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LENVIMA® (lenvatinib) capsules 10 mg and 4 mg logo
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1st-Line treatment of uHCC RAI-refractory DTC 1st-Line treatment of aRCC 2nd-Line treatment of aRCC Advanced EC
LENVIMA® for first-line unresectable hepatocellular carcinoma

LENVIMA vs sorafenib in the REFLECT trial

PRIMARY EFFICACY ENDPOINT

13.6-month median OS1

LENVIMA achieved the noninferiority primary endpoint vs sorafenib in the REFLECT trial1

Overall survival LENVIMA

n=478

 sorafenib

n=476
Median OS in months (95% CI) 13.6 (12.1-14.9) 12.3 (10.4-13.9)
Hazard ratio (95% CI)a 0.92 (0.79-1.06)
LENVIMA achieved the non-inferiority primary endpoint versus sorafenib in the REFLECT trial.
  • Number of events: 351 (73%) with LENVIMA vs 350 (74%) with sorafenib1
  • LENVIMA did not demonstrate a statistically significant improvement in OS vs sorafenib1

REFLECT=A Multicenter, Randomized, Open-Label, Phase 3 Trial to Compare the EFficacy and Safety of LEnvatinib (E7080) Versus Sorafenib in First-Line Treatment of Subjects With UnreseCtable HepaTocellular Carcinoma; HCC=hepatocellular carcinoma; OS=overall survival; HR=hazard ratio; CI=confidence interval.

  1. aBased on stratified Cox-model. The noninferiority margin for the HR of LENVIMA vs sorafenib is 1.08.1

SECONDARY EFFICACY ENDPOINT

Double the median PFS: More time without progression1,2

LENVIMA demonstrated statistically superior PFS per independent radiology review (mRECIST)1

LENVIMA achieved double the median PFS: More time without progression. LENVIMA achieved double the median PFS: More time without progression mobile. LENVIMA achieved double the median PFS: More time without progression mobile.

Patients had more time without their disease progressing1

  • Number of events: 311 (65%) with LENVIMA vs 323 (68%) with sorafenib1
  • mRECIST for HCC criteria measure the sum of viable (enhancement in the arterial phase) tumor diameters and may more accurately measure response in HCC liver lesions than RECIST 1.13,4

Independent assessment of PFS using RECIST 1.1 criteria1:

  • Median PFS of 7.3 months with LENVIMA and 3.6 months with sorafenib (HR: 0.65 [95% CI: 0.56-0.77])
  • Number of events: 307 (64%) with LENVIMA vs 320 (67%) with sorafenib

PFS=progression-free survival; mRECIST=modified Response Evaluation Criteria In Solid Tumors; HR=hazard ratio; HCC=hepatocellular carcinoma; RECIST=Response Evaluation Criteria In Solid Tumors; CI=confidence interval.

SECONDARY EFFICACY ENDPOINT

More than triple the ORR: More patients with a response1

LENVIMA demonstrated statistically superior ORR per independent radiology review (mRECIST)1

LENVIMA achieved more than triple the ORR: More patients with a response.

41% of patients with a response to LENVIMA vs 12% with a response to sorafenib1

  • Tumor assessment was based on mRECIST for HCC criteria, which measure the sum of viable (enhancement in the arterial phase) tumor diameters and may more accurately measure response in HCC liver lesions than RECIST 1.13,4

Independent assessment of ORR using RECIST 1.1 criteria1:

  • 19% ORR with LENVIMA (95% CI: 15%-22%) and 7% with sorafenib (95% CI: 4%-9%)1
  • CR: 0.4% (n=2) with LENVIMA vs 0.2% (n=1) with sorafenib
  • PR: 18.4% (n=88) with LENVIMA vs 6.3% (n=30) with sorafenib

ORR=objective response rate; mRECIST=modified Response Evaluation Criteria In Solid Tumors; CR=complete response; PR=partial response; HCC=hepatocellular carcinoma; RECIST=Response Evaluation Criteria In Solid Tumors; CI=confidence interval.

FEATURED VIDEO

REFLECT: A phase 3 clinical trial in patients with uHCC1,5

Dr Kim reviews the safety and efficacy data from REFLECT, a head-to-head clinical trial comparing OS, PFS, and ORR of first-line LENVIMA vs sorafenib. Explore our video library.

REFLECT=A Multicenter, Randomized, Open-Label, Phase 3 Trial to Compare the EFficacy and Safety of LEnvatinib (E7080) Versus Sorafenib in First-Line Treatment of Subjects With UnreseCtable HepaTocellular Carcinoma; uHCC=unresectable hepatocellular carcinoma; OS=overall survival; PFS=progression-free survival; ORR=objective response rate.

Learn about an exploratory subgroup analysis
Study Design Exploratory Subgroup Analysis