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IDEAYA's IDE849 Demonstrates Strong DLL3 Activity in SCLC and NECs with OS Signals

Oct 23, 2026, 6:27 AM EDT1 sourcesAI-analyzed

Why it may matterVerify against the original reporting

Positive efficacy signals (high ORR across SCLC, strong 2L OS, brain metastases activity) and imminent Phase 3 catalysts could re-rate IDYA on progress toward registrational trials; execution risk remains until Phase 3 results are reported.

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ESMO 2026 updates for IDE849 (DLL3 ADC) show robust anti-tumor activity in relapsed SCLC and NEC, including 2L OS of 17.4 months and 2L+≥3L OS of 14.7 months. Intracranial activity is suggested by a 76.9% ORR in brain metastases, with manageable safety. Following successful FDA Type C interactions, IDEAYA targets two Phase 3 registrational trials in ES-SCLC and NEC, potentially accelerating its path to market.

IDE849 shows strong SCLC activity: ORR 68.3%, cORR 54.5% (n=101).
2L SCLC OS 17.4 months; all-lines OS 14.7 months; PFS ~6.8–6.9 months.
Brain metastases: ORR 76.9%, cORR 65.4%; NECs: ORR 52.6%.
Safety: Grade ≥3 TRAEs 33.3% at 2.4 mg/kg; plan for two Phase 3 trials.

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