Cyramza® (Ramucirumab)

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Ramucirumab: The REACH-2 Study

Ramucirumab as a single agent is indicated for the treatment of patients with HCC who have an AFP of ≥400 ng/mL, after prior sorafenib therapy.

MX_cFAQ_RAM087_REACH2_HCC
MX_cFAQ_RAM087_REACH2_HCC
es-MX

The information contained in this letter may not completely match the current local labeling for RAMUCIRUMAB. Please see local labeling approved in your country. 

Study Design

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

The primary endpoint was OS.1

Efficacy Results

Efficacy results are presented in Efficacy Results.

Efficacy Results1,2

Endpoint

Ramucirumab + BSC
(n=197)

Placebo + BSC
(n=95)

Median OS, months

8.5

7.3

HR (95% CI); p value

0.710 (0.531-0.949); p=.0199

12-month OS, %

36.8

30.3

18-month OS, %

24.5

11.3

Median PFS, months

2.8

1.6

HR (95% CI); p value

0.452 (0.339-0.603); p<.0001a

ORR (95% CI), %b

4.6 (1.7-7.5)

1.1 (0.0-3.1)

CR, n (%)

0 (0.0)

0 (0.0)

PR, n (%)

9 (4.6)

1 (1.1)

SD, n (%)

109 (55.3)

36 (37.9)

DCR (95% CI), %b

59.9 (53.1-66.7)

38.9 (29.1-48.8)

P value

p=.0006a

Abbreviations: BSC = best supportive care; CR = complete response; DCR = disease control rate; HR = hazard ratio; ORR = objective response rate; OS = overall survival; PFS = progression-free survival; PR = partial response, RECIST = Response Evaluation Criteria in Solid Tumors; SD = stable disease; v = version.

aP value is calculated by exact Cochran-Mantel-Hanszel test stratified by the randomization strata.

bTumor assessment based on RECIST, v1.1.

Safety Results

Treatment-emergent adverse events that occurred in at least 15% of patients in the ramucirumab arm are presented in Treatment-Emergent Adverse Events in ≥15% of Patients in the Ramucirumab Arm.

Treatment-Emergent Adverse Events in ≥15% of Patients in the Ramucirumab Arm1

TEAE, n (% of patients)

Any Grade

Grade ≥3

Any Grade

Grade ≥3

Ramucirumab + BSC 
(n=197)

Placebo + BSC
(n=95)

Liver injury/failure

78 (40)

36 (18)

28 (29)

15 (16)

Fatigue

54 (27)

7 (4)

16 (17)

3 (3)

Peripheral edema

50 (25)

3 (2)

13 (14)

0

Hypertension

49 (24)

25 (13)

12 (13)

5 (5)

Decreased appetite

46 (24)

3 (2)

19 (20)

1 (1)

Bleeding/hemorrhagic events

48 (24)

10 (5)

12 (13)

3 (3)

Proteinuria

40 (20)

4 (2)

4 (4)

0

Abdominal pain

39 (20)

3 (2)

12 (13)

2 (2)

Nausea

37 (19)

0

11 (12)

0

Ascitesa

35 (18)

8 (5)

7 (7)

2 (2)

Diarrhea

32 (16)

0

14 (15)

1 (1)

Abbreviations: BSC = best supportive care; TEAE = treatment-emergent adverse events.

aPreferred term.

Reference

1Zhu AX, Kang YK, Yen CJ, et al. Ramucirumab after sorafenib in patients with advanced hepatocellular carcinoma and increased α-fetoprotein concentrations (REACH-2): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2019;20(2):282-296. http://dx.doi.org/10.1016/S1470-2045(18)30937-9

2Zhu 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

Glossary

AFP = alpha-fetoprotein

BSC = best supportive care

ECOG = Eastern Cooperative Oncology Group

HCC = hepatocellular carcinoma

OS = overall survival

PS = performance status

Fecha de la última revisión: 2021 M01 07


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