Replies to post #142503 on Biotech Values

[iwfal]

CLDX -

Should they choose a two-arm phase III study, investigator's choice could certainly be an option in a less heavily treated population, and they might want to wait for matured PFS data to help size the study.

Based on the KM curves the PFS curves are already very mature. Very little censoring. The only remaining maturity would be if they are still cleaning the database or (re)evaluating the scans.

Should they choose a single-arm study with biomarker enrichment, then they would have to choose the subset and negotiate with FDA on an approvable clinically meaningful response rate (confirmed) in the late line setting in which their responders came from. And you are right they probably wouldn't have any trouble with recruitment although it might take longer to enroll due to a more narrow biomarker selected patient pool.

What is the lowest threshold the FDA has ever used for ORR in refractory patients? 10% confirmed? Not clear from the data that they could pass that hurdle - especially in a more refractory population.