Cyramza ® (ramucirumab)

För fullständig produktresumé för Cyramza® se FASS.

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Cyramza® (ramucirumab): Refraktoriska NSCLC Patienter

Refraktoriska patienter som fick Cyramza (ramucirumab) och docetaxel för NSCLC upplevde signifikant längre progressionsfri överlevnad och total överlevnad än patienter som fick placebo.



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

Refractory Patient Analysis

Patients with a best response of progressive disease to first-line therapy were considered primary platinum refractory. This patient population had a poorer prognosis compared with patients who did not meet this criterion (docetaxel plus placebo arm: median OS 6.3 months in refractory patients vs 10.3 months in non-refractory patients).3 

A total of 29% (n=360) of patients enrolled in the REVEL study were considered primary platinum refractory:

  • ramucirumab plus docetaxel, n=178

  • placebo plus docetaxel, n=182.3

Baseline characteristics in this patient population were balanced between the 2 treatment arms.3

Efficacy Results

An exploratory analysis of refractory patients found that median OS, PFS, and ORR were greater in patients who received ramucirumab and docetaxel compared with patients who received docetaxel and placebo.3 These results are summarized in Table 1. Efficacy in Patients in the REVEL Study With Platinum Refractory Disease.

Table 1. Efficacy in Patients in the REVEL Study With Platinum Refractory Disease3

Outcome Measure

Ramucirumab + Docetaxel (n=178)

Placebo + Docetaxel (n=182)

Median OS, months (95% CI)

8.3 (6.6-9.8)

6.3 (5.1-8.0)

HRa (95% CI)

0.86 (0.68-1.08)

Median PFS, months (95% CI)

4.0 (2.9-4.4)

2.5 (1.6-2.8)

HRa (95% CI)

0.71 (0.57-0.88)

ORR (CR + PR), %

22.5

12.6

Abbreviations: CR = complete response; HR = hazard ratio; ORR = objective response rate; OS = overall survival; PFS = progression-free survival; PR = partial response. 

a Unstratified HR.

Safety Results

The incidence of grade ≥3 TEAEs in refractory patients was similar between those who received ramucirumab and docetaxel (74%) and those who received docetaxel and placebo (70%). The incidence of death from TEAEs was 6% in the ramucirumab and docetaxel arm and 9% in the docetaxel and placebo arm.3

References

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. Reck M, Paz-Ares L, Bidoli P, et al. Outcomes in patients with aggressive or refractory disease from REVEL: A randomized phase III study of docetaxel with ramucirumab or placebo for second-line treatment of stage IV non-small-cell lung cancer. Lung Cancer. 2017;112:181-187. https://doi.org/10.1016/j.lungcan.2017.07.038.

Glossary

ECOG = Eastern Cooperative Oncology Group

NSCLC = non-small cell lung cancer

ORR = objective response rate

OS = overall survival

PFS = progression-free survival

PS = performance status

TEAE = treatment-emergent adverse event

Datum fӧr senaste ӧversyn 2019 M01 11


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