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ADC Therapeutics Announces Investigator-Initiated Study Abstracts Accepted for Presentation at the 66th ASH Annual Meeting

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ADC Therapeutics (NYSE: ADCT) announced two investigator-initiated study abstracts on ZYNLONTA accepted for presentation at the 66th ASH Annual Meeting. The Phase 2 study combining ZYNLONTA with rituximab in relapsed/refractory follicular lymphoma showed a 97.1% overall response rate among 35 patients, with an 80% best complete metabolic response rate. In a separate study for relapsed/refractory marginal zone lymphoma, ZYNLONTA as a single agent achieved an 85% overall response rate with 75% complete response rate in 20 evaluable patients. Both studies demonstrated safety profiles consistent with known ZYNLONTA data.

ADC Therapeutics (NYSE: ADCT) ha annunciato due abstract di studi avviati da investigatori su ZYNLONTA accettati per la presentazione al 66° Congresso Annuale ASH. Lo studio di fase 2 che combina ZYNLONTA con rituximab nel linfoma follicolare in fase di ricaduta/resistenza ha mostrato un tasso di risposta globale del 97,1% tra 35 pazienti, con un tasso di risposta metabolica completa migliore dell'80%. In un altro studio per linfoma marginale in fase di ricaduta/resistenza, ZYNLONTA come singolo agente ha raggiunto un tasso di risposta globale dell'85% con un tasso di risposta completa del 75% in 20 pazienti valutabili. Entrambi gli studi hanno dimostrato profili di sicurezza coerenti con i dati noti su ZYNLONTA.

ADC Therapeutics (NYSE: ADCT) anunció dos resúmenes de estudios iniciados por investigadores sobre ZYNLONTA que fueron aceptados para su presentación en la 66ª Reunión Anual de ASH. El estudio de fase 2 que combina ZYNLONTA con rituximab en linfoma folicular en recaída/refractario mostró una tasa de respuesta global del 97.1% entre 35 pacientes, con una tasa de respuesta metabólica completa óptima del 80%. En un estudio separado para linfoma de zona marginal en recaída/refractario, ZYNLONTA como agente único alcanzó una tasa de respuesta global del 85% con una tasa de respuesta completa del 75% en 20 pacientes evaluables. Ambos estudios demostraron perfiles de seguridad consistentes con los datos conocidos de ZYNLONTA.

ADC Therapeutics (NYSE: ADCT)는 ZYNLONTA에 대한 두 개의 연구자 주도 연구 초록이 66회 ASH 연례 회의에서 발표될 것으로 수락되었다고 발표했습니다. 재발/내성 여포 림프종에서 ZYNLONTA와 리툭시맙을 결합한 2상 연구는 35명의 환자 중 97.1%의 전반적인 반응률과 80%의 최선의 완전 대사 반응률을 보여주었습니다. 재발/내성 가장자 림프종에 대한 별도의 연구에서, 단일 제제로서의 ZYNLONTA는 20명의 평가 가능 환자 중 85%의 전반적인 반응률과 75%의 완전 반응률을 달성했습니다. 두 연구 모두 ZYNLONTA에 대한 알려진 데이터와 일관된 안전성 프로필을 보여주었습니다.

ADC Therapeutics (NYSE: ADCT) a annoncé que deux résumés d'études initiées par des chercheurs sur ZYNLONTA ont été acceptés pour présentation lors de la 66e Réunion Annuelle de l'ASH. L'étude de phase 2 combinant ZYNLONTA avec le rituximab dans le lymphome folliculaire en rechute/résistant a montré un taux de réponse global de 97,1 % parmi 35 patients, avec un taux de réponse métabolique complet optimal de 80 %. Dans une étude séparée pour le lymphome des zones marginales en rechute/résistant, ZYNLONTA en tant qu'agent unique a atteint un taux de réponse global de 85 % avec un taux de réponse complète de 75 % chez 20 patients évaluables. Les deux études ont démontré des profils de sécurité cohérents avec les données connues sur ZYNLONTA.

ADC Therapeutics (NYSE: ADCT) gab bekannt, dass zwei von Forschern initiierte Studienabstracts über ZYNLONTA zur Präsentation auf dem 66. ASH-Jahrestreffen akzeptiert wurden. Die Phase-2-Studie, die ZYNLONTA mit Rituximab bei rezidivierenden/refraktären follikulären Lymphomen kombinierte, zeigte eine Gesamtansprechrate von 97,1% bei 35 Patienten und eine optimale vollständige metabolische Ansprechrate von 80%. In einer separaten Studie zu rezidivierenden/refraktären marginalen Zonenlymphomen erreichte ZYNLONTA als Einzelmittel eine Gesamtansprechrate von 85% mit einer vollständigen Ansprechrate von 75% bei 20 auswertbaren Patienten. Beide Studien zeigten Sicherheitsprofile, die mit den bekannten Daten zu ZYNLONTA übereinstimmten.

Positive
  • 97.1% overall response rate in follicular lymphoma combination study
  • 80% best complete metabolic response rate in follicular lymphoma study
  • 85% overall response rate in marginal zone lymphoma study
  • 75% complete response rate in marginal zone lymphoma study
Negative
  • None.

Insights

The Phase 2 study results for ZYNLONTA combination therapy show remarkable efficacy with an 97.1% overall response rate in follicular lymphoma patients. This is significantly higher than typical response rates for current treatments. The 80% complete metabolic response rate is particularly impressive, suggesting strong durability of treatment.

The single-agent study in marginal zone lymphoma also demonstrates exceptional results with an 85% overall response rate and 75% complete response rate. These numbers substantially exceed historical benchmarks for this indication, potentially positioning ZYNLONTA as a leading treatment option.

The consistent safety profile across both studies strengthens ZYNLONTA's market position. These results could support label expansion and increased adoption, particularly in earlier treatment lines where response durability is crucial.

Oral presentation of investigator-initiated Phase 2 study evaluating ZYNLONTA® (loncastuximab tesirine-lpyl) in combination with rituximab in patients with r/r follicular lymphoma

Poster presentation of first interim futility analysis of ongoing investigator-initiated Phase 2 clinical trial studying ZYNLONTA as treatment for r/r marginal zone lymphoma

LAUSANNE, Switzerland, Nov. 5, 2024 /PRNewswire/ -- ADC Therapeutics SA (NYSE: ADCT), a commercial-stage global leader and pioneer in the field of antibody drug conjugates (ADCs), today announced independent, investigator-initiated study abstracts on ZYNLONTA® (loncastuximab tesirine-lpyl) have been accepted for presentation at the 66th American Society of Hematology (ASH) Annual Meeting, which will be held in San Diego, California from December 7-10, 2024.

"Data from the abstract on the Phase 2 study of ZYNLONTA combined with rituximab in patients with high-risk relapsed or refractory follicular lymphoma demonstrated a robust response among the 35 evaluable patients, with an overall response rate at week 12 of 97.1%," said Mohamed Zaki, MD, PhD, Chief Medical Officer of ADC Therapeutics. "All complete metabolic responses were maintained, with 4 of the 10 partial metabolic responses improving at week 21 for a best complete metabolic response rate of 80%."  

"For relapsed or refractory marginal zone lymphoma, the abstract provides an update on ZYNLONTA as a single-agent treatment. As of the abstract submission date, the overall response rate was 85% with a complete response rate of 75% among the 20 evaluable patients," continued Dr. Zaki. "In both studies, safety was consistent with the known ZYNLONTA profile. We look forward to further updates at ASH."

Details of the investigator-initiated study oral presentation:

Title: Loncastuximab Tesirine with Rituximab Induces Robust and Durable Complete Metabolic Responses in High-Risk Relapsed/Refractory Follicular Lymphoma
Abstract: 337
Session Title: 623. Mantle Cell, Follicular, Waldenstrom's and Other Indolent B Cell Lymphomas: Clinical and Epidemiological: Novel Treatment Strategies and New Data on Old Standards for Follicular Lymphoma
Session Date and Time: Saturday, December 7, 2024; 4:00-5:30 p.m. PT
Presentation Time: 4:00 p.m. PT
Presenter: Juan Pablo Alderuccio, MD
Location: Marriott Marquis San Diego Marina, Marriott Grand Ballroom 11-13

Details of the investigator-initiated study poster presentation:

Title: Limited Duration Loncastuximab Tesirine Induces a High Rate of Complete Responses in Patients with Relapsed/Refractory Marginal Zone Lymphoma - Report of First Planned Interim Futility Analysis of a Multicenter Phase II Study
Abstract: 3032
Session Title: 623. Mantle Cell, Follicular, Waldenstrom's and Other Indolent B Cell Lymphomas: Clinical and Epidemiological: Poster II
Hall View Times: Sunday, December 8, 2024; 9:00 a.m. - 8:00 p.m. PT
Presentation Date and Time: Sunday, December 8, 2024; 6:00-8:00 p.m. PT
Location: San Diego Convention Center, Halls G-H

The abstracts are available through the ASH online meeting program.

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 and New Jersey. For more information, please visit the Company website at adctherapeutics.com and follow us 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: whether the interim data presented in the abstract from the University of Miami's investigator-initiated trials studying ZYNLONTA® in FL and MZL are predictive of future outcomes and the timing and future results for the same ongoing trials, the potential regulatory and/or compendia strategy and the future opportunity for ZYNLONTA® in FL and MZL; 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, ADCT 601 and 602 as well as early research in certain solid tumors with different targets, linkers and payloads; 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 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 10-K and in the Company's other periodic and current reports and filings 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 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.

CONTACTS:

Investors
Marcy Graham
ADC Therapeutics
Marcy.Graham@adctherapeutics.com
+1 650-667-6450

Media
Nicole Riley
ADC Therapeutics
Nicole.Riley@adctherapeutics.com
+1 862-926-9040

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SOURCE ADC Therapeutics SA

FAQ

What were the response rates for ZYNLONTA with rituximab in the Phase 2 follicular lymphoma study?

The study showed a 97.1% overall response rate at week 12 among 35 evaluable patients, with a best complete metabolic response rate of 80%.

What were the results of ZYNLONTA in the marginal zone lymphoma study?

In the marginal zone lymphoma study, ZYNLONTA achieved an 85% overall response rate and a 75% complete response rate among 20 evaluable patients.

When and where will ADC Therapeutics (ADCT) present the ZYNLONTA study results?

The results will be presented at the 66th ASH Annual Meeting in San Diego, California, from December 7-10, 2024.

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