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Efficacy & Clinical DataINLYTA® is a cornerstone therapy for advanced RCC that continues to deliver efficacy outcomes for patients1–6 Experience

Experience with INLYTA® extends beyond 10 years.1

  • Cumulatively, close to 133,417.48 patients have RCC have been treated with INLYTA (axitinib) worldwide since product launch.6
  • The efficacy and safety of INLYTA® is supported by a wealth of data from clinical trials and real-world studies1–5
*Internal calculations by Pfizer using IQVIA MIDAS Sales Data Q1 2012- Q4 2021 Sell-In/Sell-Out data.6  Implied patient number estimate = Days of treatment (DOT)/ (Pfizer defined duration of therapy* Compliance).AXIS Phase lll trial

INLYTA® delivered superior progression-free survival (PFS) and objective response rate (ORR) outcomes versus sorafenib in adult patients with advanced renal cell carcinoma after first-line sunitinib or a cytokine in a phase III second line setting.1,2

  • The safety and efficacy of Inlyta were evaluated in a randomised, open-label, multicentre Phase 3 study. 723 patients 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).1
Median PFS (ITT population) with INLYTA® vs. sorafenib1* 

Adapted from INLYTA® Summary of Product Characteristics.
*Scans assessed by blinded independent radiology review.1,2
Time from randomisation to progression or death due to any cause, whichever occurs first. Cutoff date: 03 June 2011

HeaderORR (ITT population) with INLYTA® vs. sorafenib1* 

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.
Data adapted from INLYTA® Summary of Product Characteristics.
*ORR is derived from complete and partial response as per RECIST.1,2
Data cutoff date: 31 August 2010

HeaderReal-world evidence

Real-world evidence supports clinical trial outcomes with INLYTA® in second line.1–5

Median PFS with INLYTA® second-line therapy in real-world studies3–5

Data adapted from Melichar B, et al. 2015. Matias M, et al. 2017. Facchini G, et al. 2019.
No cross trial comparisons may be made since trials were conducted using different methodologies and at different time points.

HeaderCzech clinical registry data3
  • A retrospective analysis of RenIS registry data assessing the efficacy and safety of INLYTA® as second-line therapy in 97 patients with mRCC following first-line treatment with sunitinib in real-world clinical practice
French real-world experience4
  • A prospective evaluation of the efficacy and safety of INLYTA® as second-line or further-line therapy in 106 patients with mRCC in a large comprehensive cancer centre
SAX Italian real-world trial5
  • An observational, retrospective study assessing the efficacy and safety of INLYTA® as second-line therapy in 148 patients with mRCC following first-line treatment with sunitinib
CI, confidence interval. HR, hazard ratio. ITT, intention to treat. mPFS, median progression-free survival. mRCC, metastatic renal cell carcinoma. ORR, objective response rate. PFS, progression-free survival. RCC, renal cell carcinoma. RECIST, Response Evaluation Criteria in Solid Tumours. TKI, tyrosine kinase inhibitor. VEGFR, vascular endothelial growth factor receptor. RR, Risk Ratio.ReferencesINLYTA® Summary of Product Characteristics.Rini BI, et al. Lancet 2011;378:1931–1939.Melichar B, et al. Efficacy and tolerability of axitinib in metastatic renal cell carcinoma (mRCC): comparison of Czech clinical registry and AXIS trial data. ECC. 25–29 September 2015. Vienna, Austria. Poster: 2615.
Matias M, et al. Eur J Cancer 2017;79:185–192.
Facchini G, et al. J Transl Med 2019;17:296.IQVIA MIDAS Sales Data Q1 2012- Q4 2021 Sell-In/Sell-Out data.
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