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LOTIS-5 PHASE3 ACTIVE n=350
Drug: Zynlonta · SOBI
Study Design
DesignRandomized, active-controlled
Enrollment350
Treatment Arms
Loncastuximab + Rituximab Zynlonta + rituximab combination n=175
Investigator choice immunochemotherapy Standard immunochemotherapy regimens n=175
Primary Endpoints
[{"id":"lotis5-ep1","name":"PFS or OS (event-driven)","type":"PRIMARY","results":[],"description":"Confirmatory Phase 3 for maintained approval. Safety run-in data encouraging: ORR 80%, CR 50%, median PFS 8.31 months."}]
Assessment
LOTIS-5 confirmatory data needed to maintain accelerated FDA approval. Safety run-in data (80% ORR, 50% CR, 8.31mo PFS) is encouraging. Failure risks approval withdrawal. Success expands to 2L DLBCL.
Background & Context
Confirmatory trial for accelerated approval. Lonca+R combination in R/R DLBCL 2L. Enrollment complete.
Data from Supabase · Updated 2026-03-24