Run a Phase III trial of TIVO- Afinitor vs. Sorafenib- Afinitor.
TIVO-Afinitor-Dov vs. Sorafenib- Afinitor- Sutent/BEV
to get a piece of 1st-line
to cement TKI-mTOR as the standard of care
TIVO should be a cheap get from AVEO -- they just got rejected by the ODAC/FDA and Astellas pulled out as a partner for RCC. But TIVO significantly improved PFS. The OS trend that got them rejected was almost surely due to one-way crossover. Designing a winning trial for this known quantity would not be as risky as moving a newer agent to 1st-line in Phase III.