Advanced NSCLC Monotherapy Treatment

Subgroup Analysis:
Baseline characteristics

Approved in patients with advanced NSCLC* with PD-L1 ≥50% and no EGFR, ALK, or ROS1 aberrations1

Analysis of overall survival by subgroups2

Limitations:

OS subgroup analyses were not powered to show a statistically significant difference between or within individual subgroups. Furthermore, histology, brain metastases at baseline, and cancer stage at screening were not prespecified subgroup analyses. Firm conclusions cannot be made based on these subgroup analyses.

ITT population (N=710)
Events, n (total) HR (95% CI)
LIBTAYO Chemotherapy
Overall
108 (356) 141 (354) 0.68 (0.53-0.87)
Age
<65 years 61 (200) 71 (190) 0.72 (0.51-1.02)
≥65 years 47 (156) 70 (164) 0.63 (0.43-0.91)
Sex
Male 93 (312) 123 (294) 0.64 (0.49-0.84)
Female 15 (44) 18 (60) 0.87 (0.42-1.78)
Region of enrollment
Europe 85 (275) 119 (278) 0.62 (0.47-0.82)
Asia 10 (39) 8 (38) 1.34 (0.52-3.42)
Rest of the world 13 (42) 14 (38) 0.73 (0.34-1.56)
ECOG PS
0 25 (96) 32 (96) 0.78 (0.46-1.32)
1 83 (260) 109 (258) 0.66 (0.49-0.88)
Histology
Squamous 45 (159) 65 (152) 0.53 (0.36-0.77)
Nonsquamous 63 (197) 76 (202) 0.83 (0.59-1.16)
Brain metastases at baseline
Yes 9 (44) 15 (39) 0.44 (0.19-1.07)
No 99 (312) 126 (315) 0.71 (0.54-0.92)
Cancer stage at screening
Locally advanced 17 (63) 16 (52) 0.85 (0.43-1.68)
Metastatic 91 (293) 125 (302) 0.68 (0.52-0.89)
0.1 1 10 LIBTAYO better Chemotherapy better
  • Adapted with permission from Sezer et al, Lancet 2021 supplementary appendix.1
  • *Patients with locally advanced NSCLC who are not candidates for surgical resection or definitive chemoradiation or who have metastatic NSCLC.1

In an analysis of the subset of patients with advanced NSCLC* who had no EGFR, ALK, or ROS1 aberrations and known PD-L1 ≥50% (n=563):

Post hoc analysis of overall survival by subgroups1

Limitations:

OS subgroup analyses were not powered to show a statistically significant difference between or within individual subgroups. Furthermore, none of the subgroup analyses were prespecified in the subset of patients with known PD-L1 ≥50%. Firm conclusions cannot be made based on these subgroup analyses.

Known PD-L1 ≥50% population (n=563)
Events, n (total) HR (95% CI)
LIBTAYO Chemotherapy
Overall
70 (283) 105 (280) 0.57 (0.42-0.77)
Age
<65 years 41 (157) 50 (147) 0.66 (0.44-1.00)
≥65 years 29 (126) 55 (133) 0.48 (0.30-0.76)
Sex
Male 58 (248) 92 (231) 0.50 (0.36-0.69)
Female 12 (35) 13 (49) 1.11 (0.49-2.52)
Region of enrollment
Europe 55 (215) 84 (216) 0.54 (0.39-0.77)
Asia 5 (31) 7 (29) 0.76 (0.24-2.41)
Rest of the world 10 (37) 14 (35) 0.59 (0.26-1.33)
ECOG PS
0 18 (77) 23 (75) 0.77 (0.41-1.44)
1 52 (206) 82 (205) 0.54 (0.38-0.76)
Histology
Squamous 30 (122) 48 (121) 0.48 (0.30-0.77)
Nonsquamous 40 (161) 57 (159) 0.64 (0.43-0.96)
Brain metastases at baseline
Yes 4 (34) 12 (34) 0.17 (0.04-0.76)
No 66 (249) 93 (246) 0.60 (0.44-0.83)
Cancer stage at screening
Locally advanced 9 (45) 15 (42) 0.48 (0.20-1.14)
Metastatic 61 (238) 90 (238) 0.59 (0.43-0.82)
0.1 1 10 LIBTAYO better Chemotherapy better
  • Adapted with permission from Sezer et al, Lancet 2021 supplementary appendix.1
  • *Patients with locally advanced NSCLC who are not candidates for surgical resection or definitive chemoradiation or who have metastatic NSCLC.1

References: 1. LIBTAYO (cemiplimab-rwlc) injection full U.S. prescribing information. Regeneron Pharmaceuticals, Inc., and sanofi-aventis U.S. LLC. 2. Sezer A, Kilickap S, Gümüş M, et al. Cemiplimab monotherapy for first-line treatment of advanced non-small-cell lung cancer with PD-L1 of at least 50%: a multicentre, open-label, global, phase 3, randomised, controlled trial. Lancet. 2021;397(10274)(suppl):1-178.

Reference: 1. Sezer A, Kilickap S, Gümüş M, et al. Cemiplimab monotherapy for first-line treatment of advanced non-small-cell lung cancer with PD-L1 of at least 50%: a multicentre, open-label, global, phase 3, randomised, controlled trial. Lancet. 2021;397(10274):592-604.