icacy of INLYTA were eva luated in a randomized, open-label, multicenter Phase 3 study. Patients (N=723) with advanced RCC whose disease had progressed on or after treatment with 1 prior systemic therapy, including sunitinib-, bevacizumab-, 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
* Time from randomization to progression or death due to any cause, whichever occurs first. † Assessed by independent radiology review according to RECIST. ‡ One-sided p-value from a log-rank test of treatment stratified by ECOG performance status and prior therapy (comparison is considered statistically significant if the one-sided p-value is <0.023). § Risk ratio is used for ORR. A risk ratio >1 indicated a higher likelihood of responding in the axitinib arm; a risk ratio <1 indicated a higher likelihood of responding in the sorafenib arm. ¶ P-value not included since it was not adjusted for multiple testing.
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
N=125
Median, months (95% CI)
12.1 (10.1, 13.9)
6.5 (6.3, 8.3)
0.46 (0.32, 0.68)
Figure 2. Kaplan-Meier Curve for Progression Free Survival by Independent Assessment (Intent-to-Treat Population)
16 HOW SUPPLIED/STORAGE AND HANDLING
INLYTA tablets are supplied as follows:
1 mg tablets are red film-coated, oval tablets debossed with "Pfizer" on one side and "1 XNB" on the other; available in bottle
