Efficacy and Safety of Fruquintinib in Combination With Sintilimab in Advanced Renal Cell Carcinoma (FRUSICA-2)
Summary
The study consists of two parts, the first part is a randomized, open-label, active-controlled study to evaluate the efficacy and safety of fruquintinib in combination with sintilimab versus axitinib or everolimus monotherapy as second-line treatment for locally advanced or metastatic renal cell carcinoma. The second part is a fruquintinib monotherapy factorial cohort study to evaluate the efficacy and safety of fruquintinib monotherapy as for second-line treatment of locally advanced or metastatic renal cell carcinoma.
Timeline
- Start
- 2022-10-27
- Primary completion
- 2025-01
- Completion
- 2025-03
Outcome
Met primary endpoint
release “Presented FRUSICA-2 registration Phase III results at ESMO 2025 for 2L RCC, in combination with TYVYT® achieving mPFS of 22.2 months versus 6.9 months” hutch-med.com ↗
release “The study met its primary endpoint of progression free survival (“PFS”) as assessed by blinded independent central review (“BICR”).” innoventbio.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Axitinib | Small molecule | 5 mg | Oral |
| Comparator | Everolimus | Small molecule | 10 mg | Oral |
| Subject | Fruquintinib | Small molecule | 5 mg | Oral |
| Subject | Sintilimab | Monoclonal antibody | 200 mg | Intravenous |