zumab-, temsirolimus-, or cytokine-containing regimens were randomized (1:1) to receive Inlyta (N=361) or sorafenib (N=362). Progression-free survival (PFS) was assessed by a blinded independent central review committee. Other endpoints included objective response rate (ORR) and overall survival (OS).
Of the patients enrolled in this study, 389 patients (54%) had received 1 prior sunitinib-based therapy, 251 patients (35%) had received 1 prior cytokine-based therapy (interleukin-2 or interferon-alfa), 59 patients (8%) had received 1 prior bevacizumab-based therapy, and 24 patients (3%) had received 1 prior temsirolimus-based therapy. The baseline demographic and disease characteristics were similar between the Inlyta and sorafenib groups with regard to age (median 61 years), gender (72% male), race (75% white, 21% Asian), Eastern Cooperative Oncology Group (ECOG) performance status (55% 0, 45% 1), and histology (99% clear cell).
There was a statistically significant advantage for Inlyta over sorafenib for the endpoint of PFS (see Table 3 and Figure 2). There was no statistically significant difference between the arms in OS.
Table 3. Efficacy Results
|
Endpoint/Study Population |
Inlyta |
Sorafenib |
HR (95% CI) |
P-value |
|
CI: Confidence interval; HR: Hazard ratio (Inlyta/sorafenib); ITT: Intent to treat; ORR: Objective response rate; NS: Not significant; OS: Overall survival; PFS: Progression-free survival |
|
|
|
Overall ITT |
N= 361 |
N = 362 |
|
|
|
Median PFS*,† in months (95% CI) |
6.7 (6.3, 8.6) |
4.7 (4.6, 5.6) |
0.67 (0.54, 0.81) |
<0.0001‡ |
|
Median OS in months (95% CI) |
20.1 (16.7, 23.4) |
19.2 (17.5, 22.3) |
0.97 (0.80, 1.17) |
NS |
|
ORR % (95% CI) |
19.4 (15.4, 23.9) |
9.4 (6.6, 12.9) |
2.06(1.41, 3.00) |
-¶ |
|
PFS by prior treatment |
|
|
|
|
|
Sunitinib-refractory subgroup |
N=194 |
N=195 |
|
|
|
Median, months (95% CI) |
4.8 (4.5, 6.4) |
3.4 (2.8, 4.7) |
0.74 (0.57, 0.96) |
-¶ |
|
Cytokine-refractory subgroup |
N=126 |
|
