Cyramza® (Ramucirumab)

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Ramucirumab: One and Two Year Survival Rates in REVEL

In REVEL, 1-yr OS was 43% vs 38%; 2-yr OS was 21% vs 18%, for ramucirumab plus docetaxel vs placebo plus docetaxel, respectively.


The information contained in this letter may not completely match the current local labeling for RAMUCIRUMAB. Please see local labeling approved in your country.

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

Survival Results

The OS rate at 1 and 2 years is presented in Overall Survival at 1 and 2 Years in the REVEL Study.

Overall Survival at 1 and 2 Years in the REVEL Study2


Ramucirumab + Docetaxel

Placebo + Docetaxel

1-year overall survival, % (95% CI)

42.9 (38.9-46.9)

37.7 (33.8-41.5)

2-year overall survival, % (95% CI)

20.9 (17.0-25.1)

17.5 (13.8-21.5)

Safety Results

In the ramucirumab-plus-docetaxel group compared to the placebo-plus-docetaxel group

  • grade ≥3 TEAEs were reported in 495 (79%) patients vs 444 (71%) patients 
  • TEAEs with an outcome of death were reported in 34 (5%) patients vs 35 (6%) patients, and
  • dose adjustments occurred in 204 (33%) of 627 patients vs 139 (23%) of 618 patients.1

TEAEs (including all grades) for which there was a ≥5% higher incidence in the ramucirumab-plus-docetaxel group than in the placebo-plus-docetaxel group were neutropenia, febrile neutropenia, thrombocytopenia, stomatitis, mucosal inflammation, peripheral edema, increased lacrimation, fatigue, diarrhea, and hypertension; bleeding/hemorrhage events overall, and epistaxis.1


1Garon 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.

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


ECOG = Eastern Cooperative Oncology Group

NSCLC = non-small cell lung cancer

OS = overall survival

PS = performance status

TEAE = treatment-emergent adverse event

Fecha de la última revisión: 2019 M11 20

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