Primary Completion Date Change

ADC Therapeutics' Zynlonta combo trial pushes primary readout to March 2027

LOTIS-7 has already shown an 89.8% response rate with Zynlonta plus glofitamab, but ADC Therapeutics pushed the Phase 1 trial's completion date again as enrollment settled at 154 patients.

ADC Therapeutics pushed the primary completion date for LOTIS-7, its Phase 1 trial combining Zynlonta with other anticancer agents in relapsed or refractory B-cell non-Hodgkin lymphoma, from October 30, 2026 to March 31, 2027, while finalizing enrollment at 154 patients and moving the trial to Active, not recruiting.

By AppliedXLJuly 17, 2026Trial NCT04970901

Executive Summary

ADC Therapeutics extended the primary completion date on its Phase 1 lymphoma combination trial for the third time since early 2025, with the newest shift landing on a March 2027 date.
One of the trial's combination arms has already reported a response rate and complete response rate in company disclosures, which changes what the delayed primary completion is now expected to confirm rather than discover.
The trial's enrollment count settled below its original target as the study closed to new patients, a change the operational model reads as within the routine band rather than a shortfall.
The combination sits in a CD19-directed field crowded with commercial CAR-T therapies and bispecific antibodies, so the value of the pending full dataset depends on whether it extends the response signal already shown in a small evaluable subset to the larger, longer-follow-up population.

The timing shift

The registry record for NCT04970901 shows the primary completion date moving from February 12, 2025 to December 19, 2025 in February 2025, then to October 30, 2026 in September 2025, and now to March 31, 2027 as of the latest update. That is a cumulative push of more than two years past the trial's originally posted 2025 target, spread across three separate registry amendments. The study also moved to Active, not recruiting status, consistent with a trial that has closed enrollment and is following its dosed patients toward the new completion window. NCT04970901

Probability of Success

Endpoint Met86%

Completes17%

Clinical Significance56%

Regulatory29%

What has already read out

The trial is not starting from zero: ADC Therapeutics has disclosed that the Zynlonta-plus-glofitamab combination arm produced an 89.8% overall response rate and a 77.6% complete response rate across 49 efficacy-evaluable patients, with 100 patients dosed at the selected 150 microgram-per-kilogram Zynlonta dose. The company has also said it plans to present full LOTIS-7 data at a medical meeting and in a publication by the end of 2026. That combination of an already-disclosed response signal and a pending fuller readout means the March 2027 primary completion date functions less as a first look and more as a confirmation point for durability, safety across the trial's other arms, and the endpoints tied to electrocardiogram, laboratory, and adverse-event monitoring that anchor the trial's nine co-primary measures. A+1

Enrollment settled, not cut

Enrollment closed at 154 patients, down from a 200-patient target carried in earlier registry entries. The operational model that tracks enrollment changes against trial design flags this move as within the routine band, since it excludes early-phase count changes of this kind from the threshold it uses to flag outlier changes. The trial's protocol-change history otherwise shows a moderate pace of registry amendments, about 2.9 per year, driven mostly by the completion-date and eligibility-criteria updates rather than by an endpoint change after completion. NCT04970901

The competitive setting

Zynlonta is approved as loncastuximab tesirine for relapsed or refractory large B-cell lymphoma after two or more prior lines of therapy, and LOTIS-7 tests it in combination with polatuzumab vedotin, glofitamab, or mosunetuzumab in the same relapsed or refractory B-cell non-Hodgkin lymphoma population, now after third-line-plus prior therapy. The CD19-directed field around it is dense: Gilead Sciences' axicabtagene ciloleucel, a CAR-T therapy, and Genmab's epcoritamab, a CD19 bispecific antibody, are both running their own Phase 3 programs in B-cell lymphomas, alongside additional CD19-directed CAR-T and bispecific programs from Merck, AstraZeneca, and Bristol-Myers Squibb's Juno Therapeutics. Across CD19-directed trials in this indication, four completed and seven terminated in Phase 1, a 64% termination rate in that phase, and seven distinct companies have logged a failure in this target-indication pairing. Against that backdrop, the value of LOTIS-7's fuller dataset is whether the response and complete-response rates already reported in the glofitamab combination arm hold up across the trial's other combination arms and longer follow-up, given a field where CAR-T and bispecific approaches are already commercially established. NCT04970901

This analysis was produced using AI-assisted reporting systems, AppliedXL data, and official public records. These systems undergo editorial review, quality checks, and regular audits by human experts. Errors may still occur, as with any automated system. Always consult the linked primary sources. Read our AI Editorial Policy.