Therapeutic efficacy of Axitinib

The safety and efficacy of INLYTA were evaluated 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.

FDA，2012.01