Aveo Kidney Cancer Drug Shows Safety Edge in Pivotal Study

Xconomy Boston — 

Aveo Oncology is entering a competitive world for the treatment of kidney cancer, and it made a bold bet that its drug would prevail in the first head-to-head comparison of its kind against an active drug. Now the company is preparing to enter that competition with data that says its drug has a slight advantage over a rival on effectiveness, and a more meaningful edge on safety and ease of use.

Cambridge, MA-based Aveo (NASDAQ: AVEO) and its partner, Japan-based Astellas Pharma, are announcing today that their experimental drug tivozanib reached the main goal in a pivotal study of 517 patients with renal cell carcinoma. The new drug showed it was able to keep tumors from spreading a median time of 11.9 months, compared with 9.1 months for those who were randomly assigned to get Bayer and Onyx Pharmaceuticals’ sorafenib (Nexavar). The most common side effects for the new drug were high blood pressure, diarrhea, a skin rash called hand-foot syndrome, and fatigue.

Those effects are common for this class of therapy that cuts off blood flow to tumors, but what’s noteworthy here is that fewer patients on the new drug had to go on unplanned drug “holidays,” or have their doses reduced, because of severe side effects. A detailed summary of the findings is being posted on the American Society of Clinical Oncology’s website today, as a preview of an oral presentation at the ASCO conference on June 2.

Aveo CEO Tuan Ha-Ngoc

Aveo, which is seeking to introduce its first marketed product, has said it plans to seek FDA approval later this year based on the results described online today. Its drug, a once-daily pill, is designed to cut off blood flow to tumors by interfering with three different forms of the VEGF receptor, a marker on cells. If the drug can win FDA clearance, it will be in position to compete not just with Bayer/Onyx’s sorafenib (Nexavar), but also with Pfizer’s sunitinib (Sutent) and axitinib (Inlyta), Roche/Genentech’s bevacizumab (Avastin), and GlaxoSmithKline’s pazopanib (Votrient). There’s certainly a large pool of people who are candidates for the new drugs. About 61,000 new cases of kidney cancer were diagnosed in the U.S. last year, and 13,000 people died from the disease, according to the American Cancer Society.

“There are a lot of options but there are also problems with all the existing options,” says Michael Atkins, the deputy director of the Georgetown Lombardi Comprehensive Cancer Center in Washington D.C., and an investigator on the study. “This drug addresses one of those problems, and is therefore an advance.”

Aveo reported the basic headline that the study was a success back in January, but today’s abstract goes into more detail about what researchers found in the study called TIVO-1. The key new information is in the product’s safety profile.

According to research being published today, about 44 percent of patients on the Aveo drug experienced high blood pressure, and 25 percent of those cases were graded moderate to severe, researchers said. That was a slightly higher rate than for patients who got the Bayer/Onyx drug. But that’s not much of a concern because that effect can be managed with anti-hypertensives, Atkins says.

More importantly, fewer patients on the Aveo drug reported hand-foot syndrome (skin rash) or diarrhea. About 13 percent on the Aveo drug reported hand-foot syndrome, compared with 54 percent who got the Bayer/Onyx drug, researchers said. About 22 percent on the Aveo drug reported diarrhea, compared with 32 percent in the control group.

While that might not sound like much of a difference, it translated into a significantly easier drug to administer to patients, Atkins says. Because the Aveo drug caused fewer … Next Page »

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