Table 1 Summary of major cell therapies for solid tumors (approved by FDA or with positive results in a randomized clinical trial)

From: Unlocking the potential of engineered immune cell therapy for solid tumors

Cell product

Setting

Results

Evidence

Status

Autologous non-selected TILs (lifileucel)

Advanced melanoma refractory to anti-PD1 + /- BRAF/MEK inhibitors (median 3 prior lines)

ORR 31.4% (CR 5.2%); mPFS: 4.1 m; mOS: 13.9 m

Multicenter phase II non-randomized trial (n: 153)57

Approved by FDA (Feb 2024)

Autologous non-selected TILs (academic)

Advanced melanoma (11% in 1st line; 86% refractory to anti-PD1 therapy)

ORR 49% (CR 20%); mPFS: 7.2 m; mOS: 25.8 m

Multicenter phase III randomized trial (n: 168)1

Not approved

MAGE-A4-targeted TCR-T therapy (afamicel)

Unresectable or metastatic synovial sarcoma refractory to chemotherapy (HLA-A*02)

ORR 39%; mPFS: 3.8 m; mOS: 15.4 m

Multicenter phase II non-randomized trial (n: 44)58

Approved by FDA (Aug 2024)

  1. ORR overall response rate, CR complete response, PR partial response, mPFS median progression-free survival, mOS median overall survival.
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