Press release
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ADC Therapeutics Announces Updated Data from LOTIS-7Clinical Trial Presented at the European HematologyAssociation 2025 Congress JUNE 12, 2025 LAUSANNE, Switzerland, June 12, 2025 /PRNewswire/ -- ADC Therapeutics SA (NYSE: ADCT), a commercial-stage global leader and pioneer in the eld of antibody drug conjugates (ADCs), today announced updated data from the LOTIS-7 Phase 1b open-label clinical trial evaluating the safety and e cacy of ZYNLONTA in combination with the bispeci c antibody glo tamab (COLUMVI) in patients with relapsed or refractory di use large B-cell lymphoma (r/r DLBCL) to be presented at the European Hematology Association 2025 Congress (EHA2025) in Milan, Italy. The Company will host a conference call and webcast featuring LOTIS-7 trial principal investigator and EHA presenting author, Juan Alderuccio, MD, Clinical Site Disease Group Leader, Lymphoma Section, at Sylvester Comprehensive Cancer Center, part of the University of Miami Miller School of Medicine today at 8:00 a.m. ET to discuss the results. To access the conference call, please register . "The data seen in this study with the combination of ZYNLONTA and glo tamab has shown a manageable safety pro le along with strong e cacy data from patients with relapsed or refractory DLBCL, with complete responses observed regardless of prior therapy, including CAR-T," said Mohamed Zaki, MD, PhD, Chief Medical O cer of ADC Therapeutics. "The combination of these two anti-cancer agents holds signi cant promise for advancing the treatment landscape and addressing unmet need in patients with these hard-to-treat lymphomas." The presentation highlights updated data as of April 14, 2025, in which r/r LBCL patients received dose levels of 120 µg/kg or 150 µg/kg of ZYNLONTA plus the bispeci c antibody glo tamab, with 41 patients evaluable for safety and 30 patients evaluable for e cacy. Key highlights of the LOTIS-7 data presentation are as follows: Best overall response data among the 30 e cacy evaluable patients shows overall response rate (ORR) of 93.3% (28/30 pts) as assessed by Lugano Criteria Complete response (CR) rate of 86.7% (26/30 pts) Of these, 25/26 patients achieving CR remain in CR as of the data cut-o Median time to CR in 120 µg/kg = 80 days Median time to CR in 150 µg/kg = 42 days 12 patients converted from stable disease (SD) or partial response (PR) to CR over time (1 and 11 pts respectively) Of the 6 patients previously treated with CAR-T and undergoing response assessment, 5 achieved a CR Among the 41 safety evaluable patients, the combination was generally well tolerated with a manageable safety pro le and no DLTs across dose levels Grade 3 or higher treatment emergent adverse events (TEAEs) observed in > 5% of patients included neutropenia (24.4%), anemia (9.8%), AST increased (7.3%), GGT increased (7.3%), and thrombocytopenia (7.3%) In the 150 µg/kg dose, cytokine release syndrome (CRS) (23.8%), all of which were Grade 1, and immune e ector cell- associated neurotoxicity syndrome (ICANS) (4.8%), with one case of Grade 2, were observed In the 120 µg/kg dose, CRS all grades (55%), all of which were Grade 1/2 except one case of Grade 3, and ICANS (10%), with one case of Grade 1 and one case of Grade 2, were observed TEAEs leading to discontinuation included 3 each for ZYNLONTA and glo tamab There were no Grade 5 TEAEs observed ® ®
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"We believe these new data are di erentiating and further reinforce the potential of ZYNLONTA plus the bispeci c glo tamab to improve outcomes for DLBCL patients who need it most," said Ameet Mallik, Chief Executive O cer of ADC Therapeutics. "This early safety and e cacy data support the ongoing expansion of this study to 100 patients at the 150 µg/kg dose of ZYNLONTA plus glo tamab. We look forward to discussing the results with Dr. Alderuccio during our conference call today in addition to the presentation of the data set across two key conferences." This data will be shared at EHA2025 during a poster presentation on June 14 at 6:30 p.m. CEST and also as an oral encore presentation at the 18th International Conference on Malignant Lymphoma (ICML) in Lugano, Switzerland on Friday, June 20 at 9:00 a.m. ET. The Company plans to share additional data before the end of 2025. Conference Call Information To access the conference call, please register . The participant toll-free dial-in number is 1-800-836-8184 for North America and Canada. It is recommended that you join 10 minutes before the event, though you may pre-register at any time. A live webcast of the call will be available under "Events and Presentations" in the Investors section of the ADC Therapeutics website at . The archived webcast will be available for 30 days following the call. About LOTIS-7 LOTIS-7 is a Phase 1b global multicenter, multi-arm study in patients with relapsed or refractory B-cell non-Hodgkin lymphoma (B- NHL) including Part 1 (dose escalation) and Part 2 (dose expansion). The three dosing arms include ZYNLONTA plus polatuzumab vedotin, ZYNLONTA plus glo tamab, and ZYNLONTA plus mosunetuzumab T-cell-engaging bispeci c monoclonal antibodies (BsAbs). Enrollment in LOTIS-7 includes Part 1 of the study with a 3+3 dose escalation in 3L/3L+ heavily pre-treated patients with ZYNLONTA doses starting at 90 µg/kg and then proceeding to 120 µg/kg and 150 µg/kg. Part 2 includes dose expansion in 2L/2L+ large B-cell lymphoma in the ZYNLONTA plus glo tamab arm at dose levels determined from Part 1 (120 µg/kg and 150 µg/kg of ZYNLONTA plus the approved dosing of glo tamab). Primary endpoints of the study include safety and tolerability. Secondary e cacy endpoints include ORR, DOR, CRR, PFS, RFS, and OS as well as pharmacokinetics and immunogenicity. For more information about the LOTIS-7 trial, visit (NCT04970901). About ZYNLONTA ZYNLONTA is a CD19-directed antibody drug conjugate (ADC). Once bound to a CD19-expressing cell, ZYNLONTA is internalized by the cell, where enzymes release a pyrrolobenzodiazepine (PBD) payload. The potent payload binds to DNA minor groove with little distortion, remaining less visible to DNA repair mechanisms. This ultimately results in cell cycle arrest and tumor cell death. The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have approved ZYNLONTA (loncastuximab tesirine-lpyl) for the treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy, including di use large B-cell lymphoma (DLBCL) not otherwise speci ed (NOS), DLBCL arising from low-grade lymphoma and also high-grade B-cell lymphoma. The trial included a broad spectrum of heavily pre-treated patients (median three prior lines of therapy) with di cult-to-treat disease, including patients who did not respond to rst-line therapy, patients refractory to all prior lines of therapy, patients with double/triple hit genetics and patients who had stem cell transplant and CAR-T therapy prior to their treatment with ZYNLONTA. This indication is approved by the FDA under accelerated approval and in the European Union under conditional approval based on overall response rate and continued approval for this indication may be contingent upon veri cation and description of clinical bene t in a con rmatory trial. Please see full prescribing information including important safety information about ZYNLONTA at . ZYNLONTA is also being evaluated as a therapeutic option in combination studies in other B-cell malignancies and earlier lines of therapy. About ADC Therapeutics ADC Therapeutics (NYSE: ADCT) is a commercial-stage biotechnology company helping to improve the lives of those a ected by cancer with its next-generation, targeted antibody drug conjugates (ADCs). The Company is advancing its proprietary ADC technology to transform the treatment paradigm for patients with hematologic malignancies and solid tumors. ADC Therapeutics' CD19-directed ADC ZYNLONTA (loncastuximab tesirine-lpyl) received accelerated approval by the FDA and conditional approval from the European Commission for the treatment of relapsed or refractory di use large B-cell lymphoma after two or more lines of systemic therapy. ZYNLONTA is also in development in combination with other agents and in earlier lines of therapy. In addition to ZYNLONTA, ADC Therapeutics has multiple ADCs in ongoing clinical and preclinical development. ® ®
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ADC Therapeutics is based in Lausanne (Biopôle), Switzerland and has operations in London and New Jersey. For more information, please visit https://adctherapeutics.com/ and follow the Company on . ZYNLONTA is a registered trademark of ADC Therapeutics SA. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including statements regarding the potential of ZYNLONTA in combination with the bispeci c antibody glo tamab, including the reproducibility and durability of any favorable results initially seen in patients dosed to date, and the Company's research, development and regulatory plans, including the timing and results of clinical trials and the timing and outcome of regulatory submissions. In some cases you can identify forward-looking statements by terminology such as "may", "will", "should", "would", "expect", "intend", "plan", "anticipate", "believe", "estimate", "predict", "potential", "seem", "seek", "future", "continue", or "appear" or the negative of these terms or similar expressions, although not all forward-looking statements contain these identifying words. Forward-looking statements are subject to certain risks and uncertainties that can cause actual results to di er materially from those described. Factors that may cause such di erences include, but are not limited to: whether future LOTIS-7 clinical trial results will be consistent with or di erent from the LOTIS-7 data presented at EHA and ICML and future compendia and regulatory strategy and opportunity; the expected cash runway into mid-2026 the Company's ability to grow ZYNLONTA revenue in the United States; the ability of our partners to commercialize ZYNLONTA in foreign markets, the timing and amount of future revenue and payments to us from such partnerships and their ability to obtain regulatory approval for ZYNLONTA in foreign jurisdictions; the timing and results of the Company's or its partners' research and development projects or clinical trials including LOTIS 5 and 7, as well as early research in certain solid tumors with di erent targets, linkers and payloads; the timing and results of investigator-initiated trials including those studying FL and MZL and the potential regulatory and/or compendia strategy and the future opportunity; the timing and outcome of regulatory submissions for the Company's products or product candidates; actions by the FDA or foreign regulatory authorities; projected revenue and expenses; the Company's indebtedness, including Healthcare Royalty Management and Blue Owl and Oaktree facilities, and the restrictions imposed on the Company's activities by such indebtedness, the ability to comply with the terms of the various agreements and repay such indebtedness and the signi cant cash required to service such indebtedness; and the Company's ability to obtain nancial and other resources for its research, development, clinical, and commercial activities. Additional information concerning these and other factors that may cause actual results to di er materially from those anticipated in the forward-looking statements is contained in the "Risk Factors" section of the Company's Annual Report on Form 10-K and in the Company's other periodic and current reports and lings with the U.S. Securities and Exchange Commission. These statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance, achievements or prospects to be materially di erent from any future results, performance, achievements or prospects expressed in or implied by such forward-looking statements. The Company cautions investors not to place undue reliance on the forward-looking statements contained in this document. CONTACTS: Investor Relations Marcy Graham ADC Therapeutics +1 650-667-6450 Media Relations Nicole Riley ADC Therapeutics +1 862-926-9040 View original content to download multimedia:https://www.prnewswire.com/news-releases/adc-therapeutics-announces- updated-data-from-lotis-7-clinical-trial-presented-at-the-european-hematology-association-2025-congress-302479844.html SOURCE ADC Therapeutics SA ® ® ® ® ®