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sunitinib (Sutent) and Bayer and Onyx Pharmaceuticals’ sorafenib (Nexavar). Researchers hope that more selective VEGF receptor blockers will be more effective, and that they might avoid blocking similar receptors on healthy cells—which can cause side effects.
Aveo has a pretty clear idea of how this drug ought to perform in this big study of 517 patients. The company already conducted a mid-stage, placebo-controlled trial of 272 patients which showed that tivozanib was able to keep tumors from spreading for a median time of 11.8 months—a finding that was reported at the American Society of Clinical Oncology meeting in June 2009. Aveo has now seen this key measurement of effectiveness stretch out as long as almost 15 months, Ha-Ngoc has said.
Based on that finding, Aveo structured this ongoing pivotal trial to give itself the best chance of success—winning FDA approval. The company designed the study to directly compare how patients do on its treatment, versus the currently approved drug from Bayer and Onyx. This pivotal study is designed to be a success if it can keep tumors from spreading for at least three more months than the Bayer/Onyx comparator, Ha-Ngoc says. Bayer and Onyx’s drug has shown in separate studies that it can hold tumors in check for a median time of about 5.5 months, or 6.7 months in the very best case, Ha-Ngoc has said. So essentially, if history repeats itself from Aveo’s past experience, and past studies from the competition, then Aveo should be able to easily add another three months of what is known as progression-free survival.
“We share AVEO’s vision for oncology drug development and confidence that the TIVO-1 trial is positioned for success,” said Masafumi Nogimori, president and chief executive officer of Astellas, in a statement.
But if Aveo really does nail this pivotal trial with results that will satisfy the FDA and regulators around the world, it will soon need to think about how to extend the franchise into other tumor types.
This is a key point where the Astellas deal fits in. However, the deal helps a small company like Aveo with 150 employees to develop the drug for more types of tumors, building on the firm’s current work in kidney, breast, and colon cancers. (The firm isn’t yet saying what those new areas will be.) Astellas has also shown that it is committed to the oncology field, having bought the cancer drug developer OSI Pharmaceuticals last year for $4 billion, Ha-Ngoc points out.
While Aveo is giving up some ownership of its lead drug in this deal, Ha-Ngoc says that the Astellas partnership also makes the potential size of the business around the product larger than before. “I always say, in laymen’s terms, that I don’t mind sharing the pie,” he says, “as long as the partnership would allow me to get to a bigger pie faster.”
About 58,000 people in the U.S. get diagnosed with kidney or renal cancer each year, and about 13,000 die from it each year, according to the American Cancer Society.
Renal cell carcinoma, which accounts for 90 percent of kidney malignancies, is highly resistant to traditional chemotherapy drugs and existing treatments typically offer less than a year of progression-free survival and cause side effects, according to Aveo.
Aveo is also one of the fastest-growing biotechs in the Boston area, where it was founded in 2002 based on research at Dana-Farber Cancer Institute. Ha-Ngoc says that the company plans to add 70-75 workers this year, growing the ranks of the firm by about 50 percent from the 150 people it now employs.