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A global, randomized, double-blind, placebo-controlled study compared ramucirumab plus BSC and placebo plus BSC in patients with advanced HCC and elevated baseline AFP following first-line sorafenib.1
Patients were stratified by
geographic region (Americas, Europe, Israel, and Australia vs Asia [except Japan] vs Japan)
baseline ECOG PS (0 vs 1), and
macrovascular invasion (yes vs no).1
Patients were randomly assigned (2:1) to receive ramucirumab 8 mg/kg plus BSC (n=197) or placebo plus BSC (n=95) every 14 days until disease progression or unacceptable toxicity, or until discontinuation criteria were met.1
Enrollment Among Patients With Hepatitis as Etiology of Liver Disease
The treatment and management of chronic viral hepatitis was left to the investigator’s discretion or local practice. For patients with chronic HBV or HCV infection, antiviral therapy before and/or throughout the course of treatment could have been considered to reduce the risk of viral reactivation.2 Enrollment among patients with hepatitis as etiology of liver disease in the REACH-2 study is summarized in Table 1.
Table 1. Enrollment Among Patients With Hepatitis2
|
Type of Hepatitisa |
Ramucirumab
+ BSC |
Placebo
+ BSC |
Total |
|
Hepatitis B |
71 (36.0) |
36 (37.9) |
107 (36.6) |
|
Hepatitis C |
48 (24.4) |
28 (29.5) |
76 (26.0) |
|
Hepatitis A |
0 |
1 (1.1) |
1 (0.3) |
|
Hepatitis, Non-A, Non-B, Non-C |
2 (1.0) |
1 (1.1) |
3 (1.0) |
Abbreviation: BSC = best supportive care.
a More than 1 etiology may be reported per patient.
Efficacy
Efficacy according to either hepatitis B or hepatitis C as the etiology of liver disease is summarized in Table 2.
Table 2. Efficacy Results According to Etiology of Liver Disease: Hepatitis B or C2
|
|
RAM
+ BSC |
PBO
+ BSC |
RAM
+ BSC |
PBO
+ BSC |
|
Hepatitis B |
Hepatitis C |
|||
|
Median OSa, mo (95% CI) |
9.17 (5.82-13.50) |
8.51 (5.22-10.68) |
8.28 (6.08-10.97) |
5.98 (3.65-12.94) |
|
HRb (95% CI); p valuec |
0.838 (0.522-1.347); p=NS |
0.762 (0.435-1.334); p=NS |
||
|
Median PFSa, mo (95% CI) |
2.79 (2.33-4.14) |
1.48 (1.41-2.76) |
3.98 (2.83-5.55) |
2.41 (1.41-2.83) |
|
HRb (95% CI); p valuec |
0.433 (0.276-0.679); p=.0002 |
0.333 (0.185-0.601); p=.0002 |
||
Abbreviations: BSC = best supportive care; HR = hazard ratio; NS = not significant; PBO = placebo; PFS = progression-free survival; OS = overall survival; RAM = ramucirumab.
a Estimated using the Kaplan-Meier method.
b Hazard ratio and 95% CI (Wald) were estimated from unstratified Cox model.
c Two-sided p value from unstratified log-rank test.
Safety
No specific safety data according to etiology of liver disease are available. Safety results for the ITT are summarized below.
Treatment-emergent adverse events that occurred in at least 15% of patients in the ramucirumab arm are presented in Table 3.
Table 3. Treatment-Emergent Adverse Events in ≥15% of Patients in the Ramucirumab Arm1
|
TEAE, % of patients |
Any Grade |
Grade ≥3 |
Any Grade |
Grade ≥3 |
|
Ramucirumab
+ BSC |
Placebo
+ BSC |
|||
|
Fatigue |
27.4 |
3.6 |
16.8 |
3.2 |
|
Peripheral edema |
25.4 |
1.5 |
13.7 |
0 |
|
Hypertension |
24.4 |
12.2 |
12.6 |
5.3 |
|
Decreased appetite |
23.4 |
1.5 |
20.0 |
1.1 |
|
Proteinuria |
20.3 |
2.0 |
4.2 |
0 |
|
Abdominal pain |
19.8 |
1.5 |
12.6 |
2.1 |
|
Nausea |
18.8 |
0 |
11.6 |
0 |
|
Ascites |
17.8 |
4.1 |
7.4 |
2.1 |
|
Diarrhea |
16.2 |
0 |
14.7 |
1.1 |
Abbreviations: BSC = best supportive care; TEAE = treatment-emergent adverse events.
1. Zhu AX, Kang YK, Yen CJ, et al. REACH-2: A randomized, double-blind, placebo-controlled phase 3 study of ramucirumab versus placebo as second-line treatment in patients with advanced hepatocellular carcinoma (HCC) and elevated baseline alpha-fetoprotein (AFP) following first-line sorafenib. Presented as an oral presentation at: 54th Annual Meeting of the American Society of Clinical Oncology (ASCO); June 1-5, 2018; Chicago, IL. Abstract #4003. https://meetinglibrary.asco.org/record/159169/abstract
2. Data on file, Eli Lilly and Company and/or one of its subsidiaries.
Glossary
AFP = alpha-fetoprotein
BSC = best supportive care
ECOG = Eastern Cooperative Oncology Group
HBV = hepatitis B virus
HCC = hepatocellular carcinoma
HCV = hepatitis C virus
ITT = intent-to-treat
PS = performance status
Datum fӧr senaste ӧversyn 2018 M07 01