Positive Study 16113 results have led the FDA to grant approval to to cemiplimab in combination with chemotherapy for the treatment of patients with advanced non–small cell lung cancer.
The FDA has granted approval to cemiplimab-rwlc (Libtayo) in combination with platinum-based chemotherapy for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with no EGFR, ALK, or ROS1 aberrations, according to an FDA announcement.1
Approval of cemiplimab for this indication is based on results from a randomized, multicenter, multinational, double-blind, active-controlled (Study 16113; NCT03409614). In the study cemiplimab in combination with platinum-based chemotherapy achieved a statistically significant and clinically meaningful improvement in overall survival (OS) vs placebo plus chemotherapy (HR, 0.71; 95% CI, 0.53-0.93], two-sided P =0.0140). The median OS was 21.9 months (95% CI, 15.5 to not evaluable) in the cemiplimab plus chemotherapy arm compared with 13.0 months (95% CI, 11.9-16.1) in the placebo plus chemotherapy arm. Cemiplimab/chemotherapy also demonstrated positive results for the secondary end points of progression-free survival (PFS) and overall response rate (ORR).
Study 16113 included 466 patients with who in the experimental arm received treatment every 3 weeks for 4 cycles followed by cemiplimab and maintenance chemotherapy. Patients in the control arm were given placebo plus platinum-based chemotherapy every 3 weeks for 4 cycles followed by placebo and maintenance chemotherapy.
In terms of PFS, the median per blinded independent committee review (BICR) was 8.2 months (95% CI: 6.4-9.3 months) in the cemiplimab/chemotherapy arm vs 5.0 months (95% CI: 4.3-6.2 months) in the placebo plus chemotherapy arm (HR, 0.56; 95% CI, 0.44-0.70, P <0.0001). the confirmed ORR per BICR in the cemiplimab arm was 43% (95% CI: 38-49) compared with 23% (95% CI: 16-30) in the placebo arm.
Safety results show that the most common adverse events (AEs) were alopecia, musculoskeletal pain, nausea, fatigue, peripheral neuropathy, and decreased appetite. These AEs occurred in more than 15% of patients in the study.
Based on the efficacy and safety shown with cemiplimab plus chemotherapy in the study, the FDA recommends administering cemiplimab intravenously at 350 mg every 3 weeks.
FDA approves cemiplimab-rwlc in combination with platinum-based chemotherapy for non-small cell lung cancer. News release. FDA.gov. November 8, 2022. Accessed November 8, 2022. https://bit.ly/3zZZie0