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Pfizer Announces Top-line Results From Phase 3 Trial Of INLYTA® (axitinib) In Treatment-Naïve Patients With Advanced Renal Cell Carcinoma

“We set a high bar in our INLYTA trials to understand how it compares to another VEGF-targeted therapy,” said Dr. Rothenberg. “Since approval, INLYTA has established its utility in the second-line setting where it is an important treatment option for many patients with advanced kidney cancer.”

Pfizer is also investigating axitinib in the AGILE 1046 study, a randomized Phase 2 clinical trial in treatment-naïve patients with advanced RCC. Blinded efficacy data from this ongoing study were presented at ASCO earlier this year. Axitinib is also being studied in a randomized Phase 2 clinical trial for the treatment of hepatocellular carcinoma (HCC), which is currently closed to enrollment. Additionally, under a collaborative development agreement between Pfizer and SFJ Pharma Ltd. II, SFJ is conducting a Phase 3 clinical trial in Asia studying axitinib for adjuvant treatment of patients at high risk of recurrent RCC following nephrectomy (kidney removal).

Healthcare professionals who are interested in learning more about Pfizer Oncology clinical trials that are open for enrollment can visit www.PfizerOncology.com/clinicaltrials. Patients with questions should contact their treating physician.

About INLYTA® (axitinib)

INLYTA is indicated for the treatment of advanced RCC after failure of one prior systemic therapy. INLYTA, a kinase inhibitor, is an oral therapy that is designed to inhibit tyrosine kinases, including vascular endothelial growth factor (VEGF) receptors 1, 2 and 3; these receptors can influence tumor growth, vascular angiogenesis and progression of cancer (the spread of tumors).

Important INLYTA® (axitinib) Safety Information

Hypertension including hypertensive crisis has been observed. Blood pressure should be well controlled prior to initiating INLYTA. Monitor for hypertension and treat as needed. For persistent hypertension, despite use of antihypertensive medications, reduce the dose. Discontinue INLYTA if hypertension is severe and persistent despite use of antihypertensive therapy and dose reduction of INLYTA, and discontinuation should be considered if there is evidence of hypertensive crisis.

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