Table 1. Recent positive clinical phase III trials using therapeutic cancer vaccines (upper panel) and currently ongoing randomized phase III trials in NSCLC (lower panel).
| Vaccine | Target/Approach | Patients/Treatment | Results (vs control) | Trial/Reference |
| Provenge® (Sipuleucel-T) | Dendritic cells + prostatic acid phosphatase (PAP) | •Metastatic, androgen-independent prostatic adenocarcinoma (n=512) | •Median survival 25.8 months vs 21.7 months | IMPACT/(6) |
| •Co-administration with GM-CSF | •31.7% 3-year survival rate vs 23.0 % | |||
| BiovaxID | Autologous tumor cells fused with murine/human heterohybridoma to produce idiotype (then conjugated to KLH) | •follicular lymphoma in complete remission for at least 6 months following PACE CTX | •Of 177 randomized patients, 117 maintained CR ≥ 6 months after PACE CTX | BV 301/(7) |
| •Co-administration with GM-CSF | •Median time to relapse: 44.2 months vs 30.6 months | |||
| Gp100 antigen + Montanide ISA | Modified gp100:209-217 (210M) peptide | •HLA-A0201 positive, locally advanced stage III or IV cutaneous melanoma | •Objective response rate 22.1% vs 9.7% | CCCGHS-NCI-T98-0085/(8) |
| •Vaccine followed by high dose IL-2 vs IL2 alone | •PFS 2.9 months vs 1.6 months | |||
| Stimuvax® (L-BLP 25) | MUC1 | •Unresectable stage III NSCLC | Pending | START/NCT00409188 |
| •SD or better after first line RCT | ||||
| •Estimated enrollment: 1322 | ||||
| •Primary endpoint: survival | ||||
| recMAGE-A3 + AS15 | MAGE-A3 | •Resectable stages IB-IIIA NSCLC | Pending | MAGRIT/NCT00480025 (30) |
| •MAGE-A3-expression on tumor | ||||
| •Estimated enrollment: 2270 | ||||
| •Primary endpoint: DFS | ||||
| EGF-rP64K + Montanide ISA51 | EGF | •NSCLC stage IIIB/IV | Pending | NCT00516685 |
| •Estimated enrollment: 230 | ||||
| •Primary endpoint: OS | ||||
| Lucanix® (Belagenpumatucel-L) | Allogeneic cell lines + TGFβ antisense | •NSCLC stages III/IV | Pending | STOP/NCT00676507 |
| •SD or better following front-line platinum-based CTX | ||||
| •Estimated enrollment: 700 | ||||
| •Primary endpoint: OS |
GM-CSF: granulocyte/macrophage-colony stimulating factor; KLH: keyhole limpet hemocyanin; PACE: prednisone, doxorubicin, cyclophosphamide, etoposide; CTX: chemotherapy; HLA: human leukocyte antigen; IL-2: interleukin-2; DFS: disease-free survival; OS: overall survival