Update: On October 12, 2018, Affimed N.V. received a notification from the U.S. Food and Drug Administration (FDA) saying the agency concurred with Affimed’s decision and formally placed the investigational new drug application for AFM11 on full clinical hold. Affimed said it will comply with the FDA and other global health authorities’ requests for information to resolve the clinical hold.
Affimed N.V. has placed trials of AFM11 on clinical hold and notified the global health authorities of its decision.
AFM11 is a CD19/CD3-targeting T-cell engager being evaluated in two phase 1 trials—one in patients with relapsed or refractory, CD19-positive B-cell non-Hodgkin lymphoma (NHL) and one in adults with relapsed or refractory B-precursor acute lymphoblastic leukemia (ALL).
Affimed initiated the clinical hold on these trials after serious adverse events occurred in three patients treated with AFM11.
This included a death in the ALL study and two life-threatening events in the NHL study.
The serious adverse events occurred in patients enrolled in the highest dose cohorts of each study.
Affimed said it will be working closely with the global health authorities, safety monitoring committees, and the studies’ clinical investigators to review the adverse events, assess all the data, and determine next steps for the AFM11 program.
Affimed intends to provide an update on AFM11 upon completing the evaluation.