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fruquintinib+sintilimab

Phase 3

Advanced Renal Cell Carcinoma | Small molecule | Oncology |HUTCHMED (China) Limited|Last Updated: Jan 2, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLED
Total Trials1
Total Enrollment265
FDA Designations
PRIORITY_REVIEWBREAKTHROUGH_THERAPY
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05522231Efficacy and Safety of Fruquintinib in Combination With Sintilimab in Advanced Renal Cell Carcinoma (FRUSICA-2)PHASE2/PHASE3 ACTIVE NOT_RECRUITING 265Oct 1, 2022Mar 1, 2025Jan 2, 2025 -
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Study Design & Arms
Interventions
NameTypeDescription
fruquintinib+sintilimabDRUGfruquintinib, 5 mg, QD, PO, 2 weeks on/1 week off, 3 weeks/cycle; sintilimab, 200 mg, IV infusion, Q3W, 3 weeks/cycle.
axitinib / everolimusDRUGaxitinib, 5 mg, twice daily (BID), PO, 3 weeks/cycle, dose escalation will be at the investigator 's discretion based on clinical; everolimus, 10 mg, QD, PO, 3 weeks/cycle.
fruquintinibDRUGfruquintinib, 5 mg, QD, PO, 3 weeks on/ 1 week off, 4 weeks/cycle.
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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT05522231studyFirstPostDate: changed