IPSEN, OOO

Germany's role in clinical trials is declining due to bureaucratic hurdles and data protection challenges, despite EU Regulation 536/2014's efforts to streamline processes. The new CTIS system faces criticism for inefficiency. Federal Health Minister Karl Lauterbach plans legislative changes to enhance Germany's research appeal. Standardized study contracts, like the BZKF's oncology model, aim to expedite trial processes.

LEAP-012 trial showed len + pembro + TACE significantly improved PFS vs placebo + TACE in intermediate-stage HCC patients. OS data were immature, with a trend toward improvement. Safety profiles were consistent with known effects of the treatments. OS will be reassessed in future analyses.