AVEO Oncology Shows Positive Phase 3 Results in Renal Cell Carcinoma

Renal cell carcinoma is the most common type of kidney cancer affecting adults, in which cancer cells form in the tubules of the kidneys. Over 63,000 new cases of kidney cancer will be diagnosed in the US in 2018, according to the American Cancer Society, and about 15,000 people will die from the disease. 338,000 people worldwide are diagnosed with kidney cancer each year, according to the International Kidney Cancer Coalition.

Cambridge, Massachusetts, based AVEO Oncology AVEO is developing a pipeline of therapies for cancer and other areas of unmet need. The company announced positive topline results after the close yesterday from the primary analysis of its Phase 3 “TIVO-3” trial comparing tivozanib to sorafenib (marketed as Nexavar by Bayer and Onyx) in 351 subjects with highly refractory advanced or metastatic renal cell carcinoma who have failed at least two prior treatment regimens. The primary endpoint of the study was achieved, tivozanib demonstrating a statistically significant benefit in progression-free survival (PFS). Patients on tivozanib showed a 44% improvement in median PFS and 26% reduction in risk of progression or death. According to AVEO, this was the first and only positive result from a Phase 3 study in third and fourth-line renal cell carcinoma. The company plans to file a new drug application with the FDA in about six months.

Source: AVEO Oncology

Tivozanib is an oral, once-daily, vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI) that was approved in August 2017 in the European Union, Norway and Iceland for the treatment of adult patients with advanced renal cell carcinoma. VEGF is a key mediator of new blood vessel development (angiogenesis), which can fuel the growth of cancer in the body, while tyrosine kinases play a critical role in the signaling of growth factors such as VEGF. Tivozanib is a potent, selective and long half-life inhibitor of all three VEGF receptors and is designed to optimize the blocking of VEGF, thereby inhibiting angiogenesis, while while minimizing off-target toxicities. Tivozanib is marketed in the EU as Fotivda by EUSA Pharma, AVEO’s European licensee.

Source: AVEO Oncology

Tivozanib’s therapeutic profile is distinct among VEGF TKIs as a treatment for RCC, with the TIVO-3 trial demonstrating a significant PFS benefit and a favorable tolerability profile. In the advanced disease setting, these outcomes are particularly meaningful, providing the first large, pivotal dataset that shows sequencing of treatment following earlier TKI and immunotherapy treatment. This profile suggests an important place for tivozanib in the evolving treatment paradigm for RCC and, taken together with early combination data, the need to study tivozanib further in combination with immunotherapies.

-Brian Rini, MD, Professor of Medicine, Cleveland Clinic Lerner College of Medicine of Case Western Reserve University, Director, Cleveland Clinic Genitourinary Cancer Program, and principal investigator of the TIVO-3 trial.

It’s been a long road for AVEO and tivozanib. In 2013, the FDA rejected AVEO’s application for tivozanib, saying that the trial results were uninterpretable and inconclusive, and recommending that another Phase 3 trial be conducted. In 2015, the company decided to pursue approval in the European market for tivozanib, a decision which was rewarded by the drug’s approval in 2017. It’s been over seven years since the stock traded in the $20s, but this data from the most recent Phase 3 trial may give long investors reasons to participate once again, particularly at about a tenth of the former price.

Our determination to fight for tivozanib in 2015, when AVEO faced an important strategic crossroads, came from our belief that it could have a meaningful impact not just on how a disease was treated, but also what the patient experiences through that treatment. Today’s outcome is the culmination of that multi-year effort, and a first step in our goal to improve both outcomes and patient experience. We owe our deepest gratitude to the healthcare professionals, many of whom long believed in the potential of tivozanib, and to the patients and their families for participating in our pivotal studies.

– Michael Bailey, President and CEO AVEO Oncology.

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