Cyramza® (Ramucirumab)

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Ramucirumab: 12, 18, and 24-Month Survival in RELAY

In RELAY 12-mo PFS was 71.9% vs 50.7%; 24-mo PFS was 32.4% vs 22.9%, for ramucirumab plus erlotinib vs placebo plus erlotinib, respectively.

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MX_cFAQ_RAM136_RELAY_EFFICACY_AFTER_12MONTHS
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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

Survival Results

In RELAY, the median follow-up time was 20.7 months (range 0.1-35.4 months), as measured from randomization to death or last known alive date.2 The PFS rate at 12, 18, and 24 months for patients in the RELAY study is presented in Investigator-Assessed Progression-Free Survival at 12-, 18-, and 24-months  in RELAY.

Investigator-Assessed Progression-Free Survival at 12-, 18-, and 24-months  in RELAY2

Endpoint

Ramucirumab + Erlotinib
(n=224)

Placebo + Erlotinib
(n=225)

12-month overall survival (95% CI)

71.9 (65.1-77.6)

50.7 (43.7-57.3)

18-month overall survival (95% CI)

52.4 (44.8-59.5)

34.5 (27.9-41.3)

24-month overall survival (95% CI)

32.4 (24.5-40.5)

22.9 (16.8-29.7)

At the time of data cut-off, the OS results were immature with 79 deaths and a censoring rate of more than 80% (data maturity, 17.6%).2

Safety Results

Treatment-emergent adverse events that occurred in at least 15% of patients in the ramucirumab arm are presented in Treatment-Emergent Adverse Events in ≥15% of Patients in the Ramucirumab Arm in RELAY.

Treatment-Emergent Adverse Events in ≥15% of Patients in the Ramucirumab Arm in RELAY2

TEAE, % of Patients

Any Grade

Grade ≥3

Any Grade

Grade ≥3

Ramucirumab + Erlotinib 
(n=221)

Placebo + Erlotinib
(n=225)

Diarrhea

70.1

7.2

71.1

1.3

Dermatitis acneiform

67.4

14.9

68.0

8.9

Paronychia

53.4

4.1

50.7

3.1

Hypertension

45.2

23.5

12.0

5.3

ALT increased

42.5

8.6

31.1

7.6

Stomatitis

41.6

1.8

36.4

1.3

AST increased

41.6

5.0

25.8

4.4

Dry skin

37.6

0.5

40.4

2.2

Alopecia

33.9

NA

19.6

NA

Proteinuria

33.9

2.7

8.4

0

Epistaxis

33.5

0

12.0

0

Blood bilirubin increased

30.8

1.4

31.1

0.9

Decreased appetite

25.8

2.7

20.9

1.8

Nausea

25.8

0.9

19.6

0.9

Pruritus

23.1

0.9

29.3

0.9

Peripheral edema

22.6

0.9

4.4

0

Cough

21.7

0.5

15.6

0

Pyrexia

21.3

0

12.4

0.4

Constipation

19.5

0

14.2

0

Rash

17.6

0.9

24.0

2.2

Dysgeusia

17.6

NA

14.2

NA

Upper respiratory tract infection

17.2

0

15.1

0

Malaise

15.4

0.9

8.9

0.4

Abbreviations: ALT = alanine aminotransferase; AST = aspartate aminotransferase; CTCAE = Common Terminology Criteria for Adverse Events; NA = not applicable (grade ≥3 alopecia and dysgeusia do not exist in CTCAE); TEAE = treatment-emergent adverse events.

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

2Data 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

OS = overall survival

PFS = progression-free survival

PS = performance status

Fecha de la última revisión: 2019 M10 24


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