Cyramza® (Ramucirumab)

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Ramucirumab: Safety Data on Use in Patients with NSCLC in Combination with Docetaxel

The most common all-grade AEs in patients who received ramucirumab were neutropenia, fatigue/asthenia, and stomatitis in REVEL and infections, diarrhea, and hypertension in RELAY.

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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.

Use in Treatment of Non-Small Cell Lung Cancer

Ramucirumab, in combination with

  • docetaxel, is indicated for the treatment of patients with locally advanced or metastatic NSCLC with disease progression after platinum-based chemotherapy, or
  • erlotinib, is indicated for the first-line treatment of patients with metastatic NSCLC with activating EGFR mutations.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

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 mutation type, and EGFR testing method) to receive treatment with erlotinib (150 mg/day) plus ramucirumab (10 mg/kg every 2 weeks; n=224) or placebo (every 2 weeks; n=225) until disease progression or unacceptable toxicity.3

Safety

REVEL Study

The frequency and severity of adverse reactions that have been reported at an incidence rate of ≥5% in patients who received ramucirumab in combination with docetaxel in the REVEL study are summarized in Adverse Reactions that Occurred at an Incidence Rate of ≥5% in Patients Who Received Ramucirumab in Combination With Docetaxel in the REVEL Trial.

Adverse Reactions that Occurred at an Incidence Rate of ≥5% in Patients Who Received Ramucirumab in Combination With Docetaxel in the REVEL Trial1,2

Adverse Reactions (MedDRA)
System Organ Class 

All Grades
(Frequency %)

Grade ≥3
(Frequency %)

All Grades
(Frequency %)

Grade ≥3
(Frequency %)

Ramucirumab + Docetaxel
(n=627)

Placebo + Docetaxel
(n=618)

Blood and lymphatic system disorders

Febrile neutropenia

15.9

15.9

10.0

10.0

Neutropenia

55.0

48.8

46.0

39.8

Thrombocytopenia

13.4

2.9

5.2

0.6

Gastrointestinal disorders

Stomatitis

23.3

4.3

12.9

1.6

General disorders and administration-site disorders

Fatigue/Asthenia

54.7

14.0

50.0

10.5

Mucosal inflammation

16.1

2.9

7.0

0.5

Peripheral edema

16.3

0

8.6

0.3

Respiratory, thoracic, and mediastinal disorders

Epistaxis

18.5

0.3

6.5

0.2

Vascular disorders

Hypertension

10.8

5.6

4.9

2.1

Abbreviation: MedDRA = Medical Dictionary for Regulatory Activities.

RELAY Study

The frequency and severity of adverse reactions that have been reported at an incidence rate of ≥5% in patients who received ramucirumab in combination with erlotinib in the RELAY study are summarized in Adverse Reactions that Occurred at an Incidence Rate of ≥5% in Patients who Received Ramucirumab in Combination with Erlotinib in the RELAY Trial.

Adverse Reactions that Occurred at an Incidence Rate of ≥5% in Patients who Received Ramucirumab in Combination with Erlotinib in the RELAY Trial1,3

Adverse Reactions (MedDRA)
System Organ Class

All Grades
(Frequency %)

Grade ≥3
(Frequency %)

All Grades
(Frequency %)

Grade ≥3
(Frequency %)

Ramucirumab + Erlotinib
(n=221)

Placebo + Erlotinib
(n=225)

Blood and lymphatic system disorders

Thrombocytopenia

16.3

1.4

2.7

0

Neutropenia

12.7

2.7

8.0

1.3

Anemia

10.0

1.8

4.9

0.4

Gastrointestinal disorders

Diarrhea

70.1

7.2

71.1

1.3

Stomatitis

41.6

1.8

36.4

1.3

Gastrointestinal hemorrhage eventsa

10.4

1.4

2.7

0.4

Gingival bleeding

8.6

0

1.3

0

General disorders and administration site disorders

Peripheral edema

22.6

0.9

4.4

0

Infections and infestations

Infectionsb

80.5

17.2

76.0

6.7

Nervous system disorders

Headache

14.9

0.9

7.1

0

Renal and urinary disorders

Proteinuria

34.4

2.7

8.4

0

Respiratory, thoracic, and mediastinal disorders

Epistaxis

33.5

00

12.0

0

Pulmonary hemorrhage eventsc

6.8

0.5

1.8

0.4

Skin and subcutaneous tissue disorders

Alopeciad

33.9

NA

19.6

NA

Vascular disorders

Hypertension

45.2

23.5

12.0

5.3

Abbreviations: CTCAE = Common Terminology Criteria for Adverse Events; MedDRA = Medical Dictionary for Regulatory Activities; NA = not applicable. 

aMedDRA preferred terms included anal hemorrhage, hemorrhoidal hemorrhage hematochezia, lower gastrointestinal hemorrhage, rectal hemorrhage, small intestinal hemorrhage, melena, duodenal ulcer hemorrhage, and upper gastrointestinal hemorrhage.

bInfections include all preferred terms that are part of the System Organ Class Infections and Infestations. Most common (≥1%) grade ≥3 infections include pneumonia, cellulitis, paronychia, skin infection, and urinary tract infection.

cMedDRA preferred terms included hemoptysis, laryngeal hemorrhage, hemothorax, and pulmonary hemorrhage.

dGrade ≥3 does not exist in CTCAE.

References

1Data on file, Eli Lilly and Company and/or one of its subsidiaries.

2Garon 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

3Nakagawa 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

Glossary

AE = adverse event

ECOG = Eastern Cooperative Oncology Group

EGFR = epidermal growth factor receptor

NSCLC = non-small cell lung cancer

PS = performance status

Fecha de la última revisión: 2020 M02 28


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