Cyramza ® (ramucirumab)

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Cyramza® (ramucirumab): Immune-Checkpoint-Hämmare som PDT i REACH-2

Det är osannolikt att obalanser i efterföljande behandling påverkade överlevnaden eftersom en liknande andel av patienterna fick ICI eller immunmodulerande medel i ramucirumab-armen som i placebo-armen (6,6% jämfört med 6,3%).

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 

Immune-Checkpoint Inhibitors as Postdiscontinuation Treatment

A similar proportion of patients received immunotherapy or immunomodulatory agents in the ramucirumab vs placebo arm (6.6% vs 6.3%); therefore, it is unlikely that imbalances in PDT may have affected survival outcomes in REACH-2.2 A summary of immunotherapy or immunomodulatory agents utilized as PDT is summarized in Table 1.

Table 1. Postdiscontinuation Immunotherapy in the ITT Population2  

Postdiscontinuation Immunotherapy

Ramucirumab + BSC
(n=197)
n (%)

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

Total
(n=292)
n (%)

Immunotherapy/Immunomodulatory

13 (6.6)

6  (6.3)

19 (6.5)

Atezolizumab

1 (0.5)

1 (1.1)

2 (0.7)

CC-122

1 (0.5)

0 (0.0)

1 (0.3)

Ipilimumab

3 (1.5)

0 (0.0)

3 (1.0)

Lirilumab

1 (0.5)

0 (0.0)

1 (0.3)

Mogamulizumab

1 (0.5)

0 (0.0)

1 (0.3)

Monoclonal antibodies

0 (0.0)

1 (1.1)

1 (0.3)

Nivolumab

11 (5.6)

1 (1.1)

12 (4.1)

Peginterferon alfa-2a

1 (0.5)

0 (0.0)

1 (0.3)

Pembrolizumab

0 (0.0)

1 (1.1)

1 (0.3)

Thalidomide

1 (0.5)

2 (2.1)

3 (1.0)

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

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

ICI = immune checkpoint inhibitor

PDT = postdiscontinuation therapy

PS = performance status

Datum fӧr senaste ӧversyn 2018 M10 01


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