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IDEAYA Biosciences and Hengrui Pharma Present Positive Phase 1 Data for IDE849 (SHR-4849), a Potential First-in-Class DLL3 TOP1 ADC, in Small Cell Lung Cancer at the IASLC 2025 World Conference on Lung Cancer
Prnewswireยท2025-09-07 16:00

Core Insights - IDEAYA Biosciences and Hengrui Pharma presented initial data from Hengrui's Phase 1 clinical trial of IDE849, a DLL3-targeting TOP1 antibody drug conjugate, at the IASLC 2025 World Conference on Lung Cancer [1][2] Efficacy Data - The trial included 100 patients, with 87 having small-cell lung cancer (SCLC) and 13 with other neuroendocrine carcinomas (NEC) [2] - In the expansion phase, 71 evaluable SCLC patients showed an overall response rate (ORR) of 73.2% across all lines of therapy [3][4] - At the 2.4 mg/kg dose, the ORR was 80.0% in 2L SCLC and 73.7% across all lines of SCLC [4][10] - A median progression-free survival (PFS) of 6.7 months was observed across all lines of SCLC [10] Safety Profile - Among 100 patients treated, 48% experienced Grade 3 or higher treatment-related adverse events (TRAEs) [10] - The most common TRAEs included neutropenia (33% Gr>3) and white blood cell reduction (27% Gr>3) [10] - The treatment-related discontinuation rate was 2%, with no treatment-related deaths reported [10] Collaboration and Future Development - Hengrui Pharma granted IDEAYA an exclusive worldwide license to develop and commercialize IDE849 outside of Greater China [7] - IDEAYA aims to advance the global clinical development of IDE849 for SCLC, NETs, and other DLL3 upregulated solid tumors [2][7]