# LOTIS-2

Source: https://onco.cc/trials/lotis-2/  
OnCo record `lotis-2` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

LOTIS-2 was the pivotal study for loncastuximab, a CD19 ADC with a DNA-crosslinking payload.

## Summary

LOTIS-2, trial NCT03589469 sponsored by ADC Therapeutics and reported in 2021, was the pivotal single-arm study for loncastuximab tesirine, a CD19 antibody-drug conjugate with a DNA-crosslinking pyrrolobenzodiazepine payload, in relapsed or refractory diffuse large B-cell lymphoma after at least two lines. In 145 patients the objective response rate was 48 percent with complete responses in 24 percent and durable responses, while oedema, effusions, photosensitivity and liver enzyme rises are class effects of the payload. OnCo links it to lymphoma and loncastuximab tesirine. The confirmatory LOTIS-5 trial of loncastuximab with rituximab against rituximab-gemcitabine-oxaliplatin will show whether the drug improves on chemotherapy, which is the open question.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-07
- Registry id: NCT03589469
- Phase: 2
- Setting: R/R DLBCL after ≥2 lines: loncastuximab tesirine (single arm)
- Sponsor: ADC Therapeutics
- Enrolled: 145
- Result: ORR 48%, CR 24%.
- Outcomes: Objective response rate: Loncastuximab tesirine 48.3%

## Sources

- ClinicalTrials.gov NCT03589469: https://clinicaltrials.gov/study/NCT03589469

## Connected records

- cancers: [Diffuse large B-cell lymphoma](https://onco.cc/cancers/dlbcl/)
- technologies: [Antibody-drug conjugate (ADC)](https://onco.cc/technologies/adc/)
- drugs: [Loncastuximab tesirine](https://onco.cc/drugs/zynlonta/)

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JSON: https://onco.cc/api/v1/entities/lotis-2.json