The Data Monitoring Committee decided to stop enrollment following an independent recommendation that no new or recently enrolled patients continue treatment in the trial because of safety concerns related to thromboembolism (blood clots) in the experimental arm of the study.
However, necitumumab will continue to be studied in a Phase III trial named SQUIRE primarily because no safety concerns have been observed in this control arm of the study.
Lilly oncology product development and medical affairs vice president Richard Gaynor said that stopping enrollment in one of the two Phase III trials is disappointing but patient safety must be treated as paramount.