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Association details:
| Biomarker: | FGFR2 rearrangement |
|---|---|
| Cancer: | Cholangiocarcinoma |
| Drug: | lirafugratinib (RLY-4008) (FGFR2 inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Updated dose escalation results for ReFocus, a first-in-human study of highly selective FGFR2 inhibitor RLY-4008 in cholangiocarcinoma and other solid tumors.
Published date:
05/25/2023
Excerpt:
Anti-tumor activity was observed in CCA and solid tumors across doses and FGFR2 alterations with radiographic tumor reductions in 74 (64%), SD/PR in 83 (72%)...Clinically meaningful disease control and durable responses were observed in pts with FGFR2 f/r CCA....These encouraging dose escalation data confirm the broad therapeutic potential of highly selective FGFR2 targeting with RLY-4008 by demonstrating encouraging initial efficacy across FGFR2-altered solid tumors and genomic alterations, with a differentiated safety profile that avoids FGFR1- and FGFR4-related toxicity.
DOI:
10.1200/JCO.2023.41.16_suppl.4009
Trial ID:
Source:
Title:
76MO - Efficacy of RLY-4008, a highly selective FGFR2 inhibitor in patients (pts) with an FGFR2-fusion or rearrangement (f/r), FGFR inhibitor (FGFRi)-naïve cholangiocarcinoma (CCA): ReFocus trial
Published date:
11/28/2022
Excerpt:
Potent efficacy was observed across all doses, particularly at the RP2D with an ORR of 88%...RLY-4008 is a promising next-generation inhibitor with potential to transform the treatment of FGFR2 f/r, FGFRi-naïve CCA.
Trial ID:
