ADC Therapeutics SA filed SEC Form 8-K: Other Events
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Item 8.01. Other Events.
On December 3, 2025, ADC Therapeutics SA (the “Company”) announced updated data from the ongoing LOTIS-7 Phase 1b open-label clinical trial evaluating the safety and efficacy of ZYNLONTA® in combination with the bispecific antibody glofitamab (COLUMVI®) in patients with relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL).
As of the November 17, 2025 cutoff date, a total of 49 patients were efficacy evaluable with a minimum of 6 months of follow-up from treatment initiation. Key highlights of the data are as follows:
| · | Best overall response rate (ORR) was 89.8% (44/49 patients), as assessed by Lugano criteria |
| o | ORR was 95.2% at the 120 µg/kg dose and was 85.7% at the selected 150 µg/kg dose |
| · | Complete response (CR) rate was 77.6% (38/49 patients) |
| o | Of these, 33/38 patients achieving CR remain in CR as of the data cutoff; the 5 patients who did not remain in CR included 2 patients with progressive disease, 2 patients with Grade 5 AEs which occurred during CR, and one censored patient |
| o | CR rate was 81.0% at the 120 µg/kg dose and was 75.0% at the selected 150 µg/kg dose |
| · | Strong efficacy in both the relapsed and primary refractory populations across both dose levels |
| o | In the 24 relapsed patients, ORR was 100% and CR rate was 91.7% |
| o | In the 25 primary refractory patients, ORR was 80% and CR rate was 64% |
| · | 14 patients converted from stable disease (SD) or partial response (PR) to CR over time (1 and 13 patients, respectively) |
| · | Of the 8 patients previously treated with CAR-T, 6 achieved a CR |
| · | The combination was generally well tolerated with a manageable safety profile |
| o | Grade 3 or higher treatment emergent adverse events (TEAEs) observed in > 5% of patients included neutropenia (32.7%), GGT increased (16.3%), anemia (10.2%), WBC decreased (8.2%), generalized oedema (8.2%), ALT increased (8.2%), AST increased (6.1%), and thrombocytopenia (6.1%) |
| o | Grade 5 AEs occurred in 2 (4.1%) patients, one at each dose level; the one at the 120 µg/kg dose was treatment-related per the investigator |
| o | Cytokine release syndrome (CRS) of all grades across dose levels was 36.7% |
| § | CRS all grades was 25.0% at the selected 150 µg/kg dose and 52.4% at the 120 µg/kg dose, with all but one were low Grade |
| o | Immune effector cell-associated neurotoxicity syndrome (ICANS) was 4.1% across dose levels, with only Grade 1/2 |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| ADC Therapeutics SA | ||
| Date: December 5, 2025 | ||
| By: | /s/ Ameet Mallik | |
| Name: | Ameet Mallik | |
| Title: | Chief Executive Officer | |