Full Efficacy & Safety Summary Table
| Indication | Patients with relapsed advanced RCC following 2 or more prior systemic therapies (including prior CPI) |
| Registrational Trial | Full Approval. Phase 3 (n=350) vs. Sorafenib (NCT02627963) |
| Regimen | 1.34 mg taken orally once daily for 21 days on treatment followed by 7 days off treatment for a 28 day cycle, continue treatment until disease progression or until unacceptable toxicity occurs |
| Efficacy Outcomes | •mPFS: 5.6 mo vs. 3.9 mo (HR: 0.73) •2 YR PFS: 18% vs 5% (1YR PFS: 28% vs. 11%) •ORR: 18% vs 8% •mDOR: NR vs 5.7 mo, 71% responding at 12 months •Link to PFS Curve https://www.fotivdahcp.com/efficacy/pfs/ (make this a hyper link rather than including actual link) •Trial design included patients progressing on a prior CPI |
| Safety Outcomes | •Duration: 31% >1Y on treatment on tivozanib •Discontinuation: 21% vs. 30% for sorafenib •Dose Adjustement: 24% vs. 39% for sorafenib Total Gr 3/4 ARs: 67% vs. 72% for sorafenib Tivozanib Gr 3/4 ARs ≥5%: Hypertension 24%, Fatigue 13%, Decreased appetite 5% |