IDEAYA prepares Phase 3 IDE849 lung cancer trial

• IDEAYA Biosciences received FDA guidance supporting the design of a global Phase 3 trial for IDE849 in extensive stage small cell lung cancer.
• The planned study will enroll about 400 patients comparing IDE849 with investigator’s choice treatments.
• IDEAYA expects to begin the Phase 3 trial by year-end 2026 while continuing dose selection and combination studies.

IDEAYA Biosciences (NASDAQ:IDYA) reported that an FDA Type C meeting provided guidance for the planned global randomized Phase 3 trial of IDE849, a DLL3-targeting TOP1 antibody-drug conjugate for extensive stage small cell lung cancer.

The company plans to evaluate IDE849 in patients with extensive stage small cell lung cancer who previously received tarlatamab, with the Phase 3 program expected to begin by year-end 2026.

The planned trial will enroll approximately 400 patients randomized 1:1 to receive IDE849 monotherapy or investigator’s choice treatment with topotecan or amrubicin, with blinded independent central review ORR as the potential accelerated approval endpoint and median overall survival as the potential full approval endpoint.

IDEAYA Biosciences said ongoing Phase 1 studies are evaluating IDE849 doses of 2.4 mg/kg and 3.5 mg/kg administered intravenously every three weeks to select the recommended Phase 3 dose.

IDEAYA develops targeted cancer therapies, including antibody-drug conjugates and other precision medicine programs focused on genetically defined cancer targets.

The company is also studying IDE849 in combination with AstraZeneca’s Imfinzi and IDEAYA’s PARG inhibitor IDE161 to support potential future first-line small cell lung cancer trial designs.