In patients who had no EGFR, ALK, or ROS1 aberrations:

EMPOWER-Lung 1 was designed to enroll advanced NSCLC patients with PD-L1 ≥50%1

Phase 3, large, randomized, multicenter, open-label, active-controlled trial Phase 3, large, randomized, multicenter, open-label, active-controlled trial

The EMPOWER-Lung 1 study was designed to enroll patients with PD-L1 ≥50%.2

  • 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 retesting2
  • 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 expression2 (LIBTAYO is not indicated in patients with <50% PD-L1 expression)

Primary endpoints1:

  • OS and PFS

Secondary endpoints included1,2:

  • ORR (key), DOR, and safety and tolerability

LIBTAYO was examined in a clinical study that included historically underrepresented patients with advanced NSCLC1,2:

In the LIBTAYO arm (ITT patient population) at baseline, 12% of patients had pretreated and stable brain metastases,* 18% had locally advanced disease, and 2% had controlled hepatitis B or hepatitis C. Patients with HIV were permitted to enroll, but none were recruited.1-3
  • *Patients were eligible if they had been adequately treated and had neurologically returned to baseline for at least 2 weeks prior to randomization.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
  • Patients who experienced IRC-assessed RECIST 1.1-defined progressive disease on therapy with LIBTAYO were permitted to continue treatment with LIBTAYO 350 mg Q3W for up to 108 additional weeks, along with the addition of histology-specific chemotherapy for 4 cycles until further disease progression was observed.1
  • §Patients who experienced IRC-assessed RECIST 1.1-defined progressive disease on chemotherapy were permitted to receive treatment with LIBTAYO for up to 108 weeks.1,2
  • Randomization was stratified by histology (nonsquamous vs squamous) and geographic region (Europe vs Asia vs rest of world).1
  • Median duration of exposure was 27.3 weeks (range, 9 days-115 weeks) for LIBTAYO vs 17.7 weeks (range, 18 days-86.7 weeks) for chemotherapy.1
  • DOR=duration of response; ECOG=Eastern Cooperative Oncology Group; IDMC=independent data monitoring committee; IRC=independent review committee;
    IV=intravenous; ORR=objective response rate; PD=progressive disease; PFS=progression-free survival; PS=performance status; Q3W=every 3 weeks; R=randomization; RECIST=Response Evaluation Criteria in Solid Tumors.
Per IDMC recommendation:
Trial stopped early
due to superior OS.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):592-604. Supplementary material available at: https://www.sciencedirect.com/science/article/abs/pii/S0140673621002282. Accessed February 13, 2021. 3. Data on file. Regeneron Pharmaceuticals, Inc.