Cyramza® (Ramucirumab)

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Ramucirumab: Efficacy and Safety According to Gender in RELAY

En el estudio RELAY, no se observaron diferencias significativas en eficacia entre los participantes masculinos y femeninos y el perfil de seguridad entre los brazos de tratamiento fue consistente con el observado en la población de seguridad general.

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 Gender

Among patients who received ramucirumab plus erlotinib

  • 83 (37%) were male, and

  • 141 (63%) were female.

Among patients who received placebo plus erlotinib

  • 83 (37%) were male, and

  • 142 (63%) were female.2

Efficacy According to Gender

No significant differences in efficacy were observed between the gender subgroups.2 Efficacy results according to gender are summarized in Table 1.

Table 1. Efficacy Results According to Gender in RELAY3

 

Ramucirumab + Erlotinib
(n=83)

Placebo + Erlotinib
(n=83)

Ramucirumab + Erlotinib
(n=141)

Placebo + Erlotinib
(n=142)

Male

Female

Median PFSa, mo (95% CI)

19.6 (15.2-22.4)

10.9 (8.3-12.5)

18.0 (14.7-21.6)

12.6 (11.1-15.5)

HRb (95% CI); p valuec

0.505 (0.342-0.747); p=.0005 

0.731 (0.541-0.988); p=.0407

Interaction p valued

p=.1678 

Abbreviations: HR = hazard ratio; PFS = progression-free survival.

a Estimated using the Kaplan-Meier method.

b Hazard ratio and 95% CI (Wald) were estimated from unstratified Cox model.

c Two-sided p value from unstratified log-rank test.

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

Safety According to Gender

The safety profile within gender subgroups between treatment arms was consistent with that observed in the overall safety population.3 The majority of differences in incidences of specific TEAEs between female and male patients were observed in low-grade (Grades 1-2) events. A higher proportion (a difference of at least 5 percentage points) of female patients compared to male patients experienced Grade ≥3 laboratory hepatic events, independent of treatment arm. No other clinically relevant differences were seen in terms of TEAE profile between treatment arms within subgroups or across female and male subgroups.3 Any grade TEAEs that occurred in at least 20% of patients in the ramucirumab arm are summarized in Table 2.

Table 2. Any Grade TEAEs in ≥20% of Patients Who Received Ramucirumab Plus Erlotinib in the Gender Subgroup in RELAY3

TEAE, % of Patients

Ramucirumab + Erlotinib
(n=82)

Placebo + Erlotinib
(n=83)

Ramucirumab + Erlotinib
(n=139)

Placebo + Erlotinib
(n=142)

Male 

Female 

Dermatitis acneiform

75.6

61.4

62.6

71.8

Diarrhea 

64.6

69.9

73.4

71.8

Paronychia

56.1

48.2

51.8

52.1

Hypertension

39.0

16.9

48.9

9.2

Epistaxis

36.6

14.5

31.7

10.6

Blood bilirubin increased

35.4

38.6

28.1

26.8

ALT increased

35.4

34.9

46.8

28.9

AST increased

35.4

27.7

45.3

24.6

Proteinuria

32.9

8.4

34.5

8.5

Dry skin

31.7

32.5

41.0

45.1

Stomatitis

30.5

31.3

48.2

39.4

Pruritus

25.6

30.1

21.6

28.9

Constipation

24.4

16.9

16.5

12.7

Cough

24.4

13.3

20.1

16.9

Decreased appetite

23.2

18.1

27.3

22.5

Nausea

23.2

12.0

27.3

23.9

Platelet count decreased

23.2

1.2

8.6

3.5

Pyrexia

20.7

9.6

21.6

14.1

Upper respiratory tract infection

20.7

9.6

15.1

18.3

Alopecia

18.3

13.3

43.2

23.2

Peripheral edema

15.9

2.4

26.6

5.6

Rash

13.4

27.7

20.1

21.8

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

References

1. Nakagawa 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

2. Nakagawa 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

3. Data 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

PS = performance status

TEAE = treatment-emergent adverse event

Fecha de la última revisión: 2019 M10 22


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