Cyramza® (ramucirumab): REVEL - Effekt vid tidigare taxanbehandling

Information from Summary of Product Characteristics

Cyramza in combination with docetaxel is indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer with disease progression after platinum-based chemotherapy.¹

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.²

In the REVEL study, 24% of patients in each arm received prior taxane therapy (n=153 in the ramucirumab plus docetaxel arm and n=149 in the placebo plus docetaxel arm).²

Protocol Requirements Related to Prior Taxane Therapy

Patients were excluded from the REVEL trial if they had received prior therapy with docetaxel.²

Efficacy

Table 1 describes the OS and PFS results according to prior taxane therapy in the REVEL study.

Table 1. Overall and Progression-Free Survival Results According to Prior Taxane Therapy³  

Abbreviations: DOC = docetaxel; HR = hazard ratio; NS = not significant; OS = overall survival; PBO = placebo; PFS = progression-free survival; RAM = ramucirumab. 

Safety

Table 2 describes any grade TEAEs that occurred in at least 20% of patients in the ramucirumab plus docetaxel arm (summarized according to prior taxane).   presents grade ≥3 TEAEs that occurred in at least 10% of patients in the ramucirumab plus docetaxel arm (summarized according to prior taxane).

Table 2. Any Grade Treatment-Emergent Adverse Events in ≥20% of Patients Who Received Ramucirumab Plus Docetaxel According to Prior Taxane³  

Abbreviations: DOC = docetaxel; MedDRA = Medical Dictionary of Regulatory Activities; PBO = placebo; RAM = ramucirumab; TEAE = treatment-emergent adverse event. 

^a MedDRA preferred term.

Table 3. Grade ≥3 Treatment-Emergent Adverse Events in ≥20% of Patients who Received Ramucirumab Plus Docetaxel According to Prior Taxane³ 

Abbreviations: DOC = docetaxel; MedDRA = Medical Dictionary of Regulatory Activities; PBO = placebo; RAM = ramucirumab; TEAE = treatment-emergent adverse event. 

^a MedDRA preferred term.

References

1. Cyramza [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.

2. 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

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

Glossary

ECOG = Eastern Cooperative Oncology Group

NSCLC = non-small cell lung cancer

OS = overall survival

PFS = progression-free survival

PS = performance status

TEAE = treatment-emergent adverse event