Cyramza ® (ramucirumab)

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Cyramza® (ramucirumab): Tidigare behandling i REACH-2

Alla patienter som deltog i REACH-2 var tidigare behandlade med sorafenib.

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 

Prior Therapy

Prior anticancer therapy administered to patients enrolled in the REACH-2 study are summarized in Table 1.

Table 1. Prior Therapy and Surgery for Hepatocellular Carcinoma ITT Population2

Prior Anticancer Therapy 

Ramucirumab + BSC
(n=197)
n (%) 

Placebo + BSC
(n=95)
n (%)

Total
(n=292)
n (%)

Surgical Procedure 

87 (44.2) 

39 (41.1)

126 (43.2)

Curative intent 

67 (34.0) 

29 (30.5)

96 (32.9)

Palliative intent 

21 (10.7) 

13 (13.7)

34 (11.6)

Radiotherapy

36 (18.3) 

19 (20.0)

55 (18.8)

Curative intent

10 (5.1)

6 (6.3)

16 (5.5)

Palliative intent

26 (13.2)

14 (14.7)

40 (13.7)

Systemic Therapy

197 (100)

95 (100)

292 (100)

Sorafenib

197 (100)

95 (100)

292 (100)

Investigational drug

1 (0.5)

0

1 (0.3)

Uracil/tegafur

1 (0.5)

0

1 (0.3)

Abbreviations: BSC = best supportive care; ITT = intent-to-treat.  

No efficacy or safety data by prior therapy is available. 

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

HCC = hepatocellular carcinoma

ECOG = Eastern Cooperative Oncology Group

PS = performance status

Datum fӧr senaste ӧversyn 2018 M07 01

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