Table 1.
Completed Clinical Trials of TV in Patients with Recurrent or Advanced Cervical Cancer
| InnovaTV 20114 | InnovaTV 20428 | ||
|---|---|---|---|
| Phase | I/II | II | |
| Setting | Advanced or metastatic solid tumors | Recurrent or advanced cervical cancer | |
| Patients enrolled | Dose escalation | Dose expansion | 101 |
| TOTAL: 27 Bladder: 2 (7%) Cervix: 2 (7%) Endometrium: 3 (11%) Esophagus: 4 (15%) NSCLC: 4 (15%) Ovary: 7 (26%) Prostate: 4 (15%) SCCHN: 1 (4%) |
TOTAL 147 Bladder: 15 (10%) Cervix: 34 (23%) Endometrium: 14 (10%) Esophagus: 15 (10%) NSCLC: 15 (10%) Ovary: 36 (24%) Prostate: 18 (12%) – |
||
| ORR (95% CI) | 26.5% (12.9–44.4) | 24% (16–33) | |
| DCR (95% CI) | – | 72% (63–81) | |
| mDOR months (95% CI) | – | 8.3 (4.2-NR) | |
| mPFS months (95% CI) | – | 4.2 (3–4.4) | |
| mOS months (95% CI) | – | 12.1 (9.6–13.9) | |
Abbreviations: ORR, objective response rate; DCR, disease control rate; mDOR, median duration of response; mPFS, median progression free survival; mOS, median overall survival.