Cyramza ® (ramucirumab)

För fullständig produktresumé för Cyramza® se FASS.

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Cyramza® (ramucirumab): Behandlingstid i RELAY

Medianvaraktigheten av behandling med ramucirumab var längre än placebo, och medianvaraktigheten av behandling med erlotinib var längre i ramucirumab plus erlotinib-armen än i placebo plus erlotinib-armen.

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

Treatment Duration

The median duration of ramucirumab treatment was longer than that of placebo and the median duration of erlotinib treatment was longer in the ramucirumab plus erlotinib arm than in the placebo plus erlotinib arm.2 Additional details on treatment duration are summarized in Table 1.

Table 1. Duration of Treatmenta2 

 

Ramucirumab + Erlotinib
n=221

Erlotinib + Placebo
n=225

Ramucirumab or Placebob

Median duration of therapy, months (range)

11.04 (0.46-33.81)

9.66 (0.46-35.42)

Median infusions received per patient (range)

21.00 (1.00-69.00)

19.00 (1.00-74.00)

Erlotinibb

Median duration of therapy, months (range)

14.13 (0.03-33.84)

11.20 (0.36-35.45)

Median weeks on treatment per patient (range)c

60.00 (0-138.00)

47.00 (1.00-152.00)

a Data cutoff date: 23 January 2019.

b Number of patients who received at least one dose of study drug ramucirumab or placebo or erlotinib, either partial or complete.

c Patient is considered to have received a week of therapy after receiving at least 7 doses of erlotinib, either partial or complete.

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

NSCLC = non-small cell lung cancer

PS = performance status

Datum fӧr senaste ӧversyn 2019 M07 24


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