Question · Q3 2025
Manoj Eradath asked if the recent Harmony III trial changes, which involve separate statistical analysis for squamous and non-squamous NSCLC populations, would impact the powering of the ROSETTA 02 trial (BNT327 plus chemotherapy) for PFS and OS endpoints in its Phase III portion, and if any trial design changes are anticipated.
Answer
Özlem Türeci, Chief Medical Officer and Co-founder, responded that BioNTech constantly re-evaluates its statistical analysis plans for ongoing trials based on new data and will specifically look into the implications for the ROSETTA 02 trial.