TEST:

FGFR-PRS test

This study demonstrates that the OmniSeq INSIGHT WTS assay is a sensitive, specific, accurate, reproducible method for transcriptomic profiling of FFPE solid tumors to support precision oncology drug development.

These data provide support for FGFR-targeted therapy use in FGFR ALT (+) HR-NMIBC and describe tumors with shared FGFR pathway-activated biology that are FGFR ALT (-) but FGFR-PRS (+). The latter suggests a broader potential patient population for FGFR-targeted therapy, which will require subsequent validation in patients treated with FGFR-targeted therapy.

Background: Interest in FGFR-targeted (FGFRi) therapies for UC or pan-tumor use is growing (ongoing clinical studies include erdafitinib (NCT05316155; NCT04172675; NCT03390504; NCT04083976), LOXO-435 (NCT05614739), and pemigatinib (NCT03914794) following accelerated approval of erdafitinib in locally advanced/metastatic (m) post-chemotherapy UC patients with FGFR2/3 (i.e., DNA mutations and fusions) alterations (ALT). FGFR-PRS (+) captured most ALT (+) tumors and an additional 2X more with similar FGFR pathway activation. FGFR-PRS (+) tumors were associated with gene enrichments for ontologies linked to FGFR3 signaling. The correlation of FGFR-PRS score with in vitro FGFRi activity provided initial utility of the signature, which is undergoing clinical evaluation in the ALAMANCE retrospective study of UC patients treated with FGFRi or other standard-of-care therapies.

"GeneCentric Therapeutics...announced today the initiation of its Alamance study, a multi-center bladder cancer study conducted in collaboration with investigators at Memorial Sloan Kettering Cancer Center and the University of Wisconsin – Madison Carbone Cancer Center....In this prospectively designed real-world evidence study, clinical response data and existing tumor samples are being collected from a multi-center cohort of approximately 250 patients with locally advanced or metastatic urothelial (bladder) cancer treated with FGFR-targeted therapy (e.g., erdafitinib) or other standards of care (e.g., anti-PD-(L)1 or platinum-based chemotherapy)."