IDEAYA Biosciences Announces Successful FDA Type C Meeting for IDE849, DLL3 TOP1 ADC, on Phase 3 Registrational Trial Design for Potential Accelerated and Full Approval in Extensive Stage Small Cell Lung Cancer

IDEAYA Biosciences Announces Successful FDA Type C Meeting for IDE849, DLL3 TOP1 ADC, on Phase 3 Registrational Trial Design for Potential Accelerated and Full Approval in Extensive Stage Small Cell Lung Cancer

PR Newswire

SOUTH SAN FRANCISCO, Calif., Aug. 31, 2026

Based on FDA Type C meeting, targeting to initiate a randomized Phase 3 registrational trial for IDE849 monotherapy by year-end 2026 in ES-SCLC, with ORR by BICR as the primary endpoint for potential accelerated approval and median OS as the primary endpoint for potential full approvalDose evaluation ongoing of 2.4mg/kg and 3.5 mg/kg IV Q3W to determine the RP3DTarget enrollment for the Phase 3 study will be ~400 ES-SCLC patients, randomized 1:1 treatment vs. investigator's choiceClinical data updates for IDE849 in 100 ES-SCLC and NEC patients by partner Hengrui at ESMO 2026 and the IDEAYA sponsored Phase 1/2 clinical trial in ES-SCLC and NEC in Q4 2026 to support a potential best-in-class profileIDE849 is being evaluated in clinical combinations with PDL1 and IDEAYA's PARG inhibitor IDE161 to determine a potential 1L SCLC Phase 3 registrational trial designSOUTH SAN FRANCISCO, Calif., Aug. 31, 2026 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, announced a successful FDA Type C meeting to determine the Phase 3 registrational trial design for IDE849, a potential best-in-class delta-like ligand 3 (DLL3)-targeting Topo-I-payload antibody drug conjugate (ADC), in extensive stage small cell lung cancer (ES-SCLC). IDEAYA is targeting to initiate the Phase 3 registrational study in ES-SCLC by year-end 2026.