Complete Announced during: After hours · announced Wed 4:17p ET (after hours); before = Wed close; first trade Wed 4:18p ET; time = SEC 8-K acceptance
ADC Therapeutics SA (NYSE: ADCT) reported topline results from a Phase 3 trial of ZYNLONTA in relapsed or refractory diffuse large B-Cell lymphoma on June 3, 2026. The company said the trial met its primary endpoint. ClinicalTrials.gov lists 440 enrolled participants (NCT04384484).
Trial details
- Drug
- ZYNLONTAType Drug Route intravenous
- Treats
- Studied as a treatment for relapsed or refractory diffuse large B-Cell lymphoma (registry condition: Relapsed Diffuse Large B-Cell Lymphoma, Refractory Diffuse Large B-Cell Lymphoma).Conditions Relapsed Diffuse Large B-Cell Lymphoma, Refractory Diffuse Large B-Cell Lymphoma
- Patients
- 440 patients (actual enrollment)3 arms · 144 sites in 21 countries
- Phase
- Phase 3
- Design
- Randomized, open-label, parallel-group
- Primary endpoint
- Progression-free Survival (PFS) (Up to 4 years)
- Key secondary endpoints
- Overall Survival (OS)
- Overall Response Rate (ORR)
- Complete Response Rate (CRR)
- Result
- Met endpointThe study met the primary endpoint of PFS (per independent review committee) with statistical significance (HR = 0.73; p-value = 0.008 two sided), with a median PFS of 6.1 months for ZYNLONTA plus rituximab vs 4.7 months for R-GemOx.
- Safety
- Overall, treatment emergent adverse event (TEAE) rates were similar between arms.
- Sponsor
- ADC Therapeutics SA NYSE: ADCT
- Dates
- Study start Sep 16, 2020Primary completion Mar 31, 2026Announced Jun 3, 2026, 4:17 PM ET (SEC 8-K filing time)
- Trial ID
- NCT04384484 ClinicalTrials.gov
About this trial
This randomized, open-label, parallel-group Phase 3 trial (NCT04384484) tested ZYNLONTA in Relapsed Diffuse Large B-Cell Lymphoma and Refractory Diffuse Large B-Cell Lymphoma. Studied as a treatment for relapsed or refractory diffuse large B-Cell lymphoma (registry condition: Relapsed Diffuse Large B-Cell Lymphoma, Refractory Diffuse Large B-Cell Lymphoma). It enrolled 440 patients across 3 arms at 144 sites in 21 countries. The primary endpoint was Progression-free Survival (PFS) (Up to 4 years). ADC Therapeutics SA reported that the trial met its primary endpoint. The study started on Sep 16, 2020 and reached primary completion on Mar 31, 2026.
Sources
- Source: SEC EDGAR 8-K (EX-99.1)
- ClinicalTrials.gov record: NCT04384484
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