Nearly four decades after it was first conceived, the first TIL therapy, an immunotherapy that harvests cancer-fighting immune cells from a patient's own body, received accelerated approval from the Food and Drug Administration for advanced melanoma. Iovance's therapy, called Amtagvi or Lifileucel, is the first approved cell therapy for a solid tumor.
“It's so exciting and gratifying,” said Allison Betof Warner, a cell therapy researcher and physician at Stanford University who worked on Amtagvi. “This is a groundbreaking moment for our field. We have seen great success with cell therapy in hematological malignancies, and we have yet to capitalize on this in solid tumors. Hopefully this is the first of many to come.”
In a Phase 2 clinical trial called C-144-01, 153 patients who had received a median of three prior lines of therapy received lifileucel, and 31% of them responded to therapy. “These are very late patients. They have exhausted all standard care options,” said Betof Warner. “The most promising part of this therapy to me is that 42% of patients who responded continued to respond for 18 months or longer. It is really incredible.”
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