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Cyramza ® (ramucirumab)
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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 According to Gender
In the REACH-2 study, 233 patients (79.8%) were male and 59 patients (20.2%) were female.
Among patients who received ramucirumab plus BSC
154 patients (78.2%) were male, and
43 patients (21.8%) were female.
Among patients who received placebo plus BSC
79 patients (83.2%) were male, and
16 patients (16.8%) were female.1
Efficacy
No significant differences in efficacy were observed between male and female participants.2 Efficacy results according to gender are summarized in Table 1.
Table 1. Efficacy Results According to Gender2
|
|
RAM
+ BSC |
PBO
+ BSC |
RAM
+ BSC |
PBO
+ BSC |
|
Male |
Female |
|||
|
Median OSa, mo (95% CI) |
8.08 (6.74-10.58) |
6.60 (5.22-8.97) |
8.80 (5.82-13.37) |
9.07 (5.88-17.94) |
|
HRb (95% CI); p valuec |
0.696 (0.509-0.952); p=.0234 |
1.206 (0.591-2.459); p=NS |
||
|
Interaction p valued |
p=NS |
|||
|
Median PFSa, mo (95% CI) |
2.83 (2.73-4.14) |
1.54 (1.45-2.56) |
2.92 (2.63-4.17) |
2.73 (1.41-2.79) |
|
HRb (95% CI); p valuec |
0.457 (0.338-0.619); p<.0001 |
0.532 (0.278-1.020); p=.0520 |
||
|
Interaction p valued |
p=NS |
|||
|
ORR, n (%) |
6 (3.9) |
1 (1.3) |
3 (7) |
0 |
|
DCR, n (%) |
90 (58.4) |
29 (36.7) |
28 (65.1) |
8 (50.0) |
Abbreviations: BSC = best supportive care; DCR = disease control rate; HR = hazard ratio; NS = not significant; ORR = overall response rate; OS = overall survival; PBO = placebo; PFS = progression-free 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.
d Wald test of treatment-by-subgroup interaction from unstratified Cox model.
Safety
No clinically relevant differences were seen in terms of TEAE profile or differences between treatment arms in males and females. Any grade TEAEs that occurred in at least 20% of patients in the ramucirumab arm (summarized by gender) are summarized in Table 2.
Table 2. Any Grade TEAEs in ≥20% of Patients who Received Ramucirumab Plus BSC2
|
MedDRA Preferred Term |
RAM
+ BSC |
PBO
+ BSC |
RAM
+ BSC |
PBO
+ BSC |
|
Male |
Female |
|||
|
Fatigue |
29.9 |
17.7 |
18.6 |
12.5 |
|
Hypertension |
24.7 |
13.9 |
23.3 |
6.3 |
|
Decreased appetite |
24.0 |
22.8 |
20.9 |
6.3 |
|
Peripheral edema |
24.0 |
16.5 |
30.2 |
0 |
|
Nausea |
20.8 |
10.1 |
11.6 |
18.8 |
|
Abdominal pain |
20.1 |
11.4 |
18.6 |
18.8 |
|
Proteinuria |
19.5 |
3.8 |
23.3 |
6.3 |
|
Ascites |
14.9 |
7.6 |
27.9 |
6.3 |
|
Urinary tract infection |
1.3 |
1.3 |
20.9 |
0 |
Abbreviations: BSC = best supportive care; MedDRA = Medical Dictionary of Regulatory Activities; PBO = placebo; RAM = ramucirumab; TEAE = treatment-emergent adverse event.
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
CI = confidence interval
DCR = disease control rate
ECOG = Eastern Cooperative Oncology Group
HCC = hepatocellular carcinoma
HR = hazard ratio
MedDRA = Medical Dictionary for Regulatory Activities
OS = overall survival
PBO = placebo
PFS = progression-free survival
PS = performance status
TEAE = treatment-emergent adverse event
Datum fӧr senaste ӧversyn 2018 M07 01