Aveo slips on tivozanib update in colorectal cancer

Aveo Pharmaceuticals Inc. (NASDAQ:AVEO) said a planned interim analysis of the Phase II BATON-CRC trial showed first-line treatment with tivozanib plus chemotherapy is unlikely to meet the primary endpoint of improving progression-free survival (PFS) vs. Avastin bevacizumab plus chemotherapy to treat metastatic colorectal cancer (mCRC). The news sent Aveo shares sliding $0.17 to $1.71 on Friday. The open-label, international trial was enrolling mCRC patients to receive mFOLFOX6 chemotherapy (5-fluorouracil (5-FU), folinic acid and oxaliplatin) in combination with tivozanib or Avastin from Roche (SIX:ROG; OTCQX:RHHBY) and its Genentech Inc. unit. Aveo declined to disclose detailed data but said it is in discussions with partner Astellas Pharma Inc. (Tokyo:4503) regarding next steps.

In May, Aveo disclosed in an SEC filing that Astellas no longer plans to submit an MAA to EMA for tivozanib to treat advanced renal cell carcinoma (RCC) and does not intend to fund future trials in RCC. In June, Aveo received a complete response letter from FDA for an NDA for tivozanib to treat advanced RCC. That same month, the company said it would reduce headcount by 62% to about 86 to focus resources on clinical development of tivozanib for colorectal and breast cancer (see BioCentury Extra, June 10). ...