Relay Therapeutics Highlights Interim Data From Bile Duct Cancer Trial

  • 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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