Relay Therapeutics reports 88% interim ORR for RLY-4008 in FGFR2-fusion CCA at pivotal dose

Relay Therapeutics, Inc.

15 of 17 efficacy-evaluable patients at 70 mg QD achieved partial response (88% interim ORR); 14 confirmed, 1 unconfirmed.
13 of 15 responders remain on treatment; one patient resected with curative intent; two stable disease patients continue.
Across all doses/schedules, 24 of 38 FGFRi-naïve FGFR2-fusion CCA patients had partial response (63% interim ORR).
No Grade 4 or 5 adverse events; off-target toxicities (hyperphosphatemia, diarrhea) clinically insignificant.
Pivotal cohort enrollment expected to complete in H2 2023; initial non-CCA data and full dose escalation data expected in 2023.

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