Biotech Values

[dewophile]

It's probably early still to think about changes to the current trial. For MRD specifically TRIL obviously doesn't need a new cohort since they can already enroll these pts as long as they have relapsed or refractory disease. They can certainly share data as it is available w investigators and that alone can help boost enrollment if this is where they think the drug works best. If TRIL down the road wants to offer their drug after say front line chemo for pts in CR but with MRD (i can envision this for say frail pts who cannot tolerate further consolidation and/or transplant) they would then need to get the OK from the FDA. They would need a lot more data before they entertained something like this.
If the drug does work in pts w low disease burden I do think there is a good chance it will find a role somewhere. It might be in the relapsers who are picked up early by molecular methods. It might be to improve outcomes in patients who are not candidates for transplant who get a CR but have MRD. it might even enable some patients to avoid something very toxic like further chemo or transplant altogether - i.e. convert a high risk for relapse pt (which is the majority) to a low risk category who can then avoid a very toxic consolidation tx. I would also be curious to know if TRIL is looking at other markers such as those associated wth CSCs - if the drug can kill these cells it could help improve outcomes even in patients who have a molecular response but have not been screened with some of these newer markers of CSCs. Who knows.

On another note I also think TRIL is going to drop some cohorts soon if the data is not there - money is getting tight