Results From phase III LEAP-002 trial evaluating Keytruda + Lenvima versus Lenvima monotherapy in patients with unresectable hepatocellular carcinoma (liver cancer)- Merck Inc.,+ Eisai

Results are being presented during a proffered paper session at the European Society for Medical Oncology (ESMO) Congress 2022, being held in Paris, France and virtually from Sept. 9-13 (abstract #LBA34).

In the final analysis of the trial, there was a trend toward improvement for one of the study’s dual primary endpoints, overall survival (OS), for patients treated with Keytruda plus Lenvima versus Lenvima monotherapy; however, the results did not meet statistical significance per the pre-specified statistical plan (HR=0.84 [95% CI: 0.71-1.00]; p=0.0227). The median OS was 21.2 months (95% CI: 19.0-23.6) for Keytruda plus Lenvima and 19.0 months (95% CI: 17.2-21.7) for Lenvima monotherapy. Additionally, treatment with Keytruda plus Lenvima resulted in a trend toward improvement in the trial’s other dual primary endpoint of progression-free survival (PFS) versus Lenvima monotherapy; however, the results did not meet the pre-specified threshold at the first interim analysis for statistical significance (HR=0.87 [95% CI: 0.73-1.02]; p=0.0466).

“While the outcome is not what we had hoped, it is important for us to see that patients in the trial treated with Lenvima monotherapy had a median overall survival of 19.0 months,” said Corina Dutcus, M.D., Senior Vice President, Clinical Research, Oncology at Eisai Inc. “Findings from the LEAP-002 trial will not only help advance our understanding and application of Keytruda plus Lenvima across our clinical development program but will also provide physicians with additional information on Lenvima monotherapy’s use in unresectable hepatocellular carcinoma, where it is currently approved as a treatment option in multiple regions around the world, including the U.S., the European Union (EU), Japan and China.”