Relay Therapeutics Advances Towards Pivotal Trial with Promising Breast Cancer Data, Setting Stage for Competition with AstraZeneca’s Truqap

Pivotal Trial Plans:
Relay Therapeutics is moving forward with a pivotal study of RLY-2608, an experimental treatment for heavily pretreated locally advanced or metastatic breast cancer with PI3Kα mutations, set to start in 2025.

Clinical Data:
Initial clinical data for RLY-2608 demonstrated selective target engagement at multiple predicted efficacious doses with a favorable initial safety and tolerability profile. No Grade 3 hyperglycemia, rash, or diarrhea were observed at target exposures, and a confirmed partial response was seen in a breast cancer patient with 12 prior lines of therapy.

Competition with AstraZeneca:
The upcoming pivotal trial positions RLY-2608 to compete with AstraZeneca's Truqap, highlighting the potential for RLY-2608 to transform treatment for patients with PI3Kα mutations.

Regulatory Pathway:
Relay Therapeutics has engaged with the FDA regarding the regulatory pathway for RLY-2608 and plans to submit a new drug application (NDA) based on further data and extended follow-up.

Financial Position:
As of the second quarter of 2024, Relay Therapeutics reported cash, cash equivalents, and investments totaling approximately $688 million, which is anticipated to support its operational plans through the latter half of 2026.