The Breakthrough Therapy Designation was supported by a Phase 2 study in patients with metastatic TNBC who had received a median of 5 prior therapies (range, 2 – 12).
“We believe Breakthrough Therapy Designation for IMMU-132 further validates this potential therapeutic for patients with TNBC, and we are delighted to receive this important recognition,” commented Cynthia L. Sullivan, President and Chief Executive Officer.
Ms. Sullivan further stated, “IMMU-132 is also in Phase 2 trials in patients with advanced, heavily-pretreated, non-small-cell lung cancer, small-cell lung cancer, and urothelial cancers, where encouraging results have been observed. The Trop-2 receptor targeted by this antibody-drug conjugate has increased expression in a large number of solid cancers. To date, we have enrolled about 300 patients with diverse cancer types.”