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Aveo Oncology remains optimistic with tivozanib

  • Final results from the TIVO-1 extension study, known as Study 902, assessing Aveo Oncology's (AVEO +19.4%) lead product candidate, tivozanib, as second-line treatment in patients with advanced renal cell carcinoma (RCC) that progressed after treatment with sorafenib (branded as Nexavar and co-promoted by Onyx Pharmaceuticals (AMGN +0.3%) and Bayer (OTCPK:BAYRY -0.3%)) show a median progression-free survival of 11.0 months and median overall survival of 21.6 months (statistical significance not disclosed). The data, along with results from the Phase 3 TIVO-1 trial, will be presented at the American Society of Clinical Oncology Annual Meeting in Chicago on the afternoon of June 1.
  • The company has had a bit of a rough time time finding a niche for tivozanib. In January 2014, it axed a Phase 2 trial in breast cancer due to poor enrollment. Its collaboration with Astellas Pharma in colon cancer ended a month later after a mid-stage trial failed. Both followed the FDA's rejection of its New Drug Application (NDA) for kidney cancer due to inconsistent study results.
  • The company is undeterred, though. It sought FDA guidance about a new 314-subject Phase 3 trial assessing tivozanib as third-line treatment in advanced RCC. The regulator responded that the data "may support" the indication. As always, it will be review issue.

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