ELAD system: Phase III data
Top-line data from the open-label, international Phase III VTI-208 trial in 203 patients with AILD showed that the ELAD system given up to 5 times in combination with standard of care (SOC) missed the primary endpoint of improving OS through at least 91 days vs. SOC alone (HR=1.027, p=0.9). ELAD plus SOC also missed the secondary endpoints of a greater proportion of survivors at days 28 and 91 vs. SOC alone (p=0.45 and p=0.74, respectively). There were 156 treatment-emergent serious adverse events reported in the ELAD system arm vs. 168 in the SOC arm.
In a pre-specified exploratory subset of patients from the intent-to-treat (ITT) population with a Model for End-Stage Liver Disease (MELD) score of <28 points at baseline (n=120), the OS hazard ratio was 0.575 for the ELAD system plus SOC vs. SOC alone (p=0.077). In the 120-patient subset, the ELAD system plus SOC led to an 80.4% OS rate at day 91 vs. 65.2% for SOC alone (p=0.068). In a subset of patients from the per protocol (PP) population with an MELD score of <28 points at baseline(n=116), the OS p-value was 0.059 for ELAD plus SOC vs. SOC alone. Vital said that outcomes appeared to be worse in the ELAD arm compared to the SOC arm in patients with MELD scores of >28 points at randomization. ...