Translating the Multiple Myeloma MRD Endpoint Precedent into Other Indications to Accelerate Clinical Trial Timelines: A Regulatory Perspective
11:30 am - Friday 19th March 2027
- Unpacking how MRD came to be accepted as an early endpoint in myeloma and which parts of that evidence package transfer to solid tumours, so programs build on precedent rather than starting from zero
- Positioning MRD against pathological complete response in the neoadjuvant setting, where emerging breast and lung data show ctDNA reconciling the patients pCR calls wrong, to either replace or supplement the current readout
- Assessing composite endpoints, radiographic progression or ctDNA detection whichever comes first, as a route to de-risk a readout in indications where good standard of care pushes overall survival out to a decade
