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of different trial designs. It consulted with many of thought leaders who treat Hodgkin’s patients, as well as the FDA, Reynolds says. The company concluded it wasn’t necessary to run a randomized trial because the only treatment options left for these patients offers slim odds of shrinking tumors and don’t provide lasting benefits. Until brentuximab vedotin (SGN-35) came along, nothing really had changed in standard practice for 30 years. Life expectancy for relapsed patients following a bone marrow transplant was predictable, at about 2.5 years, Reynolds says.
“If we see something similar to what we saw in Phase I, that will be unquestioned data,” Reynolds says. “We believe this pivotal trial, on its own, will be sufficient for accelerated approval.”
Yet when a trial enrolls this fast, I have to wonder whether there are any special pitfalls to watch for. Might doctors get over exuberant, and recruit a hodgepodge of patients, some of whom don’t belong in the study? Are doctors succumbing to bias, and cherry-picking some healthier patients to try to make the drug look better than it is? These are familiar concerns to any trial, and it’s Reynolds job to make sure that doesn’t happen. “We’ve been extremely stringent on the inclusion and exclusion criteria. There are no exceptions,” Reynolds says.
Then again, there are few situations in which experimental cancer drug trials enroll so fast. It happened at least a couple times in the past decade, Reynolds says, with Takeda Pharmaceuticals’ bortezomib (Velcade) for multiple myeloma, and Novartis imatinib (Gleevec) for chronic myeloid leukemia.
Those drugs were such big leaps over the prior standards of treatment that they generated standing ovations at medical meetings. Today both generate more than $1 billion in annual sales. Seattle Genetics has a long road to reach that destination, but in my profile of Reynolds last fall, he said the data on brentuximab vedotin have a lot of similarities with the headliners of the recent past. “It sounds like Gleevec. It sounds like Rituxan,” he said last September.
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