Altai Protocol Library

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Kütüphanede Ara Ara

New Reference: Cemiplimab for first-line treatment of advanced non-small-cell lung cancer (PD-L1 >=50%)

New Reference: Cemiplimab for first-line treatment of advanced non-small-cell lung cancer (PD-L1 >=50%)
Study:
  • Phase III, open-label (EMPOWER-Lung 1)
  • Advanced NSCLC with PD-L1 >=50%. Never-smokers excluded
  • Cemiplimab 350 q21 (n=283) vs. platinum doublet (n=280). Crossover from chemo to cemiplimab allowed
Efficacy:
  • ORR: 39% vs. 20% (OR: 2.53 [1.74-3.69])
  • Median PFS: 8.2 mos [6.1-8.8 mos] vs. 5.7 mos [4.5-6.2 mos] (HR: 0.54 [0.43-0.68])
  • Median OS: NR [17.9 mos – NE] vs. 14.2 mos [11.2-17.5 mos] (HR: 0.57 [0.42-0.77])
  • Among pts with PD-L1 >=90%: Median PFS: 15.3 mos (n=98) vs. 5.9 mos (n=94)
Safety:
  • Grade >=3 AEs: Thrombocytopenia (0% vs. 8%), neutropenia (1% vs. 10%), immune-mediated hepatitis (1% vs. 0%)

Lancet 2021;397:592.

Sezer A, 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

https://doi.org/10.1016/S0140-6736(21)00228-2

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