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Molecular Profile FGFR3 S249C
Therapy Pemigatinib
Indication/Tumor Type transitional cell carcinoma
Response Type predicted - sensitive

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
FGFR3 S249C transitional cell carcinoma predicted - sensitive Pemigatinib Case Reports/Case Series Actionable In a Phase I trial (FIGHT-101), Pemazyre (pemigatinib) treatment led to a partial response in a urothelial cancer patient harboring FGFR3 S249C (PMID: 35176457; NCT02393248). 35176457
FGFR3 S249C transitional cell carcinoma predicted - sensitive Pemigatinib Phase II Actionable In a Phase II trial (FIGHT-201), Pemazyre (pemigatinib) treatment resulted in an objective response rate (ORR) of 17.9% with continuous dosing and 24.2% with intermittent dosing in patients with urothelial carcinoma harboring FGFR3 mutations, with an ORR in patients harboring FGFR3 S249C of 23.9% with continuous dosing (n=46) and 24.6% with intermittent dosing (n=61) (PMID: 37956738; NCT02872714). 37956738
FGFR3 S249C transitional cell carcinoma predicted - sensitive Pemigatinib Case Reports/Case Series Actionable In a clinical case study, Pemazyre (pemigatinib) treatment resulted in a partial response with a progression-free survival of 8.3 months in a patient with urothelial cancer harboring FGFR3 S249C (PMID: 37377403). 37377403
PubMed Id Reference Title Details
(35176457) FIGHT-101, a first-in-human study of potent and selective FGFR 1-3 inhibitor pemigatinib in pan-cancer patients with FGF/FGFR alterations and advanced malignancies. Full reference...
(37377403) Resistance to selective FGFR inhibitors in FGFR-driven urothelial cancer. Full reference...
(37956738) Pemigatinib for Metastatic or Surgically Unresectable Urothelial Carcinoma With FGF/FGFR Genomic Alterations: Final Results From FIGHT-201. Full reference...