ety and efficacy of axitinib were eva luated in a randomised, open-label, multicenter Phase 3 study. Patients (N=723) with advanced RCC whose disease had progressed on or after treatment with one prior systemic therapy, including sunitinib-, bevacizumab-, temsirolimus-, or cytokine-containing regimens were randomised (1:1) to receive axitinib (n=361) or sorafenib (n=362). The primary endpoint, progression-free survival (PFS), was assessed using a blinded independent central review. Secondary endpoints included objective response rate (ORR) and overall survival (OS).
Of the patients enrolled in this study, 389 patients (53.8%) had received one prior sunitinib-based therapy, 251 patients (34.7%) had received one prior cytokine-based therapy (interleukin-2 or interferon-alpha), 59 patients (8.2%) had received one prior bevacizumab-based therapy, and 24 patients (3.3%) had received one prior temsirolimus-based therapy. The baseline demographic and disease characteristics were similar between the axitinib and sorafenib groups with regard to age, gender, race, Eastern Cooperative Oncology Group (ECOG) performance status, geographic region, and prior treatment.
In the overall patient population and the two main subgroups (prior sunitinib treatment and prior cytokine treatment), there was a statistically significant advantage for axitinib over sorafenib for the primary endpoint of PFS (see Table 2 and Figures 1, 2 and 3). The magnitude of median PFS effect was different in the subgroups by prior therapy. Two of the subgroups were too small to give reliable results (prior temsirolimus treatment or prior bevacizumab treatment). There were no statistically significant differences between the arms in OS in the overall population or in the subgroups by prior therapy.
Table 2. Effi
|
Endpoint / Study Population
|
Axitinib
|
Sorafenib
|
HR (95% CI)
|
p-value
|
|
Overall ITT
|
N = 361
|
N = 362
|
|
|
|
Median PFS a,b in months (95% CI)
|
6.8 (6.4, 8.3)
|
4.7 (4.6, 6.3)
|
0.67 (0.56, 0.81)
|
< 0.0001c
|
|
Median OS d in months (95% CI)
|
20.1 (16.7, 23.4)
|
19.2 (17.5, 22.3)
|
0.97 (0.80, 1.17)
|
NS
|
|
ORR b,e % (95% CI)
|
19.4 (15.4, 23.9)
|
9.4 (6.6, 12.9)
|
2.06f (1.41, 3.00)
|
0.0001g
|
|
Prior sunitinib treatment
|
N = 194
|
N = 195
|
|
|
|
Median PFS a,b in months (95% CI)
|
4.8 (4.5, 6.5)
|
3.4 (2.8, 4.7)
|
0.74 (0.58, 0.94)
|
0.0063h
|
|
Median OS d in months (95% CI)
|
15.2 (12.8, 18.3)
|
16.5 (13.7, 19.2)
|
1.00 (0.78, 1.27)
|
NS
|
|
|
|
