Table 1 Published clinical trials of metastatic HER2 + breast cancer patients treated with immunotherapy
From: Immunotherapy in HER2-positive breast cancer: state of the art and future perspectives
Name | Drug | Phase | Setting | Number of HER2-positive patients | Type of intervention | Mechanism of action | Outcomes |
|---|---|---|---|---|---|---|---|
Diéras et al. [7] | TDM-1 | III | Metastatic | 991 | HER2+ block enhancer | Antibody conjugate | -PFS (p < 0.001) -OS (p < 0.001) |
Bang et al. [67] | Margetuximab | I | Metastatic | 27 | HER2+ block enhancer | ADCC stimulation against HER2 receptor | -Dose finding -Clinical benefit rate |
Alsina et al. [68] | MCLA-128 | I/II | Metastatic | 8 | HER2+ block enhancer | ADCC stimulation against HER2/HER3 receptors | -Dose finding -Clinical benefit rate |
Borghaei et al. [69] | 2B1 | I/II | Metastatic | 20 | HER2+ block enhancer | NK stimulation against HER2 receptor | -Objective response rate -OS -TTP |
Dirix et al. [70] | Avelumab | Ib | Metastatic | 26 | Immune check point inhibitor | Anti PD-L1 | -Objective response rate -PFS -OS |
Manguso et al. [71] | Pembrolizumab | Ib/II | Metastatic | 58 | Immune check point inhibitor | Anti PD-1 | -Disease control (PD-L1 neg) -PFS -OS |
Disis et al. [72] | NA | I/II | Metastatic | 22 | Vaccine | Peptide-based vaccine | Immunological response |
Curigliano et al. [73] | NA | I/II | Metastatic | 40 | Vaccine | Recombinant HER2 protein + immunostimulant | -PFS -Objective response rate |
Hamilton et al. [74] | NA | I | Metastatic | 12 | Vaccine | Recombinant HER2 protein + immunostimulant + Lapatinib | Immunological response |
Miles et al [75] | NA | III | Metastatic | 157 (15% of total patients) | Vaccine | Mucine-epithope (STn-KLH) | Overall TTP Overall OS (p = 0.916) |
Heery et al. [76] | PANVAC | II | Metastatic | 6 (12% of total patients) | Vaccine | DNA-based vaccine | Overall PFS (p = 0.09) |
Norell et al. [77] | NA | I | Metastatic | 8 | Vaccine | Plasmid vector-based vaccine | Immunological response |
Tiriveedhi et al. [78] | NA | I | Metastatic | 3 (21% of total patients) | Vaccine | DNA-based vaccine | -Immunological response -Overall PFS (p = 0.011) |
Morse et al. [79] | NA | I | Adjuvant/ Metastatic | 7 | Vaccine | Dendritic cell vaccine | -Immunological response - DFS |
Emens et al. [80] | NA | I | Metastatic | 1 (0.03%of total patients) | Vaccine | Anti-HER2 allogenic breast cancer cell line | Immunological response |
Dols et al. [81] | NA | I | Metastatic | 12 (43% of total patients) | Vaccine | Allogenic breast cancer cell lines | -Immunological response -TTP -OS |
Chen et al. [82] | NA | Metastatic | 22 | Vaccine | Granulocyte macrophage colony-stimulating factor (GM-CSF)–secreting tumor vaccine | -Immunological response -Objective response rate -PFS -OS | |
Park et al. [83] | Lapuleucel-T | I | Metastatic | 19 | Vaccine | Dendritic cell based vaccine | -Immunological response -Objective response rate |
Disis et al. [84] | NA | I | Metastatic | 7 | Vaccine | Autologous T-cell vaccine | -Immunological response -Objective response rate |