For Patients

Who is AVEO?

AVEO is a biopharmaceutical company focused on discovering, developing and commercializing novel cancer therapeutics. Our product candidates are directed against important mechanisms, or targets, known or believed to be involved in cancer. Tivozanib, our lead product candidate, is a highly potent and selective oral inhibitor of the vascular endothelial growth factor, or VEGF, receptors 1, 2 and 3. Our clinical trials of tivozanib to date have demonstrated a favorable safety and efficacy profile for tivozanib.

 

Tivozanib - In Development for the Treatment of Cancers, Starting with Kidney Cancer

In February of 2010, AVEO initiated patient enrollment in our Phase 3 clinical trial of tivozanib in patients with advanced RCC, in which we plan to enroll 500 patients, called the TIVO-1 study.  TIVO-1 is a randomized, controlled clinical trial of tivozanib compared to Nexavar (sorafenib) in advanced clear cell RCC patients who have undergone a prior nephrectomy, and who have not received any prior VEGF-targeted therapy. Nexavar is an oral VEGF receptor inhibitor approved for the treatment of RCC. Progression-free survival is the primary endpoint in the TIVO-1 study. TIVO-1 is designed so that a difference in progression-free survival of three months or more between the treatment arms would be statistically significant. Inhibition of the VEGF pathway has demonstrated benefit for patients with a wide range of cancer types, including RCC, metastatic breast cancer, colorectal cancer, non-small cell lung cancer, liver cancer and brain cancer. 

 

TIVOZANIB - A Highly Potent and Selective VEGF Receptor Inhibitor

AVEO’s clinical trials of tivozanib to date have demonstrated a favorable safety and efficacy profile for tivozanib. We have completed a successful 272-patient phase 2 clinical trial of tivozanib in patients with advanced renal cell cancer, or RCC. In this trial, we measured, among other things, each patient’s progression-free survival, which refers to the period of time that began when a patient entered the clinical trial and ended when either the patient died or the patient’s cancer had grown by a specified percentage or spread to a new location in the body.  The overall median progression-free survival of patients in the phase 2 clinical trial was 11.8 months.  In a retrospective analysis of the subset of 176 patients in our phase 2 clinical trial who had the clear cell type of RCC and who had undergone a prior nephrectomy, both of which are inclusion criteria for our phase 3 clinical trial of tivozanib, the median progression-free survival was 14.8 months.  The incidence of side effects in the trial, such as diarrhea, fatigue, rash, mucositis, stomatitis and hand-foot syndrome, which are commonly associated with other VEGF receptor inhibitors, was notably low, with moderate to severe episodes of these side effects occurring in fewer than two percent of treated patients. 

Due to tivozanib’s potency and specificity, we believe that it may enable optimal inhibition of the VEGF pathway, while minimizing side effects associated with inhibition of other pathways, referred to as off-target toxicities. We believe this favorable efficacy and safety profile may allow tivozanib to be successfully used as a monotherapy. It may also allow tivozanib to be more readily combined with standard chemotherapy as well as other targeted therapies, potentially increasing the breadth of its clinical utility.

Tivozanib Clinical Trials

In addition to our ongoing Phase 3 clinical trial of once-daily, oral tivozanib in patients with advanced RCC, we are currently conducting multiple clinical trials of tivozanib including:

• a phase 1b clinical trial in combination with Torisel (temsirolimus), an approved inhibitor of the receptor known as mammalian target of rapamycin, or mTOR, in patients with advanced RCC;
• a phase 1b clinical trial in combination with the FOLFOX6 chemotherapy regimen in patients with advanced colorectal cancer and other gastrointestinal cancers;
• a phase 1b clinical trial in combination with paclitaxel in patients with metastatic breast cancer; and,
• a phase 1b clinical trial as a monotherapy in patients with non-small cell lung cancer.

We expect that the results of these clinical trials will help to inform our clinical development plans for tivozanib in additional indications.

 

 

Access to Tivozanib

 

To find out more about these trials, please visit  www.clinicaltrials.gov or contact AVEO’s clinical operations department at clinicaltrials@aveopharma.com.

 

For additional patient resources online, please visit:

 

Kidney Cancer Association
American Cancer Association
Cancer Care
National Cancer Institute