Presentations to highlight clinical utility of ZYNLONTA® (loncastuximab tesirine-lpyl) as a single agent and in combination
Oral presentation to include initial results of investigator-initiated Phase 2 study evaluating ZYNLONTA in combination with rituximab in patients with r/r follicular lymphoma
LAUSANNE, Switzerland, Nov. 02, 2023 (GLOBE NEWSWIRE) -- ADC Therapeutics SA (NYSE: ADCT) today announced abstracts on ZYNLONTA® (loncastuximab tesirine-lpyl) have been accepted for presentation at the 65th American Society of Hematology (ASH) Annual Meeting, which will be held in San Diego, California from December 9-12, 2023.
"We look forward to sharing insights from the growing body of research supporting the clinical utility of ZYNLONTA as a single agent and in combination with other treatments at the 65th ASH Annual Meeting,” said Mohamed Zaki, MD, PhD, Chief Medical Officer of ADC Therapeutics. “In addition, we are encouraged by the initial results of an investigator-initiated Phase 2 study evaluating ZYNLONTA in combination with rituximab in patients with relapsed or refractory follicular lymphoma. The combination was well tolerated with a 95% overall response rate at week 12 and at week 21, an 86% metabolic complete response rate. We look forward to additional details to be shared during the oral presentation.”
Details of the oral presentation of the investigator-initiated study:
Title: Limited Duration Loncastuximab Tesirine with Rituximab Induces High Complete Metabolic Response Rate in High-Risk Relapsed/Refractory Follicular Lymphoma – A Phase 2 Study
Abstract: 984
Session: 623. Mantle Cell, Follicular, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological: Targeted Therapy
Date and Time: Monday, December 11, 2023; 5:45 PM PT
Location: Manchester Grand Hyatt San Diego, Grand Hall C
Presenter: Juan Pablo Alderuccio, MD
Details of selected poster presentations:
Title: Early and Sustained Circulating Tumor DNA Response Dynamics after Loncastuximab Tesirine for Relapsed/Refractory Diffuse Large B-Cell Lymphoma
Abstract: 3133
Session: 627. Aggressive Lymphomas: Clinical and Epidemiological; Poster II Presentations
Date and Time: Sunday, December 10, 2023; 6:00 PM - 8:00 PM PT
Title: A Global Study of Novel Agents in Paediatric and Adolescent Relapsed and Refractory B-Cell Non-Hodgkin Lymphoma (Glo-BNHL)
Abstract: 3097
Session: 626. Aggressive Lymphomas: Prospective Therapeutic Trials; Poster II Presentations
Date and Time: Sunday, December 10, 2023; 6:00 PM - 8:00 PM PT
Title: Loncastuximab Tesirine Demonstrated Substantial Single-agent Efficacy and Manageable Safety Profile in Heavily Pretreated Chinese Patients with Relapsed or Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL)
Abstract: 4469
Session: 626. Aggressive Lymphomas: Prospective Therapeutic Trials; Poster III Presentations
Date and Time: Monday, December 11, 2023; 6:00 PM - 8:00 PM PT
Posters will be available in the poster exhibit halls (Halls G-H) at the San Diego Convention Center on December 10, 2023, from 9:00 AM - 8:00 PM PT (Poster II Presentations) and on December 11, 2023, from 9:00 AM - 8:00 PM PT (Poster III Presentations). Presenters planning to attend in person are expected to present during the final two hours of the noted viewing time. Presentations will also be available on a virtual platform.
The abstracts are available through the ASH online meeting program.
About ZYNLONTA® (loncastuximab tesirine-lpyl)
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 diffuse large B-cell lymphoma (DLBCL) not otherwise specified (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 difficult-to-treat disease, including patients who did not respond to first-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 verification and description of clinical benefit in a confirmatory trial. Please see full prescribing information including important safety information about ZYNLONTA at www.ZYNLONTA.com.
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 global leader and pioneer in the field of 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 diffuse 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.
ADC Therapeutics is based in Lausanne (Biopôle), Switzerland and has operations in London, the San Francisco Bay Area and New Jersey. For more information, please visit https://adctherapeutics.com/ and follow the Company on 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. 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 differ materially from those described. Factors that may cause such differences include, but are not limited to: uncertainties related to the impact of data presented at the 65th ASH Annual Meeting and future results, the success of the Company’s updated corporate strategy including operating efficiencies, capital deployment and portfolio prioritization; the Company’s ability to achieve the decrease in total operating expenses for 2023 and 2024, the expected cash runway into the middle of 2025, the effectiveness of the new commercial go-to-market strategy, competition from new technologies, the Company’s ability to continue to commercialize ZYNLONTA® in the United States and future revenue from the same; Swedish Orphan Biovitrum AB (Sobi®) ability to successfully commercialize ZYNLONTA® in the European Economic Area and market acceptance, adequate reimbursement coverage, and future revenue from the same; approval by the NMPA of the BLA for ZYNLONTA in China submitted by Overland ADCT BioPharma and future revenue from the same, our strategic partners’, including Mitsubishi Tanabe Pharma Corporation, ability to obtain regulatory approval for ZYNLONTA® in foreign jurisdictions, and the timing and amount of future revenue 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 and 7, ADCT 901, 601 and 602, the impact, if any, from discontinuation of the LOTIS-9 study, actions by the FDA or foreign regulatory authorities with respect to the Company’s products or product candidates, the timing and outcome of regulatory submissions for the Company’s products or product candidates; the ability to complete clinical trials on expected timelines, if at all; 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 repay such indebtedness and the significant cash required to service such indebtedness; and the Company’s ability to obtain financial and other resources for its research, development, clinical, and commercial activities. Additional information concerning these and other factors that may cause actual results to differ materially from those anticipated in the forward-looking statements is contained in the “Risk Factors” section of the Company's Annual Report on Form 20-F and in the Company's other periodic reports and filings with the 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 different 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. 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.
CONTACTS:
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Eugenia Litz
ADC Therapeutics
Eugenia.Litz@adctherapeutics.com
+44 7879 627205
+1 908-723-2350
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Nicole Riley
ADC Therapeutics
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+1 862-926-9040
