Cyramza ® (ramucirumab)

För fullständig produktresumé för Cyramza® se FASS.

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Cyramza® (ramucirumab): RELAY Dosrational

Säkerhet och tolerabilitet för 10 mg/kg ramucirumab varannan vecka i kombination med erlotinib 150 mg/dagligen bekräftades i del A (fas 1b) i RELAY-studien.

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

Rationale for Dose Selection

Ramucirumab

At the time of study design, the choice of the ramucirumab dose regimen in RELAY was informed by exposure-response findings from prior, randomized, second-line phase 3 ramucirumab studies and PK simulations from REVEL. This exposure-response analysis demonstrated that increased ramucirumab exposure is associated with improvement in OS and PFS and remains consistent with the established safety profile for ramucirumab. The frequency of dosing was selected to help ensure that exposure levels do not fall too low, as could occur with less frequent administration.  The safety and tolerability of 10 mg/kg every two week ramucirumab in combination with erlotinib 150mg/daily was confirmed in part A (phase 1b) of the RELAY study. Existing data do not support exploring an approach that extends the interval between administrations as a means to improve patient outcomes.2 

Erlotinib

At the time of study design, there were 3 EGFR TKIs (erlotinib, gefitinib and afatinib) approved for use as first-line treatment of NSCLC with EGFR activating mutations; only erlotinib was globally-approved and a recommended TKI for this indication according to ESMO, NCCN, and The Japan Lung Cancer Society guidelines. No head-to-head studies had been performed which would indicate that one TKI had superior efficacy to another and the safety profiles were similar.2

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

AE = adverse event

Cmin,ss = minimum concentration at steady state

ECOG = Eastern Cooperative Oncology Group

EGFR = epidermal growth factor receptor

ESMO = European Society for Medical Oncology

NCCN = National Comprehensive Cancer Network

NSCLC = non-small cell lung cancer

OS = overall survival

PFS = progression-free survival

PK = pharmacokinetic(s)

PS = performance status

TKI = tyrosine kinase inhibitor

Datum fӧr senaste ӧversyn 2019 M07 20


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