Positive preliminary results from tivozanib-paclitaxel combination Phase 1b trial in metastatic breast cancer

AVEO Pharmaceuticals, Inc. (NASDAQ: AVEO), a biopharmaceutical company focused on discovering, developing and commercializing cancer therapeutics, today announced preliminary results from an ongoing Phase 1b clinical trial evaluating the company's lead product candidate, tivozanib, a highly potent and selective inhibitor of VEGF receptors 1, 2, and 3, in combination with paclitaxel (Taxol^®), a standard chemotherapy regimen, in patients with metastatic breast cancer. The combination was considered safe at the full recommended tivozanib dose (1.5 mg/day) and standard paclitaxel dose, and demonstrated encouraging clinical activity in patients with metastatic breast cancer. These data were presented in a poster session today at the 33^rd Annual San Antonio Breast Cancer Symposium in San Antonio, Texas by Erica L. Mayer, M.D., M.P.H., medical oncologist, Breast Oncology Center at the Dana-Farber Cancer Institute and lead investigator in the study.

"In this Phase 1 study, the combination of tivozanib and weekly paclitaxel was tolerable for patients and demonstrated notable activity," said Dr. Mayer. "Further study of tivozanib in combination with anti-cancer agents such as paclitaxel is warranted in breast cancer."

The Phase 1b open-label, dose-escalation study assessed once-daily, oral tivozanib (sequential cohorts of 0.5, 1.0, and 1.5 mg/day for three weeks on, one week off) and paclitaxel (once-weekly intravenously for three weeks on, one week off) in 18 patients with metastatic breast cancer, all of whom had prior taxane therapy and most of whom had prior bevacizumab therapy. With a mean duration of treatment of 22.2 weeks, key findings included:

• Confirmed partial responses were observed in five of the 18 patients, as evaluated by standard Response Evaluation Criteria in Solid Tumors (RECIST)
• Objective response rate (ORR) was 28 percent and 44 percent of patients achieved disease control
• Median progression-free survival (PFS) was 10.4 months
• Drug-related adverse events were not observed in association with the combination that were more frequent or severe than those observed in previous studies with tivozanib or paclitaxel alone
• There were no unexpected drug-related serious adverse events in the study

"These data in patients with metastatic breast cancer, along with the data we anticipate generating from the recently initiated Phase 1b clinical trial evaluating tivozanib in combination with oral capecitabine, help to inform our strategic clinical development program for tivozanib," said William Slichenmyer, M.D., Sc.M., chief medical officer at AVEO. "We are encouraged by these first results in breast cancer as we evaluate opportunities to pursue additional indications outside of our potential lead indication for tivozanib in the treatment of advanced renal cell cancer."