OBR Daily Commentary


The Lancet Publishes Libtayo® (cemiplimab) Data Showing Extended Overall Survival in Patients With First-line Advanced Non-Small Cell Lung Cancer With PD-L1 Expression of ³50%

(Sanofi) Feb 12, 2021 - The Lancet today published results from a pivotal trial designed to evaluate the investigational use of the PD-1 inhibitor Libtayo® (cemiplimab) compared to platinum-doublet chemotherapy in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with ≥50% PD-L1 expression in tumor cells. The data were shared during a late-breaking presentation at the 2020 European Society for Medical Oncology (ESMO) Virtual Congress and formed the basis of regulatory submissions in the U.S. and European Union (EU). The U.S. Food and Drug Administration (FDA) granted a Priority Review with a target action date of February 28, 2021. A European Commission decision is expected by mid-2021.

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H. Jack West, MD (Posted: February 12, 2021)


As the third entrant in the same clinical setting to show a survival benefit over a quite outdated comparator arm of chemotherapy alone, cemiplimab fails to demonstrate any meaningful incremental benefit over pembrolizumab as the current standard of care in this setting or atezolizumab as a similarly active but already arguably redundant alternative here. I strongly suspect that clinicians will not see a compelling reason to change their current preference in this setting, absent a marked cost difference in favor of cemiplimab to offer a point of differentiation.



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