Cyramza® (Ramucirumab)

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Ramucirumab: Efficacy and Safety According to Age in RELAY

In RELAY, PFS treatment benefit for ramucirumab plus erlotinib was observed for patients <65 and ≥65 years and the safety profile of both age groups between treatment arms was consistent with that observed in the overall safety population.

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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 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 status, and EGFR testing method) to receive treatment with erlotinib (150 mg/day) plus ramucirumab (10 mg/kg every 2 weeks; n=224) or placebo (10 mg/kg every 2 weeks; n=225) until disease progression or unacceptable toxicity.1

Enrollment According to Age

In RELAY, the median patient age was 65 years in the ramucirumab plus erlotinib group and 64 years in the placebo plus erlotinib group.2 Additional details on patient age are summarized in Age Groups Represented in RELAY.

Age Groups Represented in RELAY3

 

Ramucirumab + Erlotinib
(N=224) 

Placebo + Erlotinib
(N=225)

Total
(N=449)

Median age, years (range)

65 (27-86)

64 (23-89)

65 (23-89)

Age Group, n (%)

 <65 years

102 (45.5)

114 (50.7)

216 (48.1)

 ≥65 years

122 (54.5)

111 (49.3)

233 (51.9)

  65 to <75 years

93 (41.5)

82 (36.4)

175 (39.0)

 ≥75 years

29 (12.9)

29 (12.9)

58 (12.9)

  75 to <85 years

28 (12.5)

28 (12.4)

56 (12.5)

 ≥85 years

1 (0.4)

1 (0.4)

2 (0.4)

Efficacy According to Age

A prespecified subgroup analysis of PFS was performed to evaluate treatment effect in patients <65 vs ≥65 years of age. A PFS treatment benefit for the ramucirumab plus erlotinib arm was observed in both age subgroups as summarized in Efficacy Results According to Age in RELAY.

Efficacy Results According to Age in RELAY2,3

 

Ramucirumab + Erlotinib
(n=102)

Placebo + Erlotinib
(n=114)

Ramucirumab + Erlotinib
(n=122)

Placebo + Erlotinib
(n=111)

Age <65 Years

Age ≥65 Years

Median PFSa, mo (95% CI)

20.6 (15.1-22.2)

12.5 (11.1-13.6)

19.2 (15.1-21.9)

11.1 (9.1-19.2)

HRb (95% CI); p valuec

0.534 (0.382-0.745); p=.0002 

0.771 (0.547-1.088); p=.1388

Interaction p valued

p=.2085 

Abbreviations: HR = hazard ratio; NS = not significant; PFS = progression-free survival.

aEstimated using the Kaplan-Meier method.

bHazard ratio and 95% CI (Wald) were estimated using an unstratified Cox model.

cTwo-sided p-value from unstratified log-rank test.

dWald test of treatment-by-subgroup interaction from unstratified Cox model.

Safety According to Age

The safety profile of patients <65 and ≥65 years of age between treatment arms was consistent with that observed in the overall safety population.3 There was a trend toward higher incidences of specific TEAEs in patients 65 years and older compared to patients younger than 65 years of age, independent of treatment arm. No other clinically meaningful differences were seen in the TEAE profile between age subgroups.3 Any grade TEAEs that occurred in at least 20% of patients in the ramucirumab arm are summarized in Any Grade TEAEs in ≥20% of Patients Who Received Ramucirumab Plus Erlotinib in RELAY.

Any Grade TEAEs in ≥20% of Patients Who Received Ramucirumab Plus Erlotinib in RELAY3

TEAE, % of Patients

Ramucirumab + Erlotinib
(n=102)

Placebo + Erlotinib
(n=114)

Ramucirumab + Erlotinib
(n=119)

Placebo + Erlotinib
(n=111)

Age <65 years 

Age ≥65 years 

Dermatitis acneiform

66.7

64.0

68.1

72.1

Diarrhea

64.7

70.2

74.8

72.1

Paronychia

54.9

51.8

52.1

49.5

Hypertension

40.2

7.0

49.6

17.1

Stomatitis

36.3

45.6

46.2

27.0

Dry skin

35.3

43.9

39.5

36.9

ALT increased

35.3

31.6

48.7

30.6

AST increased

33.3

27.2

48.7

24.3

Alopecia

33.3

23.7

34.5

15.3

Epistaxis

32.4

14.9

34.5

9.0

Proteinuria

30.4

8.8

37.0

8.1

Blood bilirubin increased

29.4

30.7

31.9

31.5

Pruritus

28.4

33.3

18.5

25.2

Nausea

21.6

18.4

29.4

20.7

Cough

21.6

17.5

21.8

13.5

Upper respiratory tract infection

20.6

18.4

14.3

11.7

Pyrexia

19.6

13.2

22.7

11.7

Decreased appetite

18.6

14.9

31.9

27.0

Peripheral edema

17.6

0.9

26.9

8.1

Constipation

16.7

12.3

21.8

16.2

Dysgeusia

11.8

9.6

22.7

18.9

Abbreviations: ALT = alanine aminotransferase; AST = aspartate aminotransferase; TEAE = treatment-emergent adverse event.

References

1Nakagawa K, Garon E, Seto T, et al. RELAY: A multicenter, double-blind, randomized, phase 3 study of erlotinib (ERL) in combination with ramucirumab (RAM) or placebo (PL) in previously untreated patients with epidermal growth factor receptor (EGFR) mutation-positive metastatic non-small cell lung cancer (NSCLC). Talk presented at: 55th Annual Meeting of the American Society of Clinical Oncology (ASCO); May 31-June 4, 2019; Chicago, IL. https://meetinglibrary.asco.org/record/173373/abstract

2Nakagawa 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

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

Glossary

ECOG = Eastern Cooperative Oncology Group

EGFR = epidermal growth factor receptor

NSCLC = non-small cell lung cancer

PFS = progression-free survival

PS = performance status

TEAE = treatment-emergent adverse event

Fecha de la última revisión: 2019 M10 22


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