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Trial Information

Molecule Overview

FGFR3 Inhibitor

LOXO-435

Type of Alteration(s)

Point mutations^*

Alteration(s) of Interest ^†

FGFR3 R248C
FGFR3 S249C
FGFR3 G370C
FGFR3 Y373C

Methodology

Key Considerations

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NGS (Tissue)

Suitable for broad-based genomic profiling that includes targets in addition to FGFR3
Full coverage of FGFR3 gene is preferred over hotspot sequencing

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NGS (cfDNA)

Useful when tissue biopsy sample is limited/unavailable
Higher false negative rate than tissue-based NGS testing

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PCR-based

Will detect selected mutations

*

Point mutations occur at higher frequency (15-20%) than fusions (2-3%)

†

List not exhaustive of all activating alterations

References

Robertson AG, et al. Cell. 2017;171(3):540-556.
TCGA Research Network. Nature. 2014;507(7492):315-322.
Nassar AH, et al. JCO Precis Oncol. 2018;2:PO.18.00013.

Type of Alteration(s)

Gene fusions^*

Alteration(s) of Interest ^†

FGFR3-TACC3

Methodology

Key Considerations

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NGS (Tissue)

Suitable for broad-based genomic profiling that includes targets in addition to FGFR3
Full coverage of FGFR3 gene is preferred over hotspot sequencing
Assay should minimally cover exons 17 and 18 to ensure detection of most common fusions
RNA-based NGS is most suitable for fusions

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NGS (cfDNA)

Useful when tissue biopsy sample is limited/unavailable
Higher false negative rate than tissue-based NGS testing

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PCR-based

Will detect known fusions but may miss novel FGFR3 rearrangements

*

Point mutations occur at higher frequency (15-20%) than fusions (2-3%)

†

List not exhaustive of all activating alterations

References

Robertson et al. Cell 2017;171(3):540-556
TCGA Research Network Nature 2014;507(7492):315-322
Nassar et al. JCO Precis Oncol 2018;16(2)

Type of Alteration(s)

Amplification/Overexpression

Alteration(s) of Interest

FGFR3 gene, FGFR3 mRNA, FGFR3 protein or its ligands

Methodology

Key Considerations

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IHC

Directly measures FGFR3 protein expression
Provides spatial information
Short TAT
Requires pathologist training or central testing

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RNA-ISH

Detects FGFR3 mRNA overexpression
Short TAT
Requires pathologist training or central testing

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NGS (Tissue)

Detects FGFR3 mRNA overexpression
Short TAT
Requires pathologist training or central testing

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PCR-based

Detects FGFR3 mRNA overexpression
Sensitive
Does not provide spatial information

References

Ellinghaus P et al. Cells. 2022;11(19):3180

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