Table 2.
Phase III and Phase II MUC1-targeted clinical trials.
| Vaccines | Type | Cancer | Clinicl outcomes |
|---|---|---|---|
| L-BLP25 | Adjuvanted subunit vaccines | NSCLC (phase III) | No difference in overall OS or TTP with placebo. Significantly improved OS in concurrent chemoradiotherapy group. |
| NSCLC (phase II) | Significantly improved survival time in stage IIIB NSCLC loco-regional disease compared with supportive care. | ||
| Early BC (phase II) | Neoadjuvant L-BLP25 is safe, but does not improve RCB or pCR rates compared with neoadjuvant standard-of-care treatment. | ||
| TG4010 | Viral vector vaccines | NSCLC (phase IIb/III) | TG4010 plus chemotherapy improve PFS relative to placebo plus chemotherapy. |
| Renal clear-cell carcinoma (phase II) | TG4010 plus cytokines is well tolerated in patients with metastatic renal clear-cell carcinoma. | ||
| Prostate cancer (phase II) | TG4010 is well tolerated, and has biological activity in patients with PSA progression. | ||
| STn-KLH | Glycopeptide vaccines | Metastatic BC (phase III) | STn-KLH is well tolerated, but no overall benefit in OS or TTP compared with KLH alone. |
| Dendritic cell/myeloma fusion vaccine | Dendritic cell vaccines | Multiple myeloma (phase II) | Vaccination following autologous stem cell transplantation can induce significant expansion of myeloma-specific T cells and cytoreduction of minimal residual disease. |
| Cvac | Dendritic cell vaccines | Epithelial ovarian cancer (phase II) | Cvac immunotherapy is well tolerated and can led to CA125 decline or stabilization. |
| DC/PANVAC | Dendritic cell vaccines | Colorectal cancer (phase II) | Survival was longer for vaccinated patients than for a contemporary unvaccinated group. |
| DC/Tn-MUC1 | Dendritic cell vaccines | Nonmetastatic castrate-resistant prostate cancer (phase I/II) | Vaccination is safe and can induce significant T-cell responses. |
| WT1/MUC1-DC | Dendritic cell vaccines | Pancreatic ductal adenocarcinoma (phase I/IIa) | WT1/MUC1-DC vaccination in the adjuvant setting is safe and well-tolerated in pancreatic ductal adenocarcinoma patients after tumor resection. |
| ImMucin | Adjuvanted subunit vaccines | Multiple myeloma (phase I/II) | ImMucin can induces T- and B-cell specific immune response. |
| Naked mRNA | RNA vaccines | Renal cell carcinoma (phase I/II) | Vaccination can elicit immunological responses and result in a clinical benefit in patients with metastatic renal cell carcinoma. |
OS: overall survival; RCB: residual cancer burden; TTP: time to progression; pCR: pathologic complete response.