#ESMO2026 abstract: 🇨🇳Innovent’s IBI363 + Chemotherapy (PDC) Shows mPFS Not Reached in 1L NSCLC (1044P) Study design - 80 previously untreated patients with advanced NSCLC without actionable EGFR, ALK or ROS1 alterations were enrolled. - In the dose-optimization stage, patients with PD-L1 TPS <50% were randomized to IBI363 at 1.5 mg/kg or 3 mg/kg every three weeks (Q3W), or 3 mg/kg in Cycle 1 followed by 1.5 mg/kg Q3W, each combined with PDC. - Data cutoff: April 7, 2026. median follow-up of 8.9 months Key efficacy results - 1.5 mg/kg Q3W, cORR: 47.4% (n=19), mPFS: 7.0 months - 3 mg/kg Q3W, cORR: 61.9% (n=21), mPFS: 8.5 months - 3→1.5 mg/kg Q3W, cORR: 86.4% (n=22), mPFS: Not reached in both non-squamous and squamous NSCLC subgroups Safety - Grade ≥3 treatment-emergent adverse events occurred in 85.0% of patients overall. 89.3% (1.5 mg/kg), 93.1% (3 mg/kg), and 69.6% (3→1.5 mg/kg). - IBI363-related adverse events led to treatment discontinuation in 8 patients (10.0%) and death in 2 patients (2.5%). - No new safety signals were reported.
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Source: chuminhua432 · x.com
