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Kudo M
et al
.
Lancet
. 2018;pii:S0140-6736(18)30207–1.
REFLECT TRIAL: Conclusions
§
The REFLECT trial is the
1
st
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.
DCR: disease control rate; uHCC: unresectable hepatocellular carcinoma; IIR: independent imaging review; ORR: objective response ratio; OS: overall survival; PFS:
progression-free survival; TEAE: Treatment Emergent Adverse Events; TTP: time to progression.