Cyramza ® (ramucirumab)

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Cyramza® (ramucirumab): 12, 18 och 24-månaders överlevnad i REACH-2

I REACH-2 var överlevnaden efter 12 månader 36,8% jämfört med 30,3%, efter 24 månader 10,2% jämfört med 0% för ramucirumab plus bästa understödjande behandling jämfört med placebo plus bästa understödjande behandling, respektive.

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 

Survival Results

The OS rate at 12, 18, and 24 months for patients in the REACH-2 study is presented in Table 1.

Table 1. Overall Survival at 1 and 2 Years in the REACH-2 Study2 

Endpoint

Ramucirumab + BSC
(n=197)

Placebo + BSC
(n=95)

12-month overall survival (95% CI)

36.8 (29.8-43.8) 

30.3 (20.8-40.3)

18-month overall survival (95% CI)

24.5 (18.0-31.6)

11.3 (4.6-21.5)

24-month overall survival (95% CI)

10.2 (4.6-18.3) 

0

Abbreviation: BSC = best supportive care. 

Safety Results

Treatment-emergent adverse events that occurred in at least 15% of patients in the ramucirumab arm are presented in Table 2.

Table 2. 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 
(n=197)

Placebo + BSC
(n=95)

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.

References

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

HCC = hepatocellular carcinoma

OS = overall survival

PS = performance status

Datum fӧr senaste ӧversyn 2018 M07 01

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