RedEye implies?
I think the situations of Faron and Replimune are quite essentially different.
- Replimune’s problem was that it was impossible to distinguish the effect of the investigational drug from nivolumab. Faron has the same question in its current data, but the difference is that azacitidine responses and historical levels are well known, biomarkers support the mechanism of action… and above all, the next phase will be randomized precisely to address this question in line with the FDA.
- Replimune’s data also involved measurement challenges and possible confounding factors with local injections + surgical procedures, whereas Faron’s hematological endpoints (CR, ORR, OS) are more clearly interpretable.
- The indications are different: PD-1-resistant melanoma is a highly competitive and difficult field, whereas in HR-MDS, the unmet need is high, which allows for more flexibility regarding endpoints and the development pathway, although evidence requirements remain.
- The key difference, however, is that Replimune essentially got stuck in a single-arm setup, while Faron has already moved towards a randomized setup in accordance with FDA requirements.