Cyramza® (ramucirumab): EGFR-ALK testning före REVEL

Study Design

The REVEL trial was a phase 3, multicenter, randomized, double-blind, placebo-controlled trial in patients with pathologically confirmed, squamous or nonsquamous, stage IV NSCLC with disease progression during or after 1 prior platinum-based chemotherapy. Prior treatment with bevacizumab and prior maintenance therapy were allowed and all patients had an ECOG PS of 0 or 1. Patients were randomly assigned in a 1:1 ratio (stratified by sex, region, PS, and previous maintenance therapy) to receive treatment with ramucirumab (10 mg/kg every 3 weeks) plus docetaxel (75 mg/m² every 3 weeks) (n=628) or placebo plus docetaxel (75 mg/m² every 3 weeks) (n=625) until disease progression, unacceptable toxicity, withdrawal, or death.¹

Testing for EGFR in the REVEL Study

In the REVEL study, patients with known EGFR-positive mutation status and those who received prior therapy with TKIs were eligible as long as they were treated with prior platinum-based chemotherapy.¹ During enrollment in the REVEL trial, it was not required for patients to be tested for EGFR and ALK biomarkers.² In addition, patients were excluded from REVEL if their only prior treatment for advanced disease was a TKI (eg, erlotinib).¹

Testing for ALK in the REVEL Study

At the time of initial patient enrollment (2010), no agents were approved for treating patients with ALK translocations, which constitute less than 5% of all NSCLC patients,³ and neither the test nor the ALK testing guidelines were available in routine clinical practice. Therefore, data regarding ALK status were not collected in this study.²

References

1. Garon EB, Ciuleanu TE, Arrieta O, et al. Ramucirumab plus docetaxel versus placebo plus docetaxel for second-line treatment of stage IV non-small-cell lung cancer after disease progression on platinum-based therapy (REVEL): a multicentre, double-blind, randomised phase 3 trial. Lancet. 2014;384(9944):665-673. http://dx.doi.org/10.1016/S0140-6736(14)60845-X

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

3. Chia PL, Mitchell P, Dobrovic A, John T. Prevalence and natural history of ALK positive non-small-cell lung cancer and the clinical impact of targeted therapy with ALK inhibitors. Clin Epidemiol. 2014;6:423-432. http://dx.doi.org/10.2147/CLEP.S69718.

Glossary

ALK = anaplastic lymphoma kinase 

ECOG = Eastern Cooperative Oncology Group

EGFR = epidermal growth factor receptor

NSCLC = non-small cell lung cancer

PS = performance status

TKI = tyrosine kinase inhibitor