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ITT patient population (N=710)1
Number of deaths: 30% of patients (108 out of 356 patients) with LIBTAYO and 40% of patients (141 out of 354 patients) with chemotherapy1
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)
Known PD-L1 ≥50% patient population (n=563)2,3
Number of deaths: 25% of patients (70 out of 283 patients) with LIBTAYO and 38% of patients (105 out of 280 patients) with chemotherapy2,3
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)
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. PD-L1 IHC 22C3 pharmDx [instructions for use]. Carpinteria, CA: Dako, Agilent Pathology Solutions; 2021. 4. Data on file. Regeneron Pharmaceuticals, Inc.