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 
(n=221)

Placebo + Erlotiniba
(n=225)

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.

References

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. https://doi.org/10.1016/S1470-2045(19)30634-5

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

Glossary

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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