Table 2.
Summary of novel NMIBC therapies, clinical trials, and associated results of the trials.
| Drug | FDA Approval | Study | Mechanism of Action | Number of Pts in Study | Response Rate | Reported Response Duration | Cystectomy free rate |
|---|---|---|---|---|---|---|---|
| Anktiva (N-803) | Yes | Quilt 3.302 | Activation and proliferation of natural killer and CD8 + T cells | CIS (n=83); nonCIS (n=77) | CIS 71%; nonCIS 48% | 24 months | CIS 91%; nonCIS 95% |
| Pembrolizumab | Yes | KEYNOTE-057 | Monoclonal antibody binds to PD-1 inhibiting interaction with PD-L1 and PD-L2 | 96 | 41% | 16.2 months | Not Reported |
| Atezolizumab | No | SWOG S1605 | PD-L1 inhibition | 129 | 27% | 6 months | Not Reported |
| Sasanlimab | No | CREST | Monoclonal antibody binds to PD-1 inhibiting interaction with PD-L1 and PD-L2 | Preliminary results not reported | Not yet reported | Not yet reported | Not yet reported |
| Durvalumab | No | PATAPSCO | Monoclonal antibody binds PD-L1 inhibiting its interaction with PD-1 | Preliminary results not reported | Not yet reported | Not yet reported | Not yet reported |
| Nivolumab | No | CheckMate 9UT | PD-1 immune checkpoint inhibitor | Preliminary results not reported | Not yet reported | Not yet reported | Not yet reported |
| Nadofaragene Firadenovec | Yes | INSTILADRIN | Recombinant adenovirus vector and polyamide surfactant | 157 | a) 53% b) 34.2% | a) 9.7 months b) 36 months | Not Reported |
| CG0070 | No | CORE1 | Modified adenovirus that induces cell lysis paired with anti PD-1 therapy | 35 | a) 88% b) 73% |
a) 3 months b) 12 months |
Not Reported |
| TARA-002 | No | ADVANCED-1 | Lyophilized mixture of low-virulence Streptococcus pyogenes cells treated with benzylpenicillin | 102 | Not reported | Not yet Reported | Not yet reported |
| Gemcitabine & Docetaxel | No | Retrospective Review | Combination intravesical therapy | 276 | a) 60% b) 46% |
a) 12 months b) 24 months | Not Reported |
| Cabazitaxel, Gemcitabine, Cisplatin | No | Phase 2 trial | Combination intravesical therapy | Preliminary results not reported | Not yet reported | Not yet reported | Not yet reported |
| Electromotive Drug Administration | No | Prospective Trial | Intravesical chemotherapy with mild electric current to enhance penetration | 26 | a) 44% b) 30.4% | a) 12 months b) 18 months | Not Reported |
| Hyperthermic Intravesical Chemotherapy | No | Retrospective Review | Heated intravesical therapy | 56 | a) 53% b) 35% | a) 12 months b) 24 months | Not Reported |
| TAR-200 | No | SUNRISE-1 and SUNRISE-2 | Investigational drug delivery system; controlled, continuous dose of gemcitabine or cetrelimab | 23 | Not yet reported | Not yet reported | Not yet reported |