A Controlled Trial of Nintedanib in IPF (TOMORROW)

TOMORROW was the phase 2 dose-finding trial for nintedanib in IPF that led to the INPULSIS phase 3 trials.

Phase 2 RCT (n=432) testing four doses of nintedanib vs. placebo in IPF over 52 weeks.

Nintedanib 150 mg twice daily reduced FVC decline (−0.06 L vs −0.19 L, p=0.06) and acute exacerbations (2.4% vs 15.7%). Diarrhea was the main side effect (36%).

TOMORROW established the 150 mg BID dose and provided the rationale for INPULSIS. Diarrhea management is key to nintedanib tolerability — dose reduction to 100 mg BID is an option.

Phase 2 — underpowered for definitive conclusions. Led to the definitive INPULSIS trials.