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. 2013 Jul;6(5):275–286.

Table 1.

Targeted Agents Approved for RCC and Pivotal Phase 3 Clinical Trials

Drug, route of administration, approval date RCC indication Design of pivotal trial PFs in the overall population of pivotal trial
Sorafenib, oral11 December 20, 2005 Advanced RCC TARGET: randomized, double-blind study of sorafenib (n = 451) vs placebo (n = 452) in patients treated with 1 previous systemic therapy (primarily cytokines)18

  • Median, 5.5 mo with sorafenib vs 2.8 mo with placebo

  • HR, 0.44 (95% CI, 0.35–0.55; P <.001)
Sunitinib, oral12 February 2, 2007 Advanced RCC Randomized, open-label study of sunitinib (n = 375) vs IFN-α (n = 375) in treatment-naive patients19

  • Median, 11 mo with sunitinib vs 5 mo with IFN-α

  • HR, 0.539 (95% CI, 0.4510.643; P <.001)
Temsirolimus, IV13 May 30, 2007 Advanced RCC ARCC: randomized, open-label study of temsirolimus (n = 209) vs IFN-α (n = 207) vs temsirolimus + IFN-α (n = 210) in treatment-naive patients with ≥3 of 6 predictors of short survival20

  • Median, 3.8 mo with temsirolimus vs 1.9 mo with temsirolimus + IFN-α vs 3.7 mo with temsirolimus + IFN-α

  • HR, not available
Everolimus, oral14 March 30, 2009 RCC therapy after failure of treatment with sunitinib or sorafenib RECORD-1: randomized, double-blind study of everolimus (n = 277) vs placebo (n = 139) in patients previously treated with sunitinib and/or sorafenib21

  • Median, 4.9 mo with everolimus vs 1.9 mo with placebo

  • HR, 0.33 (95% CI, 0.25–0.43; P <.001)
Bevacizumab, IV, plus IFN-α, SC15 August 3, 2009 Metastatic RCC with IFN-α AVOREN: randomized, double-blind study of bevacizumab + IFN-α (n = 327) vs placebo + IFN-α (n = 322) in treatment-naive patients22

  • Median, 10.2 mo with bevacizumab + IFN-α vs 5.4 mo with placebo + IFN-α

  • HR, 0.63 (95% CI, 0.52–0.75; P = .001)
CALGB 90206: randomized, open-label study of bevacizumab + IFN-α (n = 369) vs IFN-α (n = 363) in treatment-naive patients23

  • Median, 8.5 mo with bevacizumab + IFN-α vs 5.2 mo with IFN-α

  • HR, 0.72 (95% CI, 0.61–0.83; P <.001)
Pazopanib, oral16 October 19, 2009 Adults for first-line treatment of advanced RCC and for patients who have received previous cytokine therapy for advanced disease Randomized, double-blind study of pazopanib (n = 290) vs placebo (n = 145) in treatment-naive and cytokine-pretreated patients24

  • Median, 9.2 mo with pazopanib vs 4.2 mo with placebo

  • HR, 0.46 (95% CI, 0.34–0.62; P <.001)
Axitinib, oral17 January 27, 2012 Treatment of RCC after failure of 1 previous systemic therapy AXIS: randomized, open-label study of axitinib (n = 361) vs sorafenib (n = 362) in patients treated with 1 previous systemic therapy25

  • Median, 6.7 mo with axitinib vs 4.7 mo with sorafenib

  • HR, 0.665 (95% CI, 0.5440.812; P <.001)

CI indicates confidence interval; HR, hazard ratio; IFN, interferon; IV, intravenous; PFS, progression-free survival; RCC, renal cell carcinoma; SC, subcutaneous.