2018 GI CANCERS SYMPOSIUM: First-Line Lenvatinib vs Sorafenib in Unresectable Hepatocellular Carcinoma

The results of an analysis of the phase III REFLECT trial of lenvatinib mesylate (Lenvima) vs sorafenib (Nexavar) as first-line treatment for unresectable hepatocellular carcinoma based on independent imaging review were presented during the 2018 Gastrointestinal (GI) Cancers Symposium (Abstract 345). The presentation reported on an exploratory analysis of the secondary endpoints of progression-free survival, time to progression, and objective response rate in the REFLECT study based on blinded independent imaging review.

The independent imaging review based on both Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, which uses the traditional assessment of the effect on change in tumor diameter, and modified RECIST (mRECIST), which takes into account areas of tumor necrosis in addition to the RECIST 1.1 criteria, confirmed the investigators' findings of extensions in progression-free survival and time to progression as well as an increase in objective response rate compared to sorafenib based on lenvatinib's superior reduction in tumor size. The results of the blinded independent imaging review of the REFLECT study support the imaging findings of the clinical trial investigators.

The five most common adverse events observed in the lenvatinib arm were hypertension, diarrhea, decreased appetite, weight loss, and fatigue, which is consistent with the known safety profile of lenvatinib.

Efficacy outcome

Assessment method

Lenvatinib
(n = 478)

Sorafenib
(n = 476)

Hazard ratio
(95% CI)

P value

Median PFS

Investigator

7.4 mo

3.7 mo

0.66 (0.57–0.77)

< .00001

IIR

7.3 mo

3.6 mo

0.64 (0.55–0.75)

< .00001
(nominal)

7.3 mo

3.6 mo

0.65 (0.56–0.77)

< .00001
(nominal)

Median TTP

Investigator

8.9 mo

3.7 mo

0.63 (0.53–0.73)

< .00001

IIR

7.4 mo

3.7 mo

0.60 (0.51–0.71)

< .00001
(nominal)

7.4 mo

3.7 mo

0.61 (0.51–0.72)

< .00001
(nominal)

Efficacy outcome

Assessment method

Lenvatinib
(n = 478)

Sorafenib
(n = 476)

Odds ratio 
(95% CI)

P value

ORR

Investigator

24.1%

9.2%

3.13 (2.15–4.56)

< .00001

IIR

40.6%

12.4%

5.01 (3.59–7.01)

< .00001
(nominal)

18.8%

6.5%

3.34 (2.17–5.14)

< .00001
(nominal)

CI = confidence interval; PFS = progression-free survival; IIR = independent imaging review;
ORR = overall response rate; TTP = time to progression.

 

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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