Cyramza® (Ramucirumab)

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Ramucirumab: Efficacy Outcomes Among Patients Who Received Prior Taxane in REVEL

In the REVEL study, no significant difference in OS was observed between patients who received prior taxane and those who did not.

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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

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).1

Protocol Requirements Related to Prior Taxane Therapy

Patients were excluded from the REVEL trial if they had received prior therapy with docetaxel.1

Efficacy

Overall and Progression-Free Survival Results According to Prior Taxane Therapy   describes the OS and PFS results according to prior taxane therapy in the REVEL study.

Overall and Progression-Free Survival Results According to Prior Taxane Therapy2  

  

RAM + DOC
(n=153)

PBO + DOC
(n=149)

RAM + DOC
(n=475)

PBO + DOC
(n=476)

Prior Taxane

No Prior Taxane

Median OS, mo (95% CI)

10.81 (8.90-12.42)

10.35 (7.82-12.12)

10.32 (9.30-11.27)

9.03 (8.05-9.79)

HR (95% CI)

0.81 (0.62-1.07); p=NS

0.87 (0.75-1.01); p=NS

Interaction p value

NS

Median PFS, mo (95% CI)

4.44 (3.61-5.52)

3.61 (2.76-4.30)

4.50 (4.17-5.39)

2.92 (2.76-3.81)

HR (95% CI)

0.90 (0.71-1.15); p=NS

0.74 (0.64-0.84); p<.001

Interaction p value

NS

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

Safety

Any Grade Treatment-Emergent Adverse Events in ≥20% of Patients Who Received Ramucirumab Plus Docetaxel According to Prior Taxane   describes any grade TEAEs that occurred in at least 20% of patients in the ramucirumab plus docetaxel arm (summarized according to prior taxane). Grade ≥3 Treatment-Emergent Adverse Events in ≥10% of Patients Who Received Ramucirumab Plus Docetaxel 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).

Any Grade Treatment-Emergent Adverse Events in ≥20% of Patients Who Received Ramucirumab Plus Docetaxel According to Prior Taxane2  

Any Grade TEAE, Regardless of Causalitya  

RAM + DOC
(n=154)
% of Patients

PBO + DOC
(n=147)
% of Patients

RAM + DOC
(n=473)
% of Patients

PBO + DOC
(n=471)
% of Patients

Prior Taxane 

No Prior Taxane 

Fatigue

44.2

36.7

46.7

43.3

Neutropenia

41.6

40.1

38.1

31.0

Nausea

29.9

29.9

26.0 

26.8

Diarrhea

29.2

29.9

32.6 

27.0

Decreased appetite

27.9

27.9

29.4

24.0

Dyspnea

22.7

25.2

21.8 

23.8

Anemia

21.4

28.6

20.7

27.4

Cough

17.5

20.4

22.4 

20.8

Alopecia

14.9

14.3

29.4

28.7

Stomatitis 

18.8

6.8

24.7

14.9

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

aMedDRA preferred term.

Grade ≥3 Treatment-Emergent Adverse Events in ≥10% of Patients Who Received Ramucirumab Plus Docetaxel According to Prior Taxane2 

Grade ≥3 TEAE, Regardless of Causalitya  

RAM + DOC
(n=154)
% of Patients

PBO + DOC
(n=147)
% of Patients

RAM + DOC
(n=473)
% of Patients

PBO + DOC
(n=471)
% of Patients

Prior Taxane 

No Prior Taxane 

Fatigue

13.6 

6.1

10.6 

8.7

Neutropenia

36.4 

29.9

34.5 

27.4

Neutrophil count decreased

15.6

11.6

15.4

13.6

Febrile neutropenia

13.6

12.9

16.7

9.1

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

aMedDRA preferred term.

References

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. http://dx.doi.org/10.1016/S0140-6736(14)60845-X

2Data 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

Fecha de la última revisión: 2019 M12 06


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