Lenvima plus Keytruda disappoints in unresectable hepatocellular cancer

The final analysis of the Phase III LEAP-002 trial investigating Lenvima (lenvatinib), discovered by Japan’s Eisai (TYO: 4523), plus US pharma giant Merck & Co’s (NYSE: MRK) mega blockbuster Keytruda (pembrolizumab) versus Lenvima monotherapy, was inconclusive for the combination as first-line treatment for patients with unresectable hepatocellular carcinoma (uHCC).

The results were presented at the European Society for Medical Oncology (ESMO) Congress 2022.

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 Lenvima plus Keytruda 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).