IDE849 (SHR-4849) DLL3 TOP1 ADC Updated Phase 1 Results at ESMO 2026 Demonstrates Promising Anti-Tumor Activity and Preliminary Overall Survival Results in Relapsed Small Cell Lung Cancer and Neuroendocrine Carcinomas
Key Highlights
- ➤IDE849 delivered 17.4-month median OS in second-line SCLC (n=51)
- ➤Second-line SCLC ORR reached 72.5%, with 6.9-month median PFS
- ➤SCLC brain metastases achieved 76.9% ORR and 65.4% confirmed ORR
- ➤Other NECs posted 52.6% ORR, 7.0-month median PFS, and 82.4% nine-month OS
- ➤IDEAYA targets two Phase 3 trials in ES-SCLC and NEC following FDA Type C meetings
Expert Statements
Yujiro S. Hata, Chief Executive Officer and Chairman, IDEAYA Biosciences, Inc.
“We are highly encouraged by the first-reported preliminary median overall survival and 9-month landmark OS results observed for IDE849 monotherapy in both relapsed SCLC and NEC, respectively. We look forward to advancing IDE849 globally with our partner Hengrui, as we target to advance registrational studies in the high unmet medical need indications of SCLC and NEC. IDEAYA also looks forward to providing the first efficacy and safety update from our global clinical study of IDE849 monotherapy, including in the post-Imdelltra SCLC and relapsed NEC settings.”
IDE849 (SHR-4849) DLL3 TOP1 ADC Updated Phase 1 Results at ESMO 2026 Demonstrates Promising Anti-Tumor Activity and Preliminary Overall Survival Results in Relapsed Small Cell Lung Cancer and Neuroendocrine Carcinomas PR Newswire
* 17.4-month median OS in 2L SCLC (n=51) and 14.7-month median OS in 2L + ≥3L SCLC (n=101) * 72.5% (37/51) ORR and 60.8% (31/51) cORR in 2L SCLC with 6.9-month median PFS; 68.3% (69/101) ORR and 54.5% (55/101) cORR in 2L + ≥3L SCLC with 6.8-month median PFS * 76.9% (20/26) ORR and 65.4% (17/26) cORR in SCLC patients with brain metastases * Efficacy observed in NECs, with 52.6% (10/19) ORR, 36.8% (7/19) cORR, 7.0-month median PFS and an 82.4% nine-month OS rate * Grade ≥3 TRAE of 33.3% at the 2.4 mg/kg expansion dose. 2.5% treatment-related discontinuation rate and 0.8% Grade ≥3 ILD rate observed across the study (n=122) * In IDEAYA's separate IDE849 global clinical study at the 2.4 mg/kg and 3.5 mg/kg expansion doses a Grade ≥3 TRAE rate of 5% (1/20) and 22.2% (4/18) have been observed, respectively * Following successful Type C meetings with the U.S. FDA, IDEAYA is targeting to initiate two Phase 3 registrational trials with IDE849 in ES-SCLC and NEC. Evaluation of a potential 1L ES-SCLC Phase 3 study design is ongoing with continued data generation from several clinical combinations SOUTH SAN FRANCISCO, Calif., Oct. 23, 2026 /PRNewswire/ -- IDEAYA Biosciences, Inc. (Nasdaq: IDYA) today announced updated clinical results that show promising anti-tumor activity and preliminary overall survival results for IDE849 (SHR-4849), its investigational antibody-drug conjugate (ADC) directed against delta-like ligand 3 (DLL3) and carrying a topoisomerase I (TOP1) inhibitor payload. IDEAYA's partner, Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Hengrui), is presenting the results from its Phase 1 study in China in relapsed small cell lung cancer (SCLC) and other neuroendocrine carcinomas (NECs) at the European Society for Medical Oncology (ESMO) Congress 2026.
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