Advanced NSCLC Monotherapy Treatment

PFS AND RESPONSE
RATES

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

LIBTAYO significantly EXTENDED PROGRESSION-FREE SURVIVAL vs platinum-based
chemotherapy in EMPOWER-Lung 11,2

LIBTAYO vs platinum-based chemotherapy in EMPOWER-Lung 1 PROGRESSION FREE SURVIVAL DATA
  • Adapted with permission from Sezer et al, Lancet 2021 supplementary appendix.2
41%

Reduction in risk of progressive disease HR=0.59

(95% Cl, 0.49-0.72)
P<0.0001

Median PFS: 6.2 months
(95% CI, 4.5-8.3) with LIBTAYO vs 5.6 months (95% CI,
4.5-6.1) with chemotherapy1
  • Number of events: 57% of patients (201 out of 356 patients) with LIBTAYO and 74% of
    patients (262 out of 354 patients) with chemotherapy1
*Patients with locally advanced NSCLC who are not candidates for surgical resection or definitive chemoradiation or who have metastatic NSCLC.1
HR based on stratified proportional hazards model.1

ORR and DOR with LIBTAYO vs platinum-based chemotherapy in
EMPOWER-Lung 11

ITT population (N=710)

Objective response rate

  • 37% (95% CI, 32%-42%) (CR=3%, PR=33%) with LIBTAYO vs 21% (95% CI, 17%-25%) (CR=1%, PR=20%) with
    chemotherapy1

Duration of response

  • Median of 21 months (range, 1.9+-23.3+ months) with LIBTAYO vs 6 months (range, 1.3+-16.5+ months) with
    chemotherapy1
‡Clopper-Pearson exact confidence interval.1
+: Ongoing response.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):

Progression-free survival with LIBTAYO vs platinum-based chemotherapy in EMPOWER-Lung 11,2

Progression-free survival with LIBTAYO vs platinum-based chemotherapy in EMPOWER-Lung 1
  • Adapted with permission from Sezer et al, Lancet 2021.1
46%

Reduction in risk of progressive disease HR=0.54

(95% Cl, 0.43-0.68)
P<0.0001

Median PFS: 8.2 months
(95% CI, 6.1-8.8) with LIBTAYO vs 5.7 months (95% CI,
4.5-6.2) with chemotherapy1,2
  • Number of events: 52% of patients (147 out of 283 patients) with LIBTAYO and 70% of
    patients (197 out of 280 patients) with chemotherapy1,2
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
HR based on stratified proportional hazards model.1

ORR and DOR with LIBTAYO vs platinum-based chemotherapy in EMPOWER-Lung 11,2

Known PD-L1 ≥50% population (n=563)

Objective response rate‡§

  • 37% (95% CI, 32%-42%) (CR=3%, PR=33%) with LIBTAYO vs 21% (95% CI, 17%-25%) (CR=1%, PR=20%) with chemotherapy1

Duration of response§

  • Median of 21 months (range, 1.9+-23.3+ months) with LIBTAYO vs 6 months (range, 1.3+-16.5+ months) with chemotherapy1
Clopper-Pearson exact confidence interval.1
§Not a prespecified endpoint in the 563-patient population with PD-L1 ≥50%.4
+: Ongoing response.2

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.

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. LIBTAYO (cemiplimab-rwlc) injection full U.S. prescribing information. Regeneron Pharmaceuticals, Inc., and sanofi-aventis U.S. LLC. 4. Data on file. Regeneron Pharmaceuticals, Inc.