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Session V — Lifetime Achievement: Steven Rosenberg

Forty Years of Teaching the Immune System to Kill Cancer

Steven Rosenberg (Chief of Surgery Branch, NCI since 1974) traces the arc from IL-2 to TIL to the first human gene transfer to neoantigen-targeted cell therapy for solid epithelial cancers.


Key Milestones

IL-2 Era (1980s–1990s)

  • 1984: first durable immune-mediated regression of metastatic cancer — patient disease-free 40 years later
  • IL-2 became the first FDA-approved cancer immunotherapy (renal cancer 1992, melanoma 1998)
  • ~17% objective response, 8% complete — but complete responders almost never recurred

TIL Therapy in Melanoma

  • 192 patients: 56% objective response, 25% durable complete responses
  • 46 of 48 complete responses lasted >10 years
  • Lifileucel (commercial TIL) FDA-approved 2024

First Human Gene Transfer (May 22, 1989)

  • First foreign gene ever placed in a human — a tracking marker in T cells
  • Contested RAC vote, lawsuits, regulatory battles
  • Established safety of retroviral gene transfer into human T cells

CAR-T Origins

  • First patient to undergo cancer regression after CAR-T — 48-year-old NHL patient, CR ongoing past 14 years
  • Technology licensed to Kite Pharma → acquired by Gilead for $11.9B (2017)

Neoantigen-Targeted Cell Therapy

The current frontier — targeting mutations in solid epithelial cancers (90% of cancer deaths):

Three Approaches

  1. Selected TIL — isolate only neoantigen-reactive subset
  2. TCR transduction — clone reactive TCR into patient’s normal lymphocytes
  3. Shared-mutation TCRs — libraries against KRAS and p53 hotspot mutations (present in ~30% and ~50% of all cancers)

Recent Results

  • Selected TIL in chemo-refractory pancreatic/colorectal/cholangiocarcinoma: ~24% RECIST response rate
  • KRAS G12V–targeted TCR: pancreatic cancer regression
  • p53 R175H–targeted TCR: colorectal liver/lung mets shrinking
  • 2014 cholangiocarcinoma patient: disease-free 12 years out

“Any intracellular protein can become a cancer antigen if it is mutated. The good news: virtually all cancers have mutations. The bad news: it is highly individualized.”