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of presentations in advance of its full conference from June 4-8. But here’s what I was able to gather about this trial from the public record, and Schatzman.
The Alder cancer study enrolled 124 patients who had terminal forms of non-small cell lung cancer, and who were so sick they had lost at least 5 percent of their body weight and gone off their chemotherapy. Patients were randomly assigned to get a low, medium, or high dose of the Alder intravenous drug every eight weeks, or a placebo infusion. Researchers followed the patients for about six months to see how they did.
The main goal of the study was safety, not efficacy. But Alder designed the trial with enough patients enrolled to demonstrate a statistically significant benefit on some key secondary questions. Those questions were whether patients on ALD518 were able to maintain or gain weight, how much strength they had for a hand grip test, how well they scored on a common fatigue questionnaire known as SF-36, and a measurement of their thrombotic tendency. That last question is important, because markers of inflammation are thought to break lose clots (thrombus), which have a tendency to cause trouble like heart attacks and strokes. Many cancer patients actually are thought to die because their red-hot inflammation rips loose a clot that leads to a fatal stroke or heart attack, Schatzman says.
Importantly, the trial wasn’t designed to ask whether ALD518 shrinks tumors, like most trials.
While Alder isn’t disclosing the results, Schatzman did tell me that Alder’s drug showed advantages over a placebo on all the scores, and they were statistically significant. Since Alder wants to unveil the details in a proper scientific forum with a lot of influential cancer physicians in the audience, we will all have to wait and see the actual results at the ASCO conference.
Still, the data is compelling enough for Alder to plot its next steps. The company is working on a lower-dose IV formulation of ALD518 that can be given every three weeks, so it can be given conveniently on the same schedule on which many cancer patients get their chemo infusions. Alder is working to pick the right patient population, and the right questions to ask in the study so the company can impress physicians and the FDA that it truly has a winner. The trial coming up at next month’s ASCO isn’t offering anywhere near enough proof, and Alder knows it. “We’re trying to move forward in a stepwise fashion.”
Mark Monane, an analyst with Needham & Company and an MD trained in geriatric medicine, told me last month at a Seattle investor conference that he was intrigued by Alder’s cancer-fighting approach. Monane has been following cancer companies like Seattle-based Dendreon for more than a decade, and knows that company’s appeal is deeply rooted not just in a cancer drug that helps people live longer, but that is based heavily on improved quality of life.
“Cancer cachexia is a real problem,” Monane said. “We focus a lot on drugs that kill tumors, but not as much on actually helping the patient. This is something that can help the patient, and you can get an answer on that relatively quickly.”