COMET-TAIL Phase III trial of Xevudy meets endpoint in COVID-19.

The COMET-TAIL Phase III trial was designed to evaluate the efficacy, safety, and tolerability of sotrovimab delivered via IM administration compared to IV administration in high-risk patients up to seven days after symptom onset. In the IM administration (500mg) arm of the trial, there was a 2.7% rate of progression to hospitalisation for more than 24 hours or death through Day 29 of the trial, compared to 1.3% in the IV administration arm (also 500mg). The adjusted difference between the IM and IV arms of the trial was 1.07% with a 95% confidence interval (CI) of -1.25% to 3.39%. The upper bound of the 95% CI is within the predetermined 3.5% non-inferiority margin set for the trial’s primary endpoint in consultation with the US Food and Drug Administration (FDA).

In addition, there were low rates of serious adverse events and Grade 3-4 adverse events (up to 1% in both arms, for both measures) observed in the headline data. The companies plan to progress regulatory submissions globally, including ongoing discussions with the FDA regarding the existing Emergency Use Authorization for sotrovimab.