IDEAYA reports positive Phase 1 IDE849 data and plans two Phase 3 trials
+1 new source since this summary was written
IDEAYA Biosciences reported updated Phase 1 data for IDE849, an investigational DLL3-targeting ADC, at ESMO 2026 on October 23, 2026. In second-line SCLC, the study recorded median overall survival of 17.4 months and median progression-free survival of 6.9 months; across previously treated SCLC, the corresponding figures were 14.7 months and 6.8 months. IDEAYA said it is targeting two Phase 3 registrational studies in extensive-stage SCLC and NEC after successful Type C meetings with the FDA.
Why it matters
The results provide additional clinical data for IDEAYA's lead partnered drug candidate in SCLC and NEC, while the planned Phase 3 program would move IDE849 toward registrational testing. The company expects to advance the program globally with Jiangsu Hengrui Pharmaceuticals, subject to the planned regulatory process.
Key facts
- 1The 2L SCLC cohort had a 72.5% ORR and a 60.8% cORR, with 51 patients evaluated. prnewswire.com
- 2Across 2L and later-line SCLC, ORR was 68.3% and cORR was 54.5% in 101 patients. prnewswire.com
- 3For patients with other NECs, ORR reached 52.6%, cORR reached 36.8%, median PFS was 7.0 months, and the nine-month OS rate was 82.4%. prnewswire.com
- 4At the 2.4 mg/kg expansion dose, Grade ≥3 treatment-related adverse events occurred in 33.3% of patients. prnewswire.com
- 5Across the study, treatment-related discontinuation occurred in 2.5% of patients and Grade ≥3 ILD occurred in 0.8% of patients. prnewswire.com
- 6IDEAYA's separate global study recorded Grade ≥3 treatment-related adverse-event rates of 5% at 2.4 mg/kg and 22.2% at 3.5 mg/kg. prnewswire.com
Summary written by AlphAI AI Desk from 2 of 2 sources. Not investment advice. Figures are as stated by the linked sources.