Biotech Values

[jq1234]

there are zero prior data for efficacy at the 120 dose for HCC

Not entirely accurate. In most oncology trials, there are always experience with dose reduction depending on drug tolerability, thus some sort of data on lower dose exist. In ph2 HCC trial, 30% patients in 240mg bid arm got dose reduction, presumably to 120mg bid. In the case of EXEL's cabo when they first tried to test lower dose, they picked 60mg as starting test dose mainly because 60mg was the dose reduction they used extensively in RDT trial. So they were pretty close in their assessment. However, tivan HCC ph2 trial was small and dose reduction in 240mg bid arm wasn't extremely high, thus no where near as much data as cabo RDT where trial was much larger with higher percentage of dose reduction.