Phase III Libtayo trial stopped early on success in first-line NSCLC

The primary endpoint of overall survival (OS) was met in a Phase III trial comparing the PD-1 inhibitor Libtayo (cemiplimab) to platinum doublet chemotherapy in patients with first-line locally advanced or metastatic non-small cell lung cancer (NSCLC) that tested positive for PD-L1 in ≥50% of tumor cells.

Based on a recommendation by the independent Data Monitoring Committee to stop the trial early, the trial will be modified to allow all patients to receive Libtayo for this investigational use, say the drug’s developers, French pharma major Sanofi (Euronext: SAN) and US partner Regeneron Pharmaceuticals (Nasdaq: REGN).

News of the development saw Sanofi’s shares move up 3.3% to 93.97 euros by the end of trading today, while Regeneron was down 4.2% at $542.52 mid-morning, but that was more likely due to the release by the companies of disappointing data related to their joint development of Kevzara (sarilumab) as a potential COVID-19 treatment.