A trans-Atlantic study to evaluate an antibody for treatment of B-cell non-Hodgkins lymphoma is still almost three years from completing patient follow-up, but already it has succeeded beyond expectations in the form of five patients declared disease-free a year and counting.
The Phase 2 trial involved a CD19 antibody that was tested at 26 sites — 22 in Europe and four in the United States. Ninety-two patients enrolled in the study, which set out to evaluate the compound’s efficacy in treating four NHL subtypes: FL (follicular lymphoma), DLBCL (diffuse large B-cell lymphoma), MCL (mantle cell lymphoma), plus a fourth, a type of indolent NHL.
Recruiting beats schedule by six months
Based on early findings, the sponsor narrowed the scope to subtypes FL and DLBCL, where the drug showed the most promise. Patient recruiting was a particular challenge for the mantle cell population, as MCL is one of the disease’s rarer instances. Nevertheless, the last patient signed on about six months ahead of schedule, a feat our project manager attributed to frequent contact between study sites and the project team. When the trial completed its planned treatment rounds and entered follow-up, the sponsor saw spectacular results: five patients who demonstrated complete response to the therapy and were cancer-free after more than a year. Improving patients’ lives is always among our foremost goals, but to have five of these participants exhibit no disease over this period was quite unexpected, according to the project manager.
Adding a maintenance component
On the strength of that discovery, the sponsor expanded the trial to include a maintenance component that is ongoing alongside the follow-up period. Follow-up is scheduled for completion in January 2020.
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