Ascelia Pharma AB (publ) (ticker: ACE), a biotech focused on improving the life of people living with rare cancer conditions, today provided clarifications around intra-reader variability in scoring of images from the pivotal Phase 3 study SPARKLE with the liver imaging candidate drug Orviglance®.
Based on the questions Ascelia Pharma received after the announcement on August 8, 2023, the company would like to provide the following clarification to support the understanding of the issue with intra-reader variability in scoring of images.
- The two readers with high level of intra-reader variability had variability in all image series. The high level of intra-reader variability was also seen in the unenhanced images.
- When measuring effects in clinical trials, it is critical that the method of measurement can be trusted. FDA guidance for ensuring this in imaging studies is to examine how much individual readers vary their evaluation of the same set of images at two different time points. Small differences (low intra-reader variability) are expected and considered acceptable, but when the difference is large (high intra-reader variability), it is considered unacceptable, and hence the data cannot be used to generate a result.
- With a high level of intra-reader variability, we do not know the true values which can be used for analysis of the data.
All efforts and resources in Ascelia Pharma will now be focused on planning and executing a re-evaluation of the images from SPARKLE. This includes a dialogue with the FDA. As a consequence, activities not related to the re-evaluation will be postponed and cost-saving initiatives will be taken. In mid-September, we will communicate a timeline and financial implications for the completion of the re-evaluation.