ADC Therapeutics Announces Initial Data from Investigator-Initiated Phase 2 Clinical Trial of ZYNLONTA in Patients with Relapsed/Refractory Marginal Zone Lymphoma - Seite 2

MZL is a rare, indolent non-Hodgkin lymphoma (NHL) and the third most common NHL subtype. There are few FDA-approved therapies for MZL.

“Relapsed/refractory MZL can be difficult to manage, making this an indication of high unmet medical need,” said Mohamed Zaki, MD, PhD, Chief Medical Officer of ADC Therapeutics. “As this investigator-initiated trial progresses, assuming the results continue to be positive, we plan to potentially pursue a regulatory pathway and compendia in parallel as soon as sufficient data are available.”

“Approximately 3,000 to 4,000 relapsed/refractory MZL patients are treated in the U.S. annually,” said Ameet Mallik, Chief Executive Officer of ADC Therapeutics. “Based on the initial data from University of Miami’s Phase 2 trial evaluating ZYNLONTA in relapsed/refractory MZL, we are encouraged by the potential opportunity in the 2L+ setting for patients with this rare disease.”

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.