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the design of the needed confirmatory trial. While negotiating with the FDA, it was getting all of its other ducks in a row, briefing doctors and nurses on what the trial design would be like, so they could hit the ground running once the FDA gave the official green light. Because of all that spadework, the full roster of 100 patients is expected to be full before the end of September.
After that, the company, doctors and patients, will simply to have to wait for a year’s worth of observations to trickle in before drawing any conclusion about whether the drug works. If the trial succeeds, Seattle Genetics will be ready to bring forward the first new treatment in 30 years for Hodgkin’s and related lymphomas, which affects an estimated 10,000 patients in the U.S.
There are many reasons why patients have flocked to the drug, Reynolds says. There’s some online buzz among patients who have heard about the provocative, if preliminary, evidence from the Phase I trial. There’s also some scientific novelty, in that this drug isn’t like a typical chemotherapy. The treatment uses an antibody designed to seek out a specific target found on cancer cells. The antibody is loaded with a potent toxin to give it extra tumor-killing punch.
Convenience also helps. The drug only needs to be infused once every three weeks, making it manageable for patients who travel long distances to see their doctor. There aren’t many competing drugmakers trying to enroll these same patients in a trial, other than Novartis, which is studying panobinostat, Reynolds says. And, the Seattle Genetics trial is designed so that all patients who enroll are guaranteed to get the experimental medicine—there’s no 50-50 shot that patients will randomly get stuck with a placebo, or a lackluster regimen of standard chemotherapy.
This means the Seattle Genetics trial doesn’t meet the usual gold standard of medical evidence for comparison—in which patients with similar characteristics are randomly assigned to get an experimental drug or the existing standard of care. But cancer drugmakers sometimes try to avoid this design, because they think they can save time and money with a simpler trial, while still getting a definitive answer on whether their experimental drug is any good.
When asked if the single-arm nature of the study helped speed up enrollment, Reynolds says, “it certainly doesn’t hurt.”
Seattle Genetics says it gave a lot of thought to the pros and cons … Next Page »
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