Lenvatinib en carcinoma hepatocelular avanzado o irresecable

Dr. Teresa MacarullaHospital Vall d´Hebrón

Datos de vida real de Lenvatinib en el Japón

Tsuchiya K et al, presented in 2019 ASCO GI meeting

Datos de vida real de Lenvatinib en el Japón

Tsuchiya K et al, presented in 2019 ASCO GI meeting

Datos de vida real de Lenvatinib en el Japón

Tsuchiya K et al, presented in 2019 ASCO GI meeting

REFLECT trial: CONCLUSIONES

▪ The REFLECT trial is the 1st successful phase 3 trial in the first line setting in uHCC in approximately 10 years.

▪ Lenvatinib met its primary endpoint of OS by statistical confirmation of non-inferiority to Sorafenib (13.6 months vs 12.3 months; HR 0.92; CI 0.79-1.06).

▪ Lenvatinib has achieved statistically significant and clinically meaningful improvement versus sorafenib, assessed by mRECIST, in:

▪ PFS (7.4 months vs 3.7 months; HR 0.66; p<0.0001)▪ TTP (8.9 vs 3.7 months; HR=0.63; p<0.0001)▪ ORR (24% vs 9%, OR=3.13; p<0.0001)

▪ Secondary endpoints of PFS, TTP, and ORR were confirmed by masked IIR.

▪ No new safety signals were found in the lenvatinib arm, and toxicities were managed with dose interruption, modification or discontinuation.

▪ Lenvatinib ESMO- MCBS score is 4.