Pesky Primate Plans Projectile Pitches

If you’ve ever spent time watching chimps at the zoo, you’ve probably wondered: what are they thinking? Well, the answer might be simple: could be they’re fixin’ to hurl a rock at your head.

Dendreon’s Provenge Works Best for Patients With Low PSA, Scientists Say

From the moment Dendreon started in business 20 years ago, most scientists have said that if its immune-booster for prostate cancer was going to work, it would probably work best at an early stage of disease, before tumors had gotten too powerful for the immune system to contain. Today, Dendreon is offering the latest slice of data that suggests that may be the case.

The Seattle-based biotech company (NASDAQ: DNDN) is announcing today a new analysis of its pivotal 512-patient study of sipuleucel-T (Provenge), which separated patients into four quartiles based on how high or low their prostate-specific antigen (PSA) scores were. The study wasn’t designed to get a statistically significant answer to this question, meaning the finding could be a fluke. Still, the results do align with what many scientists believe based on the history of clinical trials with the product—that it should work better among patients with less-aggressive forms of disease. The analysis, by lead author Gerald Chodak at Weiss Memorial Hospital in Chicago and colleagues, was posted online today on the American Society of Clinical Oncology’s website, in advance of its annual meeting.

“All of these analyses support the robustness of clinical benefit for patients, and this PSA quartile data is helpful for patients when you think about sequencing of therapy,” says Mark Frohlich, Dendreon’s chief medical officer. “The data strongly argues that using it as early as possible is the best for the patient and still allows you to go on and get other therapies.”

Dendreon won FDA approval back in April 2010 for the first-of-its-kind immune-boosting therapy, after the 512-patient study showed patients lived a median time of about four months longer on the drug than on a placebo, with minimal side effects. Since then, the company has faced a series of new competitive threats, particularly from Johnson & Johnson’s abiraterone (Zytiga) and Medivation’s enzalutamide. Those drugs are starting out by aiming to treat the sickest of prostate cancer patients, whose disease has worsened after getting chemotherapy. Dendreon’s drug is approved for patients with a less-severe form of disease, which hasn’t yet prompted them to go all the way to chemotherapy. Since prostate cancer is a slow-growing malignancy, part of Dendreon’s challenge is to persuade doctors to get more aggressive in treating patients early.

PSA, which isn’t a perfectly reliable marker, is still used almost universally by doctors and patients to track a patient’s progress. The lower the score, generally speaking, the better. In this analysis of the Dendreon study, researchers crunched the data to look at survival times of patients who entered the trial with PSA scores of less than or equal to 22.1; between 22.1 and 50.1; between 50.1 and 134; and over 134. As you can see from the chart below, Provenge patients lived longer than placebo patients in all four quartiles, but the difference in median survival times was the largest among those with lower PSA scores.

This isn’t really a surprising finding, given that Dendreon has previously said that patients with lower PSA scores had better outcomes on Provenge, about to a summary of the trial published in the New England Journal of Medicine. But it’s the first time Dendreon looked more closely at the PSA scores, by dividing patients into quartiles, Frohlich says.

Given how much debate there has always been about the data to support Dendreon’s prostate cancer drug, I’d love to hear readers thoughts on how meaningful the latest PSA analysis is. Do you think the consistency of the survival advantage in all PSA groups means something, or do you chalk this up to mere data dredging that does little more than stir up a new hypothesis? Let me know your thoughts in the comment section below.

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Aveo Kidney Cancer Drug Shows Safety Edge in Pivotal Study

Aveo Pharmaceuticals 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 Pharmaceuticals 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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Devcrossing: CVS CEO Larry J. Merlo Unveils 2011 Corporate Social Responsibility Report http://t.co/ckn6OZpv #csr #sustainability

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