Biotech Values

[p3analyze]

>> the progression in the placebo arm was largely driven by new mets<<

This phenomenon has not been reported for docetaxel monotherapy. Would be useful to know the location of new mets. It's possible the short median PFS in LDH high and K-ras muatation subgroup was driven by a higher proportion of clinical progressions due to symptoms associated with new pleural effusion (PE), or new mets in bone or brain. These so-called "new lesion PD" are not as reliable as PD based on measurable target lesions. For an open-label study imbalance in terms of source of PD (clinical PD vs objective PD) would be alarming. In my experience, new or enlarged PE is not always associated with PD of target lesions and not assessed consistently by investigators, and often it is difficult to tell if a new bone or brain lesion is already present at baseline because baseline bone scan or brain MRI are not always collected.