Relay reports positive interim RLY-2608 data: 9.2mo PFS in PI3Kα-mutated breast cancer

Relay Therapeutics, Inc.

Median PFS 9.2 months (all mutations) and 10.3 months (kinase mutations) at RP2D in heavily pre-treated patients without PTEN/AKT co-mutations.
ORR of 33% overall and 53% in kinase mutations; CBR 57%; tumor reductions in 73% of measurable patients.
Favorable tolerability: 95% median dose intensity, only 2 discontinuations due to TRAEs, 1 Grade 3 hyperglycemia, no Grade 4-5 TRAEs.
Lirafugratinib: FDA suggests file NDA in cholangiocarcinoma first, then tumor-agnostic sNDA; company seeks global partner.
Cash runway ~$688M into H2 2026; plan to initiate 2L pivotal study of RLY-2608 in 2025.

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