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Patients with intermediate-stage liver cancer may benefit from receiving a Lenvima-Keytruda combination with transarterial chemoembolization.
Patients with intermediate-stage hepatocellular carcinoma — a type of liver cancer — had significantly improved progression-free survival (PFS; time patients live without their disease worsening or spreading) after receiving Lenvima (lenvatinib), Keytruda (pembrolizumab) and transarterial chemoembolization (TACE), according to data that were presented at the 2024 ESMO Congress.
Of note, TACE is a procedure for certain types of liver cancer that involves injecting chemotherapy directly into the blood vessels that supply the tumor. Simultaneously, small particles called embolic agents are injected into the vessels to block blood flow to the tumor, which can prevent it from growing.
Study Highlights:
Findings were presented at the meeting based on the phase 3 LEAP-012 study, which included a total of 480 patients with intermediate-stage liver cancer. The total patients were randomly assigned to two groups to receive Lenvima plus Keytruda and TACE (237 patients) or placebo (inactive drug) plus TACE (241 patients).
At a data cutoff date of January 30, 2024, the median PFS was 14.6 months and 10 months in the Lenvima-Keytruda-TACE combination group and placebo plus TACE groups, respectively.
At 12 months, the PFS was 62.2% and 43.4% in the Lenvima-Keytruda-TACE combination group and placebo plus TACE groups, respectively. At 18 months, the PFS was 39.1% and 27.9% in the respective treatment groups.
“Treatment with [Lenvima], [Keytruda] and TACE may be a new option for patients with intermediate-stage hepatocellular carcinoma,” Dr. Josep M. Llovet, director of the Liver Cancer Program and professor of Medicine in the Division of Liver Diseases at the Icahn School of Medicine at Mount Sinai in New York, said during the presentation.
Dual primary endpoints (main results measured at the end of the study) were PFS and overall survival (OS; time patients live regardless of disease status). The secondary endpoints were objective response rate (ORR; percentage of patients whose disease disappeared or shrank), duration of response (DOR; length of response to treatment), disease control rate (DCR), time to progression (TTP; when the disease worsens or spreads) and safety.
At the data cutoff, the OS at 12 months was 89.0% and 83.1% in the combination and placebo plus TACE groups, respectively; after 24 months, the OS was 74.6% and 68.6% in the respective groups.
The ORR was 46.8% and 33.3% in the combination and placebo plus TACE groups, respectively. In the combination group, the complete response, partial response, stable disease and progressive disease were 3.4%, 43.5%, 42.6% and 6.8%, respectively. In the placebo plus TACE group, the complete response, partial response, stable disease and progressive disease were 4.1%, 29.2%, 48.1% and 14.8%, respectively.
The median DOR was 12.6 months and 10.7 months in the combination and placebo plus TACE groups, respectively. The DCR was 89.5% and 81.5%, respectively.
Regarding safety, treatment-related side effects occurred in 234 (98.7%) and 204 (84.6%) patients in the combination and placebo plus TACE groups, respectively; grade 3 or 4 (severe to life-threatening) side effects occurred in 169 (71.3%) and 75 (31.1%) patients.
Serious side effects occurred in 79 (33.3%) and 30 (12.4%) patients, with side effects leading to treatment discontinuation in 20 (8.4%) and three (1.2%) patients. Side effect-related deaths occurred in four (1.7%) and one (0.4%) patient.
The most common treatment-related side effects were hypertension (high blood pressure), proteinuria (increased protein in urine), increased alanine aminotransferase (ALT; enzyme in the liver that may indicate liver damage or inflammation), increased aspartate aminotransferase (AST; another enzyme in the liver that can indicate liver damage or inflammation), decreased platelet count, hypothyroidism, increased blood bilirubin (jaundice), decreased appetite, diarrhea, decreased weight, fatigue, hoarse voice, and post-embolization syndrome.
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