Diffuse large B cell lymphoma
ADCTADC TherapeuticsCatalyst overview
Research summary
This catalyst tracks a Phase 3 data readout for ZYNLONTA (Loncastuximab Tesirine) + rituximab in Diffuse large B cell lymphoma. The expected timing is based on the latest available company guidance and may change.
LOTIS-5 study (Lonca-R). ZYNLONTA was approved on 4/23/2021. 12/30/24- Completed enrollment of LOTIS-5 study (Phase 3 confirmatory trial). Topline data by end of 2025. 11/10/25:- LOTIS-5 topline PFS data now expected H1 2026; sBLA and confirmatory approval targeted by H1 2027. 03/10/26:- LOTIS-5 Phase 3 topline PFS results expected in Q2 2026; full LOTIS-5 data by year-end 2026. 05/04/26:- LOTIS-5 topline still expected Q2 2026; full data and sBLA submission targeted by YE 2026; compendia H1 2027. 06/03/26:- LOTIS-5 met PFS. Pre-sBLA FDA meeting August 2026; sBLA submission Q4 2026. 08/13/26:- LOTIS-5 pre-sBLA meeting raised benefit-risk concerns. Full data will be presented at ASH by YE 2026; regulatory timing is under assessment.
Verification
Confirm timing and program details against the company announcement or filing.