IDEAYA reports 60.8% response rate for IDE849
Key points
- IDEAYA Biosciences reported updated Phase 1 results for IDE849 showing a 60.8% confirmed response rate in second-line small cell lung cancer patients.
- Preliminary median overall survival reached 17.4 months in the second-line group, while median progression-free survival was 6.9 months.
- IDEAYA is advancing plans for two global Phase 3 trials following FDA discussions, while additional clinical data from its separate global study are expected by late 2026 or early 2027.
IDEAYA Biosciences (NASDAQ:IDYA) reported updated Phase 1 results for IDE849, showing a 60.8% confirmed objective response rate in second-line small cell lung cancer patients.
The China-based study conducted by partner Hengrui enrolled 122 patients, with preliminary median overall survival reaching 17.4 months and median progression-free survival reaching 6.9 months in second-line disease.
In August, IDEAYA President and CEO Yujiro S. Hata said the company was targeting a randomized Phase 3 study of IDE849 following a successful FDA Type C meeting.
Across previously treated small cell lung cancer patients, median overall survival reached 14.7 months, while confirmed responses were observed in 36.8% of 19 patients with other neuroendocrine carcinomas.
IDEAYA is targeting two global Phase 3 trials following regulatory discussions and expects further efficacy and safety findings from its global development program by late 2026 or early 2027.
At the 2.4 mg/kg expansion dose, Grade 3 or higher treatment-related adverse events occurred in 33.3% of patients, while one treatment-related death was reported across the study.
IDE849 is a DLL3-targeting antibody-drug conjugate that delivers a topoisomerase I inhibitor, and IDEAYA continues evaluating its activity across small cell lung cancer and other neuroendocrine tumors.
