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Cyramza ® (ramucirumab)
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Information from Summary of Product Characteristics
Cyramza in combination with docetaxel is indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer with disease progression after platinum-based chemotherapy.1
Study Design
The REVEL trial was a phase 3, multicenter, randomized, double-blind, placebo-controlled trial in patients with pathologically confirmed, squamous or nonsquamous, stage IV NSCLC with disease progression during or after 1 prior platinum-based chemotherapy. Prior treatment with bevacizumab and prior maintenance therapy were allowed and all patients had an ECOG PS of 0 or 1. Patients were randomly assigned in a 1:1 ratio (stratified by sex, region, PS, and previous maintenance therapy) to receive treatment with ramucirumab (10 mg/kg every 3 weeks) plus docetaxel (75 mg/m2 every 3 weeks) (n=628) or placebo plus docetaxel (75 mg/m2 every 3 weeks) (n=625) until disease progression, unacceptable toxicity, withdrawal, or death.2
In the REVEL study, 24% of patients in each arm received prior taxane therapy (n=153 in the ramucirumab plus docetaxel arm and n=149 in the placebo plus docetaxel arm).2
Protocol Requirements Related to Prior Taxane Therapy
Patients were excluded from the REVEL trial if they had received prior therapy with docetaxel.2
Efficacy
Table 1 describes the OS and PFS results according to prior taxane therapy in the REVEL study.
Table 1. Overall and Progression-Free Survival Results According to Prior Taxane Therapy3
|
RAM
+ DOC |
PBO
+ DOC |
RAM
+ DOC |
PBO
+ DOC |
Prior Taxane |
No Prior Taxane |
|||
Median OS, mo (95% CI) |
10.81 (8.90-12.42) |
10.35 (7.82-12.12) |
10.32 (9.30-11.27) |
9.03 (8.05-9.79) |
HR (95% CI) |
0.81 (0.62-1.07); p=NS |
0.87 (0.75-1.01); p=NS |
||
Interaction p value |
NS |
|||
Median PFS, mo (95% CI) |
4.44 (3.61-5.52) |
3.61 (2.76-4.30) |
4.50 (4.17-5.39) |
2.92 (2.76-3.81) |
HR (95% CI) |
0.90 (0.71-1.15); p=NS |
0.74 (0.64-0.84); p<.001 |
||
Interaction p value |
NS |
Abbreviations: DOC = docetaxel; HR = hazard ratio; NS = not significant; OS = overall survival; PBO = placebo; PFS = progression-free survival; RAM = ramucirumab.
Safety
Table 2 describes any grade TEAEs that occurred in at least 20% of patients in the ramucirumab plus docetaxel arm (summarized according to prior taxane). presents grade ≥3 TEAEs that occurred in at least 10% of patients in the ramucirumab plus docetaxel arm (summarized according to prior taxane).
Table 2. Any Grade Treatment-Emergent Adverse Events in ≥20% of Patients Who Received Ramucirumab Plus Docetaxel According to Prior Taxane3
Any Grade TEAE, Regardless of Causalitya |
RAM
+ DOC |
PBO
+ DOC |
RAM
+ DOC |
PBO
+ DOC |
Prior Taxane |
No Prior Taxane |
|||
Fatigue |
44.2 |
36.7 |
46.7 |
43.3 |
Neutropenia |
41.6 |
40.1 |
38.1 |
31.0 |
Nausea |
29.9 |
29.9 |
26.0 |
26.8 |
Diarrhea |
29.2 |
29.9 |
32.6 |
27.0 |
Decreased appetite |
27.9 |
27.9 |
29.4 |
24.0 |
Dyspnea |
22.7 |
25.2 |
21.8 |
23.8 |
Anemia |
21.4 |
28.6 |
20.7 |
27.4 |
Cough |
17.5 |
20.4 |
22.4 |
20.8 |
Alopecia |
14.9 |
14.3 |
29.4 |
28.7 |
Stomatitis |
18.8 |
6.8 |
24.7 |
14.9 |
Abbreviations: DOC = docetaxel; MedDRA = Medical Dictionary of Regulatory Activities; PBO = placebo; RAM = ramucirumab; TEAE = treatment-emergent adverse event.
Table 3. Grade ≥3 Treatment-Emergent Adverse Events in ≥20% of Patients who Received Ramucirumab Plus Docetaxel According to Prior Taxane3
Grade ≥3 TEAE, Regardless of Causalitya |
RAM
+ DOC |
PBO
+ DOC |
RAM
+ DOC |
PBO
+ DOC |
Prior Taxane |
No Prior Taxane |
|||
Fatigue |
13.6 |
6.1 |
10.6 |
8.7 |
Neutropenia |
36.4 |
29.9 |
34.5 |
27.4 |
Neutrophil count decreased |
15.6 |
11.6 |
15.4 |
13.6 |
Febrile neutropenia |
13.6 |
12.9 |
16.7 |
9.1 |
Abbreviations: DOC = docetaxel; MedDRA = Medical Dictionary of Regulatory Activities; PBO = placebo; RAM = ramucirumab; TEAE = treatment-emergent adverse event.
1. Cyramza [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.
2. Garon EB, Ciuleanu TE, Arrieta O, et al. Ramucirumab plus docetaxel versus placebo plus docetaxel for second-line treatment of stage IV non-small-cell lung cancer after disease progression on platinum-based therapy (REVEL): a multicentre, double-blind, randomised phase 3 trial. Lancet. 2014;384(9944):665-673. http://dx.doi.org/10.1016/S0140-6736(14)60845-X
3. Data on file, Eli Lilly and Company and/or one of its subsidiaries.
Glossary
ECOG = Eastern Cooperative Oncology Group
NSCLC = non-small cell lung cancer
OS = overall survival
PFS = progression-free survival
PS = performance status
TEAE = treatment-emergent adverse event
Datum fӧr senaste ӧversyn 2019 M12 06