Table 2.
Cancer Vaccines Currently in Advanced Proof of Efficacy Phase III Clinical Trials in NSCLC.
| Vaccine | Level of Evidence | Therapeutic Context |
Effect on PFS | Effect on SV | Ongoing Phase III Trial | Reference |
|---|---|---|---|---|---|---|
| MAGE-A3 (Full protein AS02B or AS15) |
Phase II Placebo controlled clinical trial (n = 182) |
Post-resection of early-stage pIB to II NSCLC | Improved DFI (HR 0.73; P = 0.109) | No evidenced | Resected stages pIB to IIIA NCT00480025 (MAGRIT) Ongoing—target 2270 Primary endpoint: DFS |
Vansteenkiste J, Zielinski M, Dahabre J et al. JCO 2007; 25 (Suppl 18): 398S. (Abstr). |
| Emepepimut-S or Stimuvax (L-BLP25/ MUC1-peptide Liposomal formulation) | Phase II Placebo controlled clinical trial (n = 171) |
Post-chemoradiotherapy for unresectable stage III NSCLC | No evidenced | Improved OS (HR 0.74; P = 0.112) |
Unresectable stage III NCT00409188 (START) Recruited—N = 1464 Primary endpoint OS |
Butts C, Murray N, Maksymiuk A et al. JCO 2005; 23: 6674–6681. |
| Lucanix (Belagenpumatucel-L Allogeneic cells TGF-b2 antisense gene modification) | Phase II clinical trial (open dose comparison) | Advanced Stages II to IV NSCLC added to ChT and Maintenance after ChT | No evidenced | Clinical response 15% Better survival in high-dose group |
Advanced stage III/IV NCT00676507 (STOP) Ongoing—target 700 Primary endpoint OS |
Nemunaitis J, Dillman RO, Schwarzenberger PO et al. JCO 2006; 24: 4721–4730. |
| TG4010 (MUC1-peptide IL-2 co-expressing viral vector) |
Phase II Placebo controlled clinical trial (n = 148) |
Stages IIIB and IV | PFS at 6 months 44% versus 35% (P = 0.13) |
No evidenced | Advanced stage IIIB/IV NCT01383148 Planned—target 1000 Primary endpoint OS |
Quoix E, Ramlau R, Westeel V et al. Lancet Oncol 2011; 12: 1125–1133. |
| Racotumumab | Compassionate clinical study (n = 71) |
Stages IIIB and IV | No evidenced | Vaccinated 9.93 months vs. Controls 4.53 months | Advanced stage IIIA (non-resectable), IIIB/IV NCT01460472 Planned—target 1082 Primary endpoint OS |
VÁzquez AM, et al. Frontiers in Oncology 2012 2(10)150 1-6. |
| CIMAvax EGF (hu-recEGF/ P64k/ Montanide ISA 51 adjuvant) |
Phase II Placebo controlled clinical trial (n = 80) |
Stages IIIB and IV Switch maintenance after first line platinum- based ChT Use beyond progression Chronic use |
No evidenced | 3.5 month for 60 years old and younger | Advanced stage IIIB/IV NCT00516685 Ongoing—target 230 Primary endpoint OS |
Neninger Vinageras E, De La Torre A, Osorio Rodriguez M et al. JCO 2008; 26: 1452–1458. |