Cyramza ® (ramucirumab)

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Cyramza® (ramucirumab): Effektivitet och säkerhet enligt ålder i REACH-2

Inga kliniskt relevanta skillnader i biverkningsprofil eller effektivitet sågs mellan behandlingsarmarna hos patienter <65 år och patienter ≥65 år.

Study Design

A global, randomized, double-blind, placebo-controlled study compared ramucirumab plus BSC and placebo plus BSC in patients with advanced HCC and elevated baseline AFP following first-line sorafenib.1

Patients were stratified by

  • geographic region (Americas, Europe, Israel, and Australia vs Asia [except Japan] vs Japan)

  • baseline ECOG PS (0 vs 1), and

  • macrovascular invasion (yes vs no).1

Patients were randomly assigned (2:1) to receive ramucirumab 8 mg/kg plus BSC (n=197) or placebo plus BSC (n=95) every 14 days until disease progression or unacceptable toxicity, or until discontinuation criteria were met.1 

Enrollment According to Age

In the REACH-2 study, the median patient age in both study arms was 64. Additional details on patient age are summarized in Table 1.

Table 1. Age Groups Represented in REACH-22


Ramucirumab + BSC
(n=197) 

Placebo + BSC
(n=95)

Total
(n=292)

Median age, years (range)

64 (30-88)

64 (26-85)

64 (26-88)

Age group, n (%)

Age <65 years

102 (51.8)

49 (51.6)

151 (51.7)

Age ≥65 years

95 (48.2)

46 (48.4)

141 (48.3)

Age 65 to <75 years

58 (29.4)

35 (36.8)

93 (31.8)

Age ≥75 years

37 (18.8)

11 (11.6)

48 (16.4)

Age 75 to <85 years

35 (17.8)

10 (10.5)

45 (15.4)

Age ≥85 years

2 (1.0)

1 (1.1)

3 (1.0)

Abbreviation: BSC = best supportive care. 

Efficacy

Efficacy results according to age are summarized in Table 2.

Table 2. Efficacy Results According to Age2


RAM + BSC
(n=102)

PBO + BSC
(n=49)

RAM + BSC
(n=95)

PBO + BSC
(n=46)

Age <65 years

Age ≥65 years

Median OSa, mo (95% CI)

8.74 (6.57-10.97)

9.0 (5.36-10.68)

7.98 (6.08-11.63)

6.08 (4.63-8.80)

HRb (95% CI); p valuec

0.848 (0.568-1.267); p=NS

0.641 (0.429-0.957); p=.0287

Interaction p valued

p=NS 

Median PFSa, mo (95% CI)

2.83 (2.17-3.75)

1.51 (1.41-2.69)

3.68 (2.76-5.13)

1.64 (1.45-2.83)

HRb (95% CI); p valuec

0.465 (0.316-0.686); p<.0001 

0.467 (0.316-0.688); p<.0001

Interaction p valued

p=NS 

ORR, n (%)

3 (2.9) 

1 (2.0)

6 (6.3) 

0

DCR, n (%)

57 (55.9) 

18 (36.7)

61 (64.2) 

19 (41.3)

Abbreviations: BSC = best supportive care; DCR = disease control rate; HR = hazard ratio; NS = not significant; ORR = overall response rate; OS = overall survival; PBO = placebo; PFS = progression-free survival; RAM = ramucirumab.

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

No clinically relevant differences were seen in terms of TEAE profile or differences between treatment arms in patients younger than 65 years of age and patients 65 years of age or older.2 Any grade TEAEs that occurred in at least 20% of patients in the ramucirumab arm (summarized by age) are summarized in Table 3.

Table 3. Any Grade TEAEs in ≥20% of Patients who Received Ramucirumab Plus BSC2 

MedDRA Preferred Term

RAM + BSC
(n=102) 

PBO + BSC
(n=49)

RAM + BSC
(n=95)

PBO + BSC
(n=46)

Age <65 years 

Age ≥65 years 

Abdominal pain 

23.5 

14.3 

15.8 

10.9

Fatigue 

22.5 

14.3 

32.6 

19.6

Decreased appetite 

20.6 

14.3 

26.3 

26.1

Headache 

20.6 

4.1 

7.4 

6.5

Hypertension 

20.6 

10.2 

28.4 

15.2

Proteinuria 

18.6 

2.0

22.1

6.5

Peripheral edema 

17.6 

8.2

33.7 

19.6

Ascites 

14.7 

10.2

21.1

4.3

Abbreviations: BSC = best supportive care; MedDRA = Medical Dictionary of Regulatory Activities; PBO = placebo; RAM = ramucirumab; TEAE = treatment-emergent adverse event.

References

1. Zhu AX, Kang YK, Yen CJ, et al. REACH-2: A randomized, double-blind, placebo-controlled phase 3 study of ramucirumab versus placebo as second-line treatment in patients with advanced hepatocellular carcinoma (HCC) and elevated baseline alpha-fetoprotein (AFP) following first-line sorafenib. Presented as an oral presentation at: 54th Annual Meeting of the American Society of Clinical Oncology (ASCO); June 1-5, 2018; Chicago, IL. Abstract #4003. https://meetinglibrary.asco.org/record/159169/abstract

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

Glossary

AFP = alpha-fetoprotein

BSC = best supportive care

ECOG = Eastern Cooperative Oncology Group

HCC = hepatocellular carcinoma

PS = performance status

TEAE = treatment-emergent adverse event

Datum fӧr senaste ӧversyn 2018 M07 01


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