Inyta first line for renal cell carcinoma – pro

In the AXIS trial, axitinib prolonged progression-free survival (PFS) vs sorafenib in patients with advanced renal cell carcinoma (RCC) previously treated with sunitinib or cytokines, based on which axitinib was approved in second line. Clinical benefit of axitinib as a first line agent to treat patients with metastatic renal cell carcinoma (mRCC), or locally advanced renal cell carcinoma (RCC) has been demonstrated in phase II trials and European guidelines in 2012 speculated that this drug soon might show evidence of efficacy in first line therapy. However, the the AGILE clinical trial compared axitinib to another drug, sorafenib, which has broader specificity for its kinase targets. The AGILE trial failed to meet its primary objective of improving progression-free survival (PFS). However, it did did demonstrate clinical activity and an acceptable safety profile.

3. If yes to question 2, please provide duration of therapy (typical duration 24 months).
24 months

B. Escudier et al, Renal cell carcinoma: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol (2012) 23 (suppl 7): vii65-vii71.

Hutson T et al, Axitinib versus sorafenib as first-line therapy in patients with metastatic renal-cell carcinoma: a randomised open-label phase 3 trial.
Lancet Oncol. 2013 Dec;14(13):1287-94.

Ian D. Davis, TAxitinib in renal cell carcinoma: now what do we do?ranslational Cnaner Reserch, Vol 3, No 6 (December 2014)
Isabella Testa, Roberto Iacovelli, Pamela Biondani, Enrico Garanzini, Filippo De Braud, and Giuseppe ProcopioT, argeted treatments in advanced renal cell carcinoma: focus on axitinib. Pharmgenomics Pers Med. 2014; 7: 107–116.

Ana M. Molina and Robert J. Motzer, Clinical Practice Guidelines for the Treatment of Metastatic Renal Cell Carcinoma: Today and Tomorrow. Oncologist. 2011 Feb; 16(Suppl 2): 45–50.

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