancer ( NSCLC ) with no EGFR, ALK, or ROS1 aberrations.

Efficacy was evaluated in Study 16113, a randomized, multicenter, multinational, double-blind, active-controlled trial in 466 patients with advanced NSCLC who had not received prior systemic treatment.
Patients were randomized ( 2:1 ) to either Cemiplimab plus Platinum-based chemotherapy every 3 weeks for 4 cycles followed by Cemiplimab and maintenance chemotherapy or placebo plus Platinum-based chemotherapy every 3 weeks for 4 cycles followed by placebo and maintenance chemotherapy.
The main efficacy outcome measure was overall survival ( OS ). Additional efficacy outcome measures were progression-free survival ( PFS ) and overall response rate ( ORR ) as assessed by blinded independent central review ( BICR ).

Cemiplimab plus Platinum-based chemotherapy has demonstrated a statistically significant and clinically meaningful improvement in overall survival compared to placebo plus chemotherapy ( hazard ratio [ HR ] of 0.71 [ 95% CI: 0.53, 0.93 ], two-sided p-value = 0.0140 ).
Median overall survival was 21.9 months ( 95% CI: 15.5, not evaluable ) in the Cemiplimab plus chemotherapy arm and 13.0 months ( 95% CI: 11.9, 16.1 ) in the placebo plus chemotherapy arm.
Median progression-free survival per BICR was 8.2 months ( 95% CI: 6.4, 9.3 ) in the Cemiplimab plus chemotherapy arm and 5.0 months ( 95% CI: 4.3, 6.2 ) in the placebo plus chemotherapy arm ( HR=0.56; 95% CI: 0.44, 0.70, p less than 0.0001 ).
Confirmed ORR per BICR was 43% ( 95% CI: 38, 49 ) and 23% ( 95% CI: 16, 30 ) in the respective treatments.

The most common ( 15% or more ) adverse reactions were alopecia, musculoskeletal pain, nausea, fatigue, peripheral neuropathy, and decreased appetite.

The recommended Libtayo dose is 350 mg IV every 3 weeks. ( Xagena )

Source: FDA, 2022

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