For Patients

Who is AVEO?

 

AVEO Pharmaceuticals is an innovative biotechnology company. AVEO integrates a proprietary cancer biology platform with drug development and commercial expertise in its efforts to discover and develop targeted cancer therapeutics. Driven by our commitment to cutting-edge science, and the passion of the AVEO team to develop novel cancer treatments that positively impact patients’ lives, AVEO is moving toward realizing its vision of becoming a fully integrated cancer therapeutics company.

 

Tivozanib, our lead product candidate, specifically targets the vascular endothelial growth factor (VEGF) pathway. VEGF is a substance produced by the body that stimulates growth of new blood vessels. When VEGF and the receptors to which it binds are “over-produced,” it can contribute to the growth of certain cancers. By blocking the VEGF pathway, cancer cells are starved of the blood and nutrients they need to survive and grow. This mechanism has shown benefit for patients with a wide range of cancer types, including kidney cancer (renal cell carcinoma, or RCC), metastatic breast cancer, colorectal cancer, non-small cell lung cancer, liver cancer and brain cancer.

 

Tivozanib: A Highly Potent and Targeted VEGF Receptor Inhibitor

 

AVEO’s clinical trials of tivozanib to date have demonstrated a favorable safety and efficacy profile for tivozanib. Due to tivozanib’s potency and specificity, we believe that it may effectively stop or inhibit 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 single treatment, or monotherapy. It may also allow tivozanib to be more readily combined with standard chemotherapy as well as other targeted therapies, potentially increasing its utility in the treatment of other cancers. Tivozanib is currently being studied as a once-daily oral treatment of certain cancers and has not yet been approved by the U.S. Food and Drug Administration (FDA).

 

TIVO-1: A Phase 3 Trial of Tivozanib in Patients with Kidney Cancer

 

AVEO has initiated patient enrollment in TIVO-1, a global Phase 3 clinical trial of tivozanib in approximately 500 patients with advanced RCC who have not received prior VEGF-targeted therapy. TIVO-1 is evaluating the efficacy of tivozanib compared to Nexavar® (sorafenib), an FDA and EMA approved therapy for RCC. Patients enrolled in TIVO-1 are randomized 1:1 to receive tivozanib or Nexavar. TIVO-1 is the first-ever Phase 3 study in RCC designed to evaluate superiority in a head-to-head comparison against a widely prescribed anti-angiogenesis therapy in first-line RCC. The primary endpoint of the trial is to compare the PFS of tivozanib vs. Nexavar. Secondary endpoints include overall survival, objective response rate, safety and quality of life. Patients who demonstrate disease progression during treatment with Nexavar will have the opportunity to be treated with tivozanib by participating in a separate long-term treatment protocol.

 

This trial is currently enrolling patients and is being led by Robert Motzer, M.D. from the Memorial Sloan-Kettering Cancer Center. Individuals with RCC of clear cell histology that have had a prior nephrectomy and that have not received prior VEGF-targeted therapy are eligible for TIVO-1.

About Renal Cell Carcinoma (RCC)

 

Renal cell carcinoma (RCC) is cancer of one or both of the kidneys. The American Cancer Society estimates that there are more than 50,000 new cases of renal cell cancer diagnosed each year. Advanced RCC, which accounts for 80-85% of all malignant kidney tumors, can be very difficult to treat, which is why new treatment options are desperately needed. AVEO is working with leading treatment centers across the country to learn more about tivozanib as a viable treatment option for RCC and other cancers.

 

Additional 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:

• 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;
• Phase 1b clinical trial in combination with the FOLFOX6 chemotherapy regimen in patients with advanced colorectal cancer and other gastrointestinal cancers;
• Phase 1b clinical trial in combination with paclitaxel in patients with metastatic breast cancer; and,
• 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 AVEO Clinical Trials

 

To find out more about AVEO's ongoing clinical trials evaluating tivozanib and AV-299, please visit www.clinicaltrials.gov, or contact AVEO’s clinical operations department at clinicaltrials@aveopharma.com, or by phone at 617-299-5808.

 

For additional patient resources online, please visit:

 

Kidney Cancer Association
American Cancer Association
Cancer Care
National Cancer Institute