ADC Therapeutics announces the validation of its marketing authorization request by the European Medicines Agency for ZYNLONTA®

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Data-supported application from the LOTIS-2 pivotal trial in adult patients with relapsed or refractory diffuse large B-cell lymphoma

Milestone Achieved in Commitment to Make ZYNLONTA Widely Available to Patients in Need

LAUSANNE, Switzerland – (BUSINESS WIRE) – ADC Therapeutics (NYSE: ADCT), a commercial-stage biotechnology company that is improving the lives of people living with cancer with its next-generation antibody-targeted drug (ADC) conjugates for patients with malignant and solid tumors, today announced that its Marketing Authorization Application (MAA) for ZYNLONTA®, an ADC targeted to CD19 for the treatment of diffuse large B-cell lymphoma (DLBCL) in relapse or refractory, has been validated by the European Medicines Agency (EMA)). The validation of the dossier makes it possible to launch the evaluation process by the EMA’s Committee for Medicinal Products for Human Use (CHMP).

“We continue to gain momentum with the launch of ZYNLONTA in the United States and we are excited to move forward in Europe with the submission and validation of our MAA,” said Chris Martin, PhD, Managing Director of ADC Therapeutics . “This is an important step in our commitment to make ZYNLONTA available to as many patients as possible. “

In April 2021, the United States Food and Drug Administration (FDA) granted fast-track approval to ZYNLONTA as the first and only CD19-targeted ADC as a monotherapy treatment for adult patients with relapsed or relapsed DLBCL. refractory after two or more lines of systemic therapy. In September 2021, the European Commission granted the orphan drug designation to ZYNLONTA for the treatment of DLBCL.

AMA is supported by data from LOTIS-2, a large multinational (n = 145) phase 2 single-arm clinical trial of ZYNLONTA for the treatment of adult patients with relapsed or refractory LDGCB following two or more previous lines of systemic treatment. The trial included a wide range of heavily pretreated patients (median of three previous treatment lines) with very difficult to treat disease, including patients with high-grade B-cell lymphoma. The trial included patients who did not respond to first-line treatment, patients refractory to all previous treatment lines, patients with double / triple hit genetics, and patients who underwent stem cell transplants and CAR-T treatment before their treatment with ZYNLONTA.

LOTIS-2 results demonstrated an overall response rate (ORR) of 48.3% (70/145 patients), which included a complete response rate (CR) of 24.1% (35/145 patients) and a partial response rate (PR) of 24.1% (35/145 patients). Patients had a median time to response of 1.3 months. At the last data cutoff for the patients included in the trial, the median duration of response (mDoR) was 13.4 months. In a pooled safety population, the most common adverse reactions (≥ 20%) were thrombocytopenia, increased gamma-glutamyltransferase, neutropenia, anemia, hyperglycemia, elevated transaminases, fatigue , hypoalbuminemia, rash, edema, nausea and musculoskeletal pain. In LOTIS-2, the most common grade ≥3 grade ≥3 adverse events (≥10%) were neutropenia (26.2%), thrombocytopenia (17.9%), increased gamma- glutamyltransferase (17.2%) and anemia (10.3%).

About ZYNLONTA® (loncastuximab tesirine-lpyl)

ZYNLONTA® is an antibody-drug conjugate (ADC) directed against CD19. Once bound to a CD19 expressing cell, ZYNLONTA is internalized by the cell, where enzymes release a pyrrolobenzodiazepine (PBD) payload. The powerful payload binds to the 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 United States 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 after two or more lines treatment, including B-cell lymphoma (DLBCL) not otherwise specified (NOS), DLBCL resulting from low-grade lymphoma and also high-grade B-cell lymphoma. The trial included a wide range of heavily pretreated patients (median of three previous treatment lines) with difficult-to-treat disease, including patients who did not respond to first-line treatment, patients refractory to all previous treatment lines, patients with double / triple hit genetics and patients who underwent stem cell transplantation and CAR-T therapy prior to their treatment with ZYNLONTA. This indication is approved by the FDA under accelerated approval based on overall response rate and continued approval for this indication may depend on verification and description of clinical benefit in a confirmatory trial.

ZYNLONTA is also being evaluated as a therapeutic option in combined studies in other B-cell malignancies and in previous lines of therapy.

About ADC Therapeutics

ADC Therapeutics (NYSE: ADCT) is a commercial-stage biotechnology company that is improving the lives of people living with cancer with its next-generation Targeted Antibody-Drug Conjugates (ADCs). The Company is advancing its proprietary PBD-based ADC technology to transform the treatment paradigm for patients with hematologic malignancies and solid tumors.

ADC ZYNLONTA® (loncastuximab tesirin-lpyl) led by CD19 from ADC Therapeutics is FDA approved for the treatment of relapsed or refractory diffuse large b cell lymphoma after two or more lines of systemic therapy. ZYNLONTA is also under development in combination with other agents. Cami (camidanlumab tesirine) is being evaluated in an advanced clinical trial for relapsed or refractory Hodgkin lymphoma and in a phase 1b clinical trial for various advanced solid tumors. In addition to ZYNLONTA and Cami, ADC Therapeutics has several ADCs in clinical and preclinical development.

ADC Therapeutics is based in Lausanne (Biopôle), Switzerland and operates 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.



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