- Relay Therapeutics Inc RLAY has announced an interim data Phase 1 trial of RLY-4008 in FGFR2-altered cholangiocarcinoma (bile duct cancer) and multiple other solid tumors.
- The data were shared at the AACR-NCI-EORTC Molecular Targets Conference.
- Initial efficacy data showed activity in FGFRi naïve cholangiocarcinoma FGFR2 fusion patients, with confirmed partial responses in 3/6 patients with deep tumor regressions (-56% to -83%).
- Radiographic tumor shrinkage and complete clearance of circulating tumor DNA (ctDNA) were seen in 70% of patients with acquired resistance mutations (N=10).
- Early signs of activity were observed outside of FGFR2-fusion-positive cholangiocarcinoma, including tumor reduction in 6 out of 8 evaluable patients with activating mutations.
- Approximately 80% of all patients treated achieved radiographic tumor regressions.
- RLY-4008 has generally been well-tolerated in the 49 patients treated.
- The once-daily schedule has been prioritized due to its preferable tolerability observed across all dose levels.
- Across all once-daily doses, only 16% of patients experienced mild or moderate hyperphosphatemia (elevated phosphate level in the blood).
- Relay Therapeutics anticipates selecting a recommended dose of Phase 2 and initiating expansion cohorts by the end of 2021.
- Price Action: RLAY stock closed at $26 on Thursday.
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