Advanced NSCLC Monotherapy Treatment

Efficacy
Overview

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

Efficacy in patients who received LIBTAYO in EMPOWER-Lung 11
 
ITT (N=710)
LIBTAYO
(n=356)
Chemotherapy
(n=354)
OS per BICR2
Median, months (95% CI)
22.1 (17.7-NE)
14.3 (11.7-19.2)
HR (95% CI)§
0.68 (0.53-0.87)
P-value
0.0022
Deaths, n (%)
108 (30)
141 (40)
Median, months (95% CI)
22.1 (17.7-NE)
14.3 (11.7-19.2)
HR (95% CI)§
0.68 (0.53-0.87)
P-value
0.0022
Deaths, n (%)
108 (30)
141 (40)
Median, months (95% CI)
6.2 (4.5-8.3)
5.6 (4.5-6.1)
HR (95% CI)§
0.59 (0.49-0.72)
P value
<0.0001
Events, n (%)
201 (57)
262 (74)
Median, months (95% CI)
6.2 (4.5-8.3)
5.6 (4.5-6.1)
HR (95% CI)§
0.59 (0.49-0.72)
P value
<0.0001
Events, n (%)
201 (57)
262 (74)
ORR, % (95% CI)
37 (32-42)
21 (17-25)
CR, %
3
1
PR, %
33
20
ORR, % (95% CI)
37 (32-42)
21 (17-25)
CR, %
3
1
PR, %
33
20
 
Median, months (range)
21.0 (1.9+-23.3+)
6.0 (1.3+-16.5+)
Median, months (range)
21.0 (1.9+-23.3+)
6.0 (1.3+-16.5+)
 
  • *Patients with locally advanced NSCLC who are not candidates for surgical resection or definitive chemoradiation or who have metastatic NSCLC.1
  • Investigator's choice: Paclitaxel + cisplatin or carboplatin; gemcitabine + cisplatin or carboplatin; or pemetrexed + cisplatin or carboplatin followed by optional pemetrexed maintenance in patients with nonsquamous histology.1
  • Based on Kaplan-Meier method.1
  • §Based on stratified proportional hazards model.1
  • ||Clopper-Pearson exact confidence interval.1
  • += Ongoing response;1 BICR=blinded independent central review; CR=complete response; DOR=duration of response; HR=hazard rates; ITT=intention to treat; ORR=overall response rate; OS=overall survival; PFS=progression free survival; PR=partial response.

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):

Efficacy in patients who received LIBTAYO in EMPOWER-Lung 11-3
 
Known PD-L1 ≥50% (n=563)
LIBTAYO
(n=283)
Chemotherapy
(n=280)
OS per BICR
Median, months (95% CI)
NR (17.9-NE)
14.2 (11.2-17.5)
HR (95% CI)§
0.57 (0.42-0.77)
P value
0.0002
Deaths, n (%)
70 (25)
105 (38)
Median, months (95% CI)
NR (17.9-NE)
14.2 (11.2-17.5)
HR (95% CI)§
0.57 (0.42-0.77)
P value
0.0022
Deaths, n (%)
70 (25)
105 (38)
Median, months (95% CI)
8.2 (6.1-8.8)
5.7 (4.5-6.2)
HR (95% CI)§
0.54 (0.43-0.68)
P value
<0.0001
Events, n (%)
147 (52)
197 (70)
Median, months (95% CI)
8.2 (6.1-8.8)
5.7 (4.5-6.2)
HR (95% CI)§
0.54 (0.43-0.68)
P value
<0.0001
Events, n (%)
147 (52)
197 (70)
ORR, % (95% CI)
39 (34-45)
20 (16-26)
CR, %
2
1
PR, %
37
19
ORR, % (95% CI)
39 (34-45)
20 (16-26)
CR, %
2
1
PR, %
37
19
 
Median, months (range)
16.7 (1.9+-23.3+)
6.0 (1.3+-14.5+)
Median, months (range)
16.7 (1.9+-23.3+)
6.0 (1.3+-14.5+)
 

The EMPOWER-Lung 1 study was designed to enroll patients with PD-L1 ≥50%.1

  • A total of 710 patients were enrolled and randomized. For some patients, it was later determined that PD-L1 biomarker testing was not conducted according to the instructions for use, and required retesting1
  • An analysis was conducted in a subset of patients with known PD-L1 ≥50% (n=563). The analysis excluded 91 patients from the overall population whose PD-L1 status was unknown because their tumors could not be retested, and 56 patients from the overall population who had <50% PD-L1 expression1 (LIBTAYO is not indicated in patients with <50% PD-L1 expression)

*Patients with locally advanced NSCLC who are not candidates for surgical resection or definitive chemoradiation or who have metastatic NSCLC.1

  • Investigator's choice: Paclitaxel + cisplatin or carboplatin; gemcitabine + cisplatin or carboplatin; or pemetrexed + cisplatin or carboplatin followed by optional pemetrexed maintenance in patients with nonsquamous histology.1
  • Based on Kaplan-Meier method.1,2
  • §Based on stratified proportional hazards model.3
  • ||Clopper-Pearson exact confidence interval.1
  • Not a prespecified endpoint in the 563-patient population with PD-L1 >50%.3
  • +:Ongoing response.2 BICR=blinded independent central review; CR=complete response; PR=partial response.

Explore the efficacy and
safety of LIBTAYO

Watch these videos featuring medical experts to learn more about the efficacy and safety profile of LIBTAYO and the clinical trial design of EMPOWER-Lung 1.

  • Top-line overview of EMPOWER-Lung 1 video thumbnail
    Top-line overview of EMPOWER-Lung 1
  • Detailed review of EMPOWER-Lung 1 video thumbnail
    Detailed review of EMPOWER-Lung 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):592-604.

References: 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. 2. PD-L1 IHC 22C3 pharmDx [instructions for use]. Carpinteria, CA: Dako, Agilent Pathology Solutions; 2021. 3. Data on file. Regeneron Pharmaceuticals, Inc. 4. 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.