ADC Therapeutics: LOTIS-5 Phase 3 meets PFS endpoint; sBLA submission planned Q4 2026

ADC Therapeutics SA

PFS HR=0.73 (p=0.008); median PFS 6.1 mo ZYNLONTA+ritux vs 4.7 mo R-GemOx.
ORR 58.1% vs 45.2%; CR 39.5% vs 26.7%; median DoCR 16.8 vs 12.3 mo.
Grade 5 TEAEs higher in test arm (13.2% vs 4.6%); majority in patients ≥75 years.
Plans pre-sBLA meeting with FDA in August; sBLA submission expected Q4 2026.
Company will evaluate value-maximizing alternatives, including cost reduction initiatives.

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