ADC Therapeutics SA (NYSE: ADCT) today announced that updated results from LOTIS-2, the pivotal Phase 2 clinical trial of ZYNLONTA® (loncastuximab-tesirin-Lpyl) in patients with relapsed/refractory diffuse large B-cell disease Lymphoma (DLBCL), have been approved for presentation at the European Hematology Association Hybrid Congress 2023 (EHA2023) to be held June 8-11, 2023 in Frankfurt am Main.
“We are encouraged by the recent developments of our pivotal LOTIS-2 study, which further confirms the long-term disease control of ZYNLONTA in heavily pretreated patients with DLBCL,” said Mohamed Zaki, MD, PhD, Chief Medical Officer of ADC Therapeutics. “ZYNLONTA possesses significant antitumor activity as a single agent, producing durable responses with an acceptable safety profile. We look forward to sharing our new data with the hematology community at EHA2023.”
Details of ADC Therapeutics’ poster presentation are as follows:
Long-term responses with loncastuximab tesirine: updated results from LOTIS-2, the pivotal phase 2 study in patients with relapsed/refractory diffuse large B-cell lymphoma
Session: Aggressive Non-Hodgkin’s Lymphoma – Clinical
Session Date and Time: Friday, June 9, 2023, 6-7 PM CEST // 12-1 PM EDT
Location: poster area
Location Time: The poster area opens at 9 a.m. CEST
Presenting Author: Paolo F. Caimi, MD, Cleveland Clinic Taussig Cancer Center, Cleveland, OH, USA
Abstract code: P1132
About ZYNLONTA® (Loncastuximab-Tesirin-Lpyl)
ZYNLONTA® is a CD19-targeted antibody-drug conjugate (AWC). Once bound to a CD19-expressing cell, ZYNLONTA is internalized by the cell where enzymes release a pyrrolobenzodiazepine (PBD) payload. The highly potent payload binds to the minor groove of DNA with little distortion, making it less visible to DNA repair mechanisms. This ultimately stops the cell cycle and the tumor cells die.
The U.S. Food and Drug Administration (FDA) has approved ZYNLONTA (loncastuximab-Tesirin-Lpyl) for the treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma following two or more lines of systemic therapy, including DLBCL Not Otherwise Specified, DLBCL, arising from low-grade lymphoma and also high-grade B-cell lymphoma. The study included a broad spectrum of heavily pretreated patients (median of three prior lines of therapy) with difficult-to-treat disease, including patients who were refractory to first-line therapy, patients who were refractory to all prior lines of therapy, patients with double/triple hit Genetics and patients who received stem cell transplantation and CAR-T therapy prior to their treatment with ZYNLONTA. This indication was approved by the FDA under accelerated approval based on overall response rate. Further approval for this indication may be subject to verification and description of the clinical benefit in a confirmatory study. For full prescribing information, including important safety information, for ZYNLONTA, visit www.ZYNLONTA.com.
ZYNLONTA is also being evaluated in combination studies as a treatment option for other B-cell malignancies and in earlier lines of therapy.
About ADC Therapeutics
ADC Therapeutics (NYSE: ADCT) is a commercial global leader and pioneer in antibody-drug conjugates (ADCs). The Company is advancing the development of its proprietary AWK technology to transform the treatment paradigm for patients with hematologic malignancies and solid tumors.
ADC Therapeutics’ CD19-targeting ZYNLONTA® (loncastuximab-tesirin-Lpyl) AWK received US Food and Drug Administration (FDA) fast track approval and European Medicines Agency (EMA) conditional approval for the treatment of relapsed or refractory diffuse large B-cell disease lymphoma after two or more lines of systemic therapy. ZYNLONTA is also being developed in combination with other active ingredients and in earlier lines of therapy. In addition to ZYNLONTA, ADC Therapeutics has several ADCs in ongoing clinical and pre-clinical development.
ADC Therapeutics is based in Lausanne (Biopôle), Switzerland, with offices in London, the San Francisco Bay Area and New Jersey. For more information, please visit https://adctherapeutics.com/ and follow the company on Twitter and LinkedIn.
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. Forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially from those described. Factors that may cause such discrepancies include, but are not limited to: the utility of updated clinical data from the LOTIS-2 study of ZYNLONTA® to be presented at EHA 2023, if any; the success of the Company’s updated corporate strategy, including operational efficiencies, capital deployment and portfolio prioritization; the Company’s ability to achieve its 2023 projected ZYNLONTA® net sales and total cost of ownership declines for 2023 and 2024, the expected liquidity through mid-2025, the effectiveness of the new commercial go-to-market strategy and the Company’s ability to continue commercializing ZYNLONTA® in the United States and future income therefrom; Swedish Orphan Biovitrum AB’s (Sobi®) ability to successfully commercialize ZYNLONTA® in the European Economic Area and market acceptance, reasonable reimbursement and future revenues therefrom; the ability of our strategic partners, including Mitsubishi Tanabe Pharma Corporation and Overland Pharmaceuticals, to obtain approval of ZYNLONTA® in foreign jurisdictions and the timing and amount of future revenues and payments to us from such partnerships; the Company’s ability to market its products in compliance with applicable laws and regulations; the Company’s expectations regarding the impact of the Infrastructure Investment and Jobs Act; the timing and results of the Company’s or its partners’ research projects or clinical trials, including LOTIS 5, 7 and 9, ADCT 901, 601 and 602, the timing and outcome of any regulatory submissions and actions by the FDA or other regulatory agencies related to the products or the Company’s product candidates; projected income and expenses; the Company’s indebtedness, including the Healthcare Royalty Management and Blue Owl and Oaktree Facilities, and the limitations imposed by such indebtedness on the Company’s activities, the ability to repay such indebtedness and the substantial cash required to service them debt are required; the Company’s ability to obtain financial and other resources for its research, development, clinical and commercial activities; and other statements on matters that are not historical facts and involve predictions. These statements involve known and unknown risks, uncertainties and other factors that could cause actual results, performance, achievements or prospects to differ materially from future results, performance, achievements or prospects expressed in such forward-looking statements or be implied. In some cases, you can identify forward-looking statements by using words such as “may”, “will”, “should”, “would”, “expect”, “intend”, “plan”, “anticipate”, “believe”, “estimate” , “anticipate”, “potential”, “appear”, “intend”, “future”, “continue” or “appear” or the negative of such terms or similar expressions, although not all forward-looking statements contain these identifying words. Additional information about these and other factors that could cause actual results to differ materially from those anticipated in the forward-looking statements can be found in the “Risk Factors” section of the Company’s Annual Report on Form 20-F and in the other periodic reports and Company’s filings with the Securities and Exchange Commission. The company cautions investors not to place undue reliance on the forward-looking statements contained in this document. The Company undertakes no obligation to revise or update these forward-looking statements to reflect events or circumstances after the date of this press release, except as required by law.
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