The P-III (LEAP-002) trial evaluating Keytruda + Lenvima vs Lenvima monothx. in a ratio (1:1) in 794 patients with uHCC
The trial failed to meet its dual 1EPs of OS & PFS in patients with uHCC, trends toward improvement in OS & PFS but these results did not meet statistical significance per the pre-specified statistical plan, m-OS of the Lenvima monothx. was longer than that observed in prior reported clinical trials. The safety profile of Keytruda + Lenvima was consistent with prior reported data on the combination
The results are expected to be presented at an upcoming medical conference. Keytruda is currently approved as monothx. in the US, EU, China, Japan & other countries globally for the same indication
Ref: Businesswire | Image: Merck
