- The LEAP-012 trial evaluated KEYTRUDA and LENVIMA with TACE for unresectable, non-metastatic hepatocellular carcinoma.
- The trial did not achieve statistical significance for overall survival, leading to its closure.
- Progression-free survival showed significant improvement compared to TACE alone.
- Further analysis of the trial data is ongoing.
Trial Overview
The Phase 3 LEAP-012 trial assessed the combination of KEYTRUDA, LENVIMA, and transarterial chemoembolization (TACE) for treating unresectable, non-metastatic hepatocellular carcinoma (HCC). The trial aimed to evaluate the efficacy of this combination therapy compared to TACE alone.
Results and Decision
During a pre-specified interim analysis, the combination did not achieve statistical significance for overall survival, one of the primary endpoints. Consequently, the likelihood of reaching the required threshold for statistical significance in future analyses was deemed low, leading to the decision to close the study.
Progression-Free Survival
Despite the lack of overall survival benefit, the trial met its other primary endpoint of progression-free survival, showing a statistically significant and clinically meaningful improvement compared to TACE alone. These findings were presented at the European Society for Medical Oncology Congress 2024 and published in The Lancet.
Ongoing Analysis
Further analysis of the trial data is ongoing, and Merck and Eisai plan to collaborate with investigators to share the results with the scientific community. The safety profile of the combination therapy was consistent with previous studies.
