The Lancet publishes pivotal Libtayo data showing extended overall survival in patients with first-line advanced NSCLC with PD-L1 expression of greater than 50%.- Sanofi + Regeneron.

The Lancet has 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 greater than 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. “These clinical results published in The Lancet support regulatory submissions for Libtayo as a potential new treatment option for patients with advanced NSCLC with PD-L1 expression of greater than 50%,” said Ahmet Sezer, M.D., Professor in the Department of Medical Oncology at Ba?kent University in Adana, Turkey and a trial investigator. “Libtayo was superior in extending overall survival compared to chemotherapy, even with 74% of patients crossing over to the Libtayo arm following progression on chemotherapy. Libtayo reduced the risk of death by 32% in all patients in the pivotal trial and by 43% among those with confirmed PD-L1 expression of 50% or higher. In addition, the data included more advanced patient populations usually underrepresented in advanced NSCLC trials – including 12% with pretreated and stable brain metastases and 16% with locally advanced NSCLC who were not candidates for definitive chemoradiation. As a result, the medical community now has valuable new clinical evidence that could enhance our understanding of how to treat this deadly cancer.” The safety of Libtayo in the trial was generally consistent with previous Libtayo pivotal trials, and according to the publication, consistent with the safety profiles of other PD-1 or PD-L1 inhibitors in NSCLC and other tumor types. Grade 3 or 4 adverse events occurred in 28% and 39% of patients in the Libtayo and chemotherapy arms, respectively. Immune-mediated AEs were reported in 17% of patients in the Libtayo arm, compared to 2% in the chemotherapy arm, and included hypothyroidism (6% versus 0%), hyperthyroidism (4% versus <1%), pneumonitis (2% versus 0%), hepatitis (2% versus 0%), skin adverse reaction (2% versus><1%), colitis (1% versus><1%), nephritis (><1% versus><1%), arthritis, increased blood thyroid stimulating hormone, thyroiditis, and peripheral neuropathy (all><1% versus 0%). libtayo is currently approved as the first systemic treatment in the u.s., eu and other countries for adults with metastatic cutaneous squamous cell carcinoma (cscc) or locally advanced cscc who are not candidates for curative surgery or curative radiation. libtayo is also approved in the u.s. as the first immunotherapy treatment indicated for patients with advanced basal cell carcinoma (bcc) previously treated with a hedgehog pathway inhibitor (hhi) or for whom an hhi is not appropriate, and is under regulatory review in the eu for the treatment of locally advanced bcc previously treated with an hhi.libtayo is being jointly developed and commercialized by sanofi and regeneron under a global collaboration agreement. the use of libtayo to treat advanced nsclc is investigational and has not been fully evaluated by any regulatory authority. see- "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"-ahmet sezer, md, prof saadettin kilickap, md, prof mahmut gümü?, md, prof igor bondarenko, md. et al. published:february 13, 2021doi:https: doi.org 10.1016 s0140-6736(21)00228-2..>