Incyte INCB 54828-207- FGFR Basket

A Phase 2, Open-Label, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib in Participants With Previously Treated Locally Advanced/Metastatic or Surgically Unresectable Solid Tumor Malignancies Harboring Activating FGFR Mutations or Translocations (FIGHT-207)

NCT03822117

Solid Tumors: Breast, Lung (NSCLC), Colon, Prostate, Bladder, Kidney, Esophagus, Stomach (Gastric), Liver (HCC), Cervical, Endometrial, Ovarian, Skin, Head and Neck (SCCHN), Bladder, Kidney (renal cell), Pancreatic, Rectal, Brain (GBM, glioblastoma)

Stage 4

Metastatic/Palliative

Following all effecive therapy (late line)

Pemigatinib

FGFR inhibitor

Dan Vaena, MD

Incyte Corporation

Phase 2

Closed to Accrual

• Metastatic or surgically unresectable solid tumor
• Measurable disease
• Documentation of an FGFR1-3 gene mutation or translocation
• At least 1 prior line of therapy with progression
• No other therapy available likely to provide clinical benefit
• ECOG PS 0-2
• No other FGFR inhibitors within last 6 months
• No clinically significant corneal or retinal disorder
• No untreated CNS disease (except primary brain cancer)
• No additional malignancy at current time requiring active treatment
• No history of calcium or phosphate disorder or systemic mineral imbalance
• No clinically significant cardiac disease
• No active HBV/HCV
• No known HIV

• Primary
  • ORR
• Secondary
  • PFS
  • DoR
  • OS
  • Safety

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FGFR 1,2,3 mutated or FGFR 1,2,3 fusion/translocation

No