Cyramza ® (ramucirumab)

För fullständig produktresumé för Cyramza® se FASS.

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Cyramza® (ramucirumab): Förekomst av pneumonit i RELAY

Data för interstitiell lungsjukdom och pneumonit presenteras då dessa är relaterade och tidigare associerade med EGFR-tyrosinkinashämmare.

Study Design

The RELAY trial was a phase 3, global, multicenter, randomized, double-blind, placebo-controlled trial in patients (N=449) with previously untreated EGFR mutation-positive, metastatic NSCLC. All patients had an EGFR mutation of exon 19 deletion or exon 21 L858R and an ECOG PS of 0 or 1. Patients were randomly assigned in a 1:1 ratio (stratified by sex, region, EGFR status, and EGFR testing method) to receive treatment with erlotinib (150 mg/day) plus ramucirumab (10 mg/kg every 2 weeks; n=224) or placebo (10 mg/kg every 2 weeks; n=225) until disease progression or unacceptable toxicity.1

Incidence of Pneumonitis/Interstitial Lung Disease

Treatment-emergent adverse events of pneumonitis and ILD are presented in Table 1.

Table 1. Treatment-Emergent Adverse Events of Pneumonitis and Interstitial Lung Disease in the Safety Population in RELAY1,2

TEAE, n (% of patients)

Any Grade

Grade ≥3

Any Grade

Grade ≥3

Ramucirumab + Erlotinib 

Placebo + Erlotiniba

ILD or Pneumonitisb

4 (2)

1 (<1)

7 (3)

3 (1)

Abbreviations: EGFR = epidermal growth factor receptor; ILD = interstitial lung disease; n=number of patients; TEAE = treatment-emergent adverse events.

a One patient in the placebo group had a fatal event of ILD more than 30 days after treatment discontinuation.

b Data for ILD and pneumonitis are here because these are related and previously associated with EGFR tyrosine kinase inhibitors.

A similar proportion of Asian and non-Asian patients had ILD that included

  • 9 (3%) of 344 Asian patients, and

  • 2 (2%) of 102 non-Asian patients.1

Due to the small sample size of patients who developed ILD/pneumonitis while on study, no specific efficacy analyses was performed for these patients.


1. Nakagawa K, Garon EB, Seto T, et al. Ramucirumab plus erlotinib in patients with untreated, EGFR-mutated, advanced non-small-cell lung cancer (RELAY): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2019;20(12):1655-1669.

2. Data on file, Eli Lilly and Company and/or one of its subsidiaries.


ECOG = Eastern Cooperative Oncology Group

EGFR = epidermal growth factor receptor

ILD = interstitial lung disease

NSCLC = non-small cell lung cancer

PS = performance status

Datum fӧr senaste ӧversyn 2019 M10 11

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