{"url_path":"/sec/adct/8-k/2026-06-03/item-8-01","section_key":"item-8-01","section_title":"Item 8.01 Other Events.**","topic":"sec","document":{"doc_type":"8-K","doc_date":"2026-06-03","source_url":"https://www.sec.gov/Archives/edgar/data/1771910/0000950103-26-008465-index.html","accession_number":"0000950103-26-008465","cik":"0001771910","ticker":"ADCT","issuer_name":"ADC Therapeutics SA","edgar_url":"https://www.sec.gov/Archives/edgar/data/1771910/0000950103-26-008465-index.html","primary_entity_key":"0001771910","primary_entity_name":"ADC Therapeutics SA"},"word_count":1089,"has_tables":true,"body_markdown":"**Item 8.01. Other Events.**\n\n \n\nOn June 3, 2026, the Company announced topline data from its Phase\n3 LOTIS-5 confirmatory trial evaluating ZYNLONTA® (*loncastuximab tesirine-lpyl*) in combination with rituximab in patients with\nrelapsed or refractory diffuse large B-cell lymphoma (“r/r DLBCL”). The LOTIS-5 trial is a randomized, open-label, two-arm,\nmulticenter study evaluating ZYNLONTA plus rituximab versus the standard immunochemotherapy rituximab gemcitabine-oxaliplatin (R-GemOx),\nfor the treatment of r/r DLBCL after one or more lines of systemic therapy.\n\n \n\nThe study met the primary endpoint of progression-free survival\n(“PFS”) (per independent review committee) with statistical significance (HR = 0.73; p-value = 0.008 two sided), with a\nmedian PFS of 6.1 months for ZYNLONTA plus rituximab vs 4.7 months for R-GemOx. Overall survival showed no detrimental effect with\nZYNLONTA plus rituximab compared to the control arm (HR = 0.96, impacted by the earlier use and a higher rate of new anti-lymphoma\ntreatment switching in the control arm). Overall response rate (“ORR”) was 58.1% vs. 45.2%, complete response\n(“CR”) rate was 39.5% vs. 26.7%, median duration of response (“DOR”) was 9.2 months vs. 7.7 months, and\nmedian duration of CRs (“DoCR”) was 16.8 months vs. 12.3 months for ZYNLONTA plus rituximab compared to R-GemOx,\nrespectively. Of patients achieving CR, 48.5% vs. 16.7% remained in CR at 24 months in favor of ZYNLONTA plus rituximab. Of note,\nresults in North America were consistent with the overall study results.\n\n \n\nOverall, treatment emergent adverse event (“TEAE”) rates\nwere similar between arms (98.5% vs. 97.5%). Higher rates of serious adverse events (“SAEs”) were seen in the test arm (49.0%\nvs. 34.5%). Grade ≥3 TEAEs observed in > 5% of patients were hematologic (40.7% vs. 59.4%), followed by infection/infestations (24.5%\nvs. 15.7%), then hepatotoxicity (17.2% vs. 8.1%) and oedema/effusion (7.4% vs. 0.5%) when comparing ZYNLONTA plus rituximab to R-GemOx.\nA higher rate of Grade 5 TEAEs was observed in the ZYNLONTA plus rituximab arm (27 pts/13.2%) vs. R-GemOx (9 pts/4.6%). Of note, the majority\nof Grade 5 TEAEs in the test arm occurred in patients aged 75 years or older. Higher rates of TEAEs leading to any drug withdrawal occurred\nin the ZYNLONTA plus rituximab arm (25.5% vs. 9.1%). In this study, the TEAE reporting window was defined as 105 days after the last dose\nof study treatment or the start of new anticancer therapy, whichever is earlier. The rates of TEAEs in this study were impacted by the\nlonger overall TEAE observation time in the test vs. control arm. This difference is primarily driven by a higher rate of and earlier\nswitching to subsequent therapies in the control arm.\n\n \n\nBased on these topline results from LOTIS-5, the Company plans to conduct\na pre-Supplemental Biologics License Application (“sBLA”) meeting with the U.S. Food and Drug Administration (“FDA”)\nin August and is preparing for a planned sBLA submission in the fourth quarter of 2026. In addition, the Company will continue to evaluate\na broad range of value maximizing alternatives, including but not limited to near-term cost reduction initiatives.\n\n \n\n \n\n \n\n*This report contains forward-looking statements within the meaning\nof the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. In some cases you can identify forward-looking\nstatements by terminology such as \"may\", \"will\", \"should\", \"would\", \"expect\", \"intend\",\n\"plan\", \"anticipate\", \"believe\", \"estimate\", \"predict\", \"potential\", \"seem\",\n\"seek\", \"future\", \"continue\", or \"appear\" or the negative of these terms or similar expressions,\nalthough not all forward-looking statements contain these identifying words. Forward-looking statements are subject to certain risks and\nuncertainties that can cause actual results to differ materially from those described. Factors that may cause such differences include,\nbut are not limited to: the adequacy of the LOTIS-5 clinical trial data to support full regulatory approval and our ability to maintain\naccelerated approval in the United States and foreign jurisdictions for our product; the timing, content and outcome of meetings with\nand feedback or other communications provided by regulatory authorities including U.S. FDA; the timing, submission and acceptance of an\nsBLA submission related to LOTIS-5 and potential approval; the actual and perceived benefit-risk profile for ZYNLONTA as studied in the\nLOTIS-5 trial; the assessment of the data from LOTIS-5 study, including additional analyses of outcomes observed for safety, efficacy\nand within key geographic regions and across certain patient sub-populations; the path for full regulatory approval for ZYNLONTA in the\nUnited States and foreign jurisdictions; our ability to identify and execute value-maximizing options and the cost and impact of such\noptions; our expected cash runway into at least 2028; our ability to comply with the terms of our indebtedness; changes in our regulatory\nand commercial strategy; the Company's ability to sustain or grow ZYNLONTA® revenue in the United States and potential peak revenue;\nthe ability of our partners to commercialize ZYNLONTA® in foreign markets, the timing and amount of future revenue and payments to\nus from such partnerships and their ability to obtain regulatory approval for ZYNLONTA® in foreign jurisdictions; the timing, results\nand publication of the Company's clinical trials including LOTIS-7; the timing, publication and results of investigator-initiated trials\nincluding those studying FL and MZL and the potential regulatory and/or compendia strategy and the future opportunity; the timing and\noutcome of regulatory submissions for the Company's products or product candidates; actions by the FDA or foreign regulatory authorities;\nprojected revenue and expenses; the Company's indebtedness, including HealthCare Royalty Management and Blue Owl and Oaktree facilities,\nand the restrictions imposed on the Company's activities by such indebtedness, the ability to comply with the terms of the various agreements\nand repay such indebtedness and the significant cash required to service such indebtedness; and the Company's ability to obtain financial\nand other resources for its research, development, clinical, and commercial activities; and the uncertainties of international trade policies,\nincluding tariffs, sanctions, trade barriers and most favored nation drug pricing and the potential impact they may have on our business,\nfinancial condition, and results of operations. Additional information concerning these and other factors that may cause actual results\nto differ materially from those anticipated in the forward-looking statements is contained in the \"Risk Factors\" section of\nthe Company's Annual Report on Form 10-K and in the Company's other periodic and current reports and filings with the U.S. Securities\nand Exchange Commission. These statements involve known and unknown risks, uncertainties and other factors that may cause actual results,\nperformance, achievements or prospects to be materially different from any future results, performance, achievements or prospects expressed\nin or implied by such forward-looking statements. The Company cautions investors not to place undue reliance on the forward-looking statements\ncontained in this document.*"}