Cyramza ® (ramucirumab)

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Cyramza® (ramucirumab): REACH-2 vs REACH

Huvudskillnaden mellan studierna är att REACH-2-protokollet inkluderade bara patienter med en AFP basnivå av ≥400 ng/ml.

Study Designs

REACH-2

A multicenter, randomized, double-blind, placebo-controlled trial was conducted to compare ramucirumab plus BSC vs placebo plus BSC in patients with advanced HCC and elevated baseline AFP following first-line sorafenib.1

Patients were eligible for participation if they had

  • diagnosis of HCC (histological or radiological imaging confirmation)

  • BCLC stage C or stage B refractory or not amenable to locoregional therapy

  • Child-Pugh Class A

  • ECOG PS score of 0 or 1

  • baseline AFP ≥400 ng/mL

  • prior sorafenib treatment (discontinued due to progression or intolerance)

  • adequate hematologic, and

  • biochemical parameters.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 IV 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

REACH

A multicenter, randomized, double-blind, placebo-controlled trial was conducted in patients with advanced HCC following first-line treatment with sorafenib.2

Patients were eligible for participation if they had

  • diagnosis of HCC  (histological or radiological imaging confirmation)

  • BCLC stage C or stage B refractory or not amenable to locoregional therapy

  • Child-Pugh Class A

  • ECOG PS score 0 or 1

  • prior sorafenib treatment (discontinued due to progression or intolerance)

  • adequate hematological, and

  • biochemical parameters.2

Patients were randomly assigned in a 1:1 ratio (stratified by geographic region and etiology of liver disease) to receive ramucirumab (8 mg/kg IV every 2 weeks) plus BSC (n=283) or placebo (every 2 weeks) plus BSC (n=282) until disease progression, unacceptable toxicity, withdrawal of consent, or death.2

Study Comparisons

Similarities

Both REACH and REACH-2 trials

  • were global, multicenter, randomized, double-blind, placebo-controlled phase 3 studies in patients with

    • advanced HCC

    • treated previously with sorafenib

  • had a primary endpoint of OS

  • had secondary endpoints that included

    • PFS

    • TTP

    • ORR

    • safety, and

    • PRO.1,2

Difference

The main difference between the trials is that the REACH-2 protocol mandated inclusion of patients with baseline AFP levels ≥400 ng/mL only. This inclusion criterion was based on data from pre-specified and exploratory analyses of REACH showing that ramucirumab improved survival in the population of patients with baseline AFP ≥400 ng/mL.1,2

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. [DO NOT USE] xxZhu AX, xxPark JO, xxRyoo BY, et al. Ramucirumab versus placebo as second-line treatment in patients with advanced hepatocellular carcinoma following first-line therapy with sorafenib (REACH): a randomised, double-blind, multicentre, phase 3 trial. Lancet Oncol. 2015;16(7):859-870. http://dx.doi.org/10.1016/S1470-2045(15)00050-9. Accompanied by supplementary appendix https://ars.els-cdn.com/content/image/1-s2.0-S1470204515000509-mmc1.pdf available as a pdf file.

Glossary

AFP = alpha-fetoprotein

BCLC = Barcelona Clinic Liver Cancer

BSC = best supportive care

ECOG = Eastern Cooperative Oncology Group

HCC = hepatocellular carcinoma

IV = intravenous

ORR = overall response rate

OS = overall survival

PFS = progression-free survival

PRO = patient-reported outcome

PS = performance status

TTP = time-to-progression

Datum fӧr senaste ӧversyn 2018 M10 01


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