Neratinib and Veliparib wins Spy-2

jenrio

Quote:

Both drugs were tested in an unconventional mid-stage trial called I-Spy 2. The trial involves patients with cancers confined to the breast, where a cure is possible but the disease is at high risk of spreading to other parts of the body. In one of the novel features of the study, the drugs were measured on their ability to eradicate the cancer in just six months, before any surgery to remove tumors.

Veliparib, for instance, when combined with the drug carboplatin and a six-month regimen of standard chemotherapy, achieved a complete response in 52% of patients compared with 26% for patients treated with standard chemo alone, according to results presented Friday at the annual San Antonio Breast Cancer Symposium.

Typically, late-stage cancer drug studies succeed only 30% to 40% of the time, said Laura Esserman, director of the breast care center at University of California San Francisco and co-leader of I-Spy 2. Such trials can involve several thousand patients--many of whom wind up taking drugs that don't help them--and can take nearly a decade to get an answer.

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Whether the promising results will translate into a speedier approval--or any approval at all--isn't assured. A key to the I-Spy strategy is that the FDA accepts a complete response at six months--meaning that no residual cancer cells can be detected after the tumor and lymph nodes are removed--as a surrogate for a long-term benefit. The aim is for FDA to allow a drug on the market on that basis, on the condition that follow-up research demonstrates a long-term benefit.

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Partly to address the long-term issue, Dr. Esserman and her colleagues are launching a new trial called I-Spy 3, an international study in which they hope to enroll enough patients for each drug studied to test both the early complete response and the long-term follow up.

If a company going through such a process was able to file successfully with the FDA for accelerated approval, with a confirmatory trial well under way, "that should get agents to the market three to four years earlier," Dr. Esserman said.

http://online.wsj.com/article/BT-CO-20131213-705589.html?dsk=y