About the LEAP-002 Trial of Lenvatinib With/Without Pembrolizumab in uHCC

Pierre Gholam, MD, discusses the phase 3 LEAP-002 study of lenvatinib and pembrolizumab for unresectable hepatocellular carcinoma.

Pierre Gholam, MD, professor at Case Western Reserve University School of Medicine in Cleveland, Ohio, discusses the phase 3 LEAP-002 study (NCT03713593) of lenvatinib (Lenvima) and pembrolizumab (Keytruda).

In summary, the LEAP-002 trial was negative and did not show any difference between lenvatinib/pembrolizumab compared with lenvatinib alone for the first-line treatment for patients with unresectable hepatocellular carcinoma.

TRANSCRIPTION:

0:08 | The anticipated data from the LEAP-002 trial, which was a trial of a combination of pembrolizumab and lenvatinib compared with lenvatinib alone in the setting of unresectable HCC in the first-line. There had previously been an announcement that the study did not meet its overall survival end point, but the additional details presented provide some more clarity regarding this.

0:45 | In particular, what they show is that the combination of pembrolizumab and lenvatinib offered a 22.1-month median overall survival vs 19 months for lenvatinib alone. These results are notable, for both the treatment arm and the comparator arm, for the robustness of overall survival. In both cases, some of the best or better results from any first line study.

1:22 | There were some other analyses which were reported including duration of response which was 16.6 months from the combination and 10.4 month for lenvatinib alone. Objective response rate was 26% for the combo and 17% for lenvatinib alone. The safety profile was also coupled with an adverse event background profile, which more or less reflected the expected adverse events associated with both immune checkpoint inhibitor therapy and the TKI [tyrosine kinase inhibitors].

2:02 | That is a very interesting twist on the landscape of HCC in the first-line because it reports on 2 therapies previously studied individually and now in combination which yield median overall survivals that were quite high in the setting of first-line.