As of 12 February, the likelihood of approval (LoA) by the FDA of Sanofi/Regeneron Pharmaceuticals’ PD-1 inhibitor Libtayo (cemiplimab) rose by 20 points. The score change followed the publication of the Phase III results indicating Libtayo extended overall survival (OS) in non-small cell lung cancer (NSCLC) patients with a tumor PD-L1 expression of at least 50%. The results were published in The Lancet and had been previously presented at the 2020 European Society for Medical Oncology (ESMO) Virtual Congress.

Libtayo is currently under a Priority Review by the FDA with an approval decision date in this indication of 28 February, while a decision by the European Commission is expected by mid-2021, as per Regeneron. The Phase III study compared Libtayo to chemotherapy in NSCLC patients. While the mOS with chemotherapy was 14.2 months, that with Libtayo was not yet reached (hazard ratio (HR)=0.57; p=0.0002) (Sezer et al; The Lancet; volume 397, issue 10274, P592-604; 13 February 2021). Among the patients with PD-L1 expression of 50% or higher the risk of death was reduced by 43% with Libtayo.

The LoA score, calculated by GlobalData’s analysis that uses a combination of machine learning and a proprietary algorithm, was previously 46%, and increased to 66% following the Phase III publication.  Libtayo is currently approved to treat metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation. This investigative news team had previously reported on 31 January 2019 on Libtayo’s efficacy being extended beyond CSCC to other indications like basal cell carcinoma (BCC), albeit with some extrapolation limitations. Total sales estimated for Libtayo, to both Sanofi and Regeneron amount to USD 2,474m as per GlobalData Consensus Forecast.

Manasi Vaidya is a Senior Reporter for Clinical Trials Arena parent company GlobalData’s investigative journalism team. A version of this article originally appeared on the Insights module of GlobalData’s Pharmaceutical Intelligence Center. To access more articles like this, visit GlobalData.