Cyramza ® (ramucirumab)

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Cyramza® (ramucirumab): REACH och REACH2 Combinerad Analys

Analys av effektivitet och säkerhet för ramucirumab hos patienter med HCC har genomförts genom att samla in data från REACH och REACH-2, respektive.

Combined Analysis of REACH and REACH-2

REACH-2 and REACH were both global, randomized, placebo-controlled phase 3 trials with similar study eligibility, protocol procedures, treatment regimen, and study endpoints. In both studies, patients were randomized to receive either ramucirumab plus BSC or placebo plus BSC.1

Efficacy Results

Overall survival among patients in REACH (baseline AFP ≥400 ng/mL), REACH-2, and in the pooled analysis (REACH [baseline AFP ≥400 ng/mL] + REACH-2) are summarized in Table 1. Additional efficacy results among patients in the pooled analysis are summarized in Table 2.

Table 1. Overall Survival Results1

Endpoint

RAM + BSC
(n=119)

PBO+ BSC
(n=131)

RAM + BSC
(n=197)

PBO + BSC
(n=95)

RAM + BSC
(n=316)

PBO + BSC
(n=226)

REACH (Baseline AFP ≥400 ng/mL)a  

REACH-2a  

Pooled (REACH [Baseline AFP ≥400 ng/mL] + REACH-2)  

Median OS, months

7.8 

4.2 

8.5

7.3

8.1 

5.0

HR (95% CI); p value

0.674 (0.508-0.895); p=.0059

0.710 (0.531-0.949); p=.0199

0.694 (0.571-0.842); p=.0002

Abbreviations: AFP = alpha fetoprotein; BSC = best supportive care; HR = hazard ratio; OS = overall survival; PBO = placebo; RAM = ramucirumab.

a Impact of post-discontinuation therapy was minimal; censoring at time of initiation of postdiscontinuation therapy demonstrated impact on median OS was <1 month in either arm.

Table 2. Efficacy Results Among Patients in the Pooled Analysis (REACH [Baseline AFP ≥400 ng/mL] + REACH-2)1

Efficacy Endpoints 

RAM + BSC
(n=316) 

PBO + BSC
(n=226)

Median PFS, months

2.8 

1.5

HR (95% CI); p value

0.572 (0.472-0.694); p<.0001

ORRa (95% CI), %

5.4 (2.9-7.9) 

0.9 (0-2.1)

P value

p=.0064

DCRa (95% CI), %

56.3 (50.9-61.8)

37.2 (30.9-43.5)

P value

p<.0001

Abbreviations: AFP = alpha fetoprotein; BSC = best supportive care; DCR = disease control rate; HR = hazard ratio; ORR = objective response rate; PBO = placebo; PFS = progression-free survival; RAM = ramucirumab; RECIST = Response Evaluation Criteria in Solid Tumors; v = version.

a Tumor assessment based on RECIST, v1.1.

Safety Results

Adverse events of special interest from the pooled analysis (REACH [baseline AFP ≥400 ng/mL] + REACH-2) analysis are presented in Table 3.

Table 3. Adverse Events of Special Interest Among Patients in the Pooled Analysis (REACH [Baseline AFP ≥400 ng/mL] + REACH-2)1

AESI, % of patients

Any Grade

Grade ≥3

Any Grade

Grade ≥3

RAM + BSC
(n=316)

PBO + BSC
(n=223)

Liver injury/liver failure 

44.3

19.9

39.0

26.5

Ascitesa

20.9

4.7

14.8

4.0

Hepatic encephalopathya

4.1

2.8

0.9

0.4

Bleeding/hemorrhage events

25.0

4.7

17.9

6.7

GI hemorrhage events

7.6

3.5

8.5

5.4

Epistaxisa

12.3

0.3

5.4

0

Hypertension

21.5

12.7

9.0

3.6

Proteinuria

18.7

1.3

5.4

0

Infusion-related reactionsb

9.2

0.3

3.1

0

Arterial TE

1.6

0.9

1.3

0.9

Venous TE

0.9

0.3

2.7

2.2

GI perforation

0.6

0.6

0.9

0.9

Congestive heart failure

0.3

0.3

0.4

0.4

Fistula

0.3 

0

0

0

Abbreviations: AESI = adverse event of special interest; AFP = alpha fetoprotein; BSC = best supportive care; GI = gastrointestinal; PBO = placebo; RAM = ramucirumab; TE = thromboembolic.

a Preferred term.

b Occurred within 24 hours of infusion.

References

1. Zhu AX, Finn RS, Galle PR, et al. Ramucirumab as second-line treatment in patients with advanced hepatocellular carcinoma (HCC) and elevated alpha-fetoprotein (AFP) following first-line sorafenib: pooled efficacy and safety across two global randomized phase 3 studies (REACH-2 and REACH). Talk presented at: 20th Annual Meeting of the European Society for Medical Oncology (ESMO) World Congress on Gastrointestinal Cancer; June 20-23, 2018; Barcelona, Spain. Abstract #LBA-001. https://www.postersessiononline.eu/173580348_eu/congresos/20wcgic/aula/-LB_1_20wcgic.pdf

Glossary

AFP = alpha-fetoprotein

BSC = best supportive care

HCC = hepatocellular carcinoma

Datum fӧr senaste ӧversyn 2019 M01 22


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