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Cyramza ® (ramucirumab)
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Combined Analysis of REACH and REACH-2
REACH-2 and REACH were both global, randomized, placebo-controlled phase 3 trials with similar study eligibility, protocol procedures, treatment regimen, and study endpoints. In both studies, patients were randomized to receive either ramucirumab plus BSC or placebo plus BSC.1
Efficacy Results
Overall survival among patients in REACH (baseline AFP ≥400 ng/mL), REACH-2, and in the pooled analysis (REACH [baseline AFP ≥400 ng/mL] + REACH-2) are summarized in Table 1. Additional efficacy results among patients in the pooled analysis are summarized in Table 2.
Table 1. Overall Survival Results1
|
Endpoint |
RAM
+ BSC |
PBO+
BSC |
RAM
+ BSC |
PBO
+ BSC |
RAM
+ BSC |
PBO
+ BSC |
||
|
REACH (Baseline AFP ≥400 ng/mL)a |
REACH-2a |
Pooled (REACH [Baseline AFP ≥400 ng/mL] + REACH-2) |
||||||
|
Median OS, months |
7.8 |
4.2 |
8.5 |
7.3 |
8.1 |
5.0 |
||
|
HR (95% CI); p value |
0.674 (0.508-0.895); p=.0059 |
0.710 (0.531-0.949); p=.0199 |
0.694 (0.571-0.842); p=.0002 |
|||||
Abbreviations: AFP = alpha fetoprotein; BSC = best supportive care; HR = hazard ratio; OS = overall survival; PBO = placebo; RAM = ramucirumab.
a Impact of post-discontinuation therapy was minimal; censoring at time of initiation of postdiscontinuation therapy demonstrated impact on median OS was <1 month in either arm.
Table 2. Efficacy Results Among Patients in the Pooled Analysis (REACH [Baseline AFP ≥400 ng/mL] + REACH-2)1
|
Efficacy Endpoints |
RAM
+ BSC |
PBO
+ BSC |
|
Median PFS, months |
2.8 |
1.5 |
|
HR (95% CI); p value |
0.572 (0.472-0.694); p<.0001 |
|
|
ORRa (95% CI), % |
5.4 (2.9-7.9) |
0.9 (0-2.1) |
|
P value |
p=.0064 |
|
|
DCRa (95% CI), % |
56.3 (50.9-61.8) |
37.2 (30.9-43.5) |
|
P value |
p<.0001 |
|
Abbreviations: AFP = alpha fetoprotein; BSC = best supportive care; DCR = disease control rate; HR = hazard ratio; ORR = objective response rate; PBO = placebo; PFS = progression-free survival; RAM = ramucirumab; RECIST = Response Evaluation Criteria in Solid Tumors; v = version.
a Tumor assessment based on RECIST, v1.1.
Safety Results
Adverse events of special interest from the pooled analysis (REACH [baseline AFP ≥400 ng/mL] + REACH-2) analysis are presented in Table 3.
Table 3. Adverse Events of Special Interest Among Patients in the Pooled Analysis (REACH [Baseline AFP ≥400 ng/mL] + REACH-2)1
|
AESI, % of patients |
Any Grade |
Grade ≥3 |
Any Grade |
Grade ≥3 |
|
RAM
+ BSC |
PBO
+ BSC |
|||
|
Liver injury/liver failure |
44.3 |
19.9 |
39.0 |
26.5 |
|
Ascitesa |
20.9 |
4.7 |
14.8 |
4.0 |
|
Hepatic encephalopathya |
4.1 |
2.8 |
0.9 |
0.4 |
|
Bleeding/hemorrhage events |
25.0 |
4.7 |
17.9 |
6.7 |
|
GI hemorrhage events |
7.6 |
3.5 |
8.5 |
5.4 |
|
Epistaxisa |
12.3 |
0.3 |
5.4 |
0 |
|
Hypertension |
21.5 |
12.7 |
9.0 |
3.6 |
|
Proteinuria |
18.7 |
1.3 |
5.4 |
0 |
|
Infusion-related reactionsb |
9.2 |
0.3 |
3.1 |
0 |
|
Arterial TE |
1.6 |
0.9 |
1.3 |
0.9 |
|
Venous TE |
0.9 |
0.3 |
2.7 |
2.2 |
|
GI perforation |
0.6 |
0.6 |
0.9 |
0.9 |
|
Congestive heart failure |
0.3 |
0.3 |
0.4 |
0.4 |
|
Fistula |
0.3 |
0 |
0 |
0 |
Abbreviations: AESI = adverse event of special interest; AFP = alpha fetoprotein; BSC = best supportive care; GI = gastrointestinal; PBO = placebo; RAM = ramucirumab; TE = thromboembolic.
a Preferred term.
b Occurred within 24 hours of infusion.
1. Zhu AX, Finn RS, Galle PR, et al. Ramucirumab as second-line treatment in patients with advanced hepatocellular carcinoma (HCC) and elevated alpha-fetoprotein (AFP) following first-line sorafenib: pooled efficacy and safety across two global randomized phase 3 studies (REACH-2 and REACH). Talk presented at: 20th Annual Meeting of the European Society for Medical Oncology (ESMO) World Congress on Gastrointestinal Cancer; June 20-23, 2018; Barcelona, Spain. Abstract #LBA-001. https://www.postersessiononline.eu/173580348_eu/congresos/20wcgic/aula/-LB_1_20wcgic.pdf
Glossary
AFP = alpha-fetoprotein
BSC = best supportive care
HCC = hepatocellular carcinoma
Datum fӧr senaste ӧversyn 2019 M01 22