Zynlonta loncastuximab tesirine APPROVED
Drug Profile
ModalityAntibody-drug conjugate
RouteIV
Therapy AreaHematology
Launch2021-04-23
Peak Sales Est$1000M
Formulations[{"id":"zynlonta-iv","doses":"0.15 mg/kg Q3W for 2 cycles, then 0.075 mg/kg Q3W","route":"IV","devic
Companies
SOBI (LICENSEE)50%
Mechanism: Anti-CD19 antibody-drug conjugate
Expert: CD19-directed antibody conjugated to a pyrrolobenzodiazepine (PBD) dimer cytotoxin via a cleavable linker. Upon binding CD19 on B-cell malignancies, the ADC is internalized and the PBD dimer crosslinks DNA in the minor groove, inducing cell death. PBD dimers are ~100-1000x more cytotoxic than MMAE/DM1 payloads used in other ADCs.
Everyday: A guided missile for blood cancer. An antibody finds and locks onto CD19 (a marker on B-cell lymphoma cells), then delivers a potent cell-killing toxin (PBD dimer) directly inside the cancer cell. Like attaching a bomb to a homing beacon — the antibody does the targeting, the toxin does the killing. Only cancer cells with CD19 get destroyed.
Targets: []
Revenue History
PeriodRevenue ($M)
2024$95M
Programs (2)
IndicationStageKey StudyRegional Status
R/R DLBCL 3L+APPROVEDLOTIS-2[{"notes":"Accelerated approval. LOTIS-5 confirmatory required.","stage":"APPROV
R/R DLBCL 2L (Zynlonta+R)PHASE3LOTIS-5[]
Clinical Studies (2)
LOTIS-5 PHASE3
ACTIVE · n=350
Primary EP: [{"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
LOTIS-2 PHASE2
COMPLETED · n=145
Primary EP: [{"id":"lotis2-ep1","name":"Overall response rate (ORR)","type":"PRIMARY","unit":"%","results":[{"ci":"39.9-56.7","arm":"lotis2-lonca","label":"48.3% (70/145)","value":48.3}],"description":"Proportion
Safety: GGT increase 41.4% (17.2% Gr>=3). Neutropenia 40% (26.2% Gr>=3). Thrombocytopenia 33.1% (17.9% Gr>=3). Edema/effusion composite 31% (Gr3 edema 3%, Gr3 pleural effusion 3%). Liver enzyme abnormalities
NCT03589469
Upcoming Catalysts (1)
Zynlonta - R/R DLBCL 2L - Ph3 - Data (LOTIS-5) H1/H2 2026
Notes
Anti-CD19 ADC with PBD dimer payload for R/R DLBCL. Accelerated FDA approval Apr 2021 (3L+). KEY RISK: LOTIS-5 confirmatory Phase 3 data expected end 2025/early 2026 — if negative, accelerated approval at risk. LOTIS-5 tests Zynlonta+rituximab vs R-GemOx in 2L+ R/R DLBCL. Safety run-in: ORR 80%, CR 50%, mPFS 8.31 months. ADC Therapeutics is development partner. Competitive landscape increasingly crowded: bispecifics (epcoritamab, glofitamab), CAR-T (Yescarta, Breyanzi), and Polivy (ADC).
Data from Supabase · Updated 2026-03-24