ADC Therapeutics Completes Enrollment in Phase 3 ZYNLONTA Trial

ADC Therapeutics Marks Milestone in Cancer Treatment Trials

ADC Therapeutics SA (NYSE: ADCT), a leader in the field of antibody drug conjugates (ADCs), has recently announced the important milestone of completing enrollment for its Phase 3 confirmatory trial, known as LOTIS-5. This trial evaluates ZYNLONTA (loncastuximab tesirine-lpyl) used in combination with rituximab for patients battling relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL).

Understanding LOTIS-5 Trial Details

The LOTIS-5 trial operates in a two-part structure: the first part involves a non-randomized safety run-in with twenty participants, who showcased an impressive overall response rate by central review of 80%. This included a complete response rate of 50%, showcasing the potential efficacy of ZYNLONTA combined with rituximab. The second part of the trial will randomize patients into two arms, receiving either fixed-dose ZYNLONTA with rituximab or the combination of rituximab-gemcitabine-oxaliplatin (R-GemOx).

Goals and Expectations from the Trial

The overarching goal of the LOTIS-5 study is to validate the accelerated approval already received by ZYNLONTA from the FDA in 2021. The primary endpoint of this study focuses on progression-free survival, while secondary endpoints will explore overall survival, the overall response rate, complete response rate, and the duration of response.

Key Insights from ADC Therapeutics' Leadership

Dr. Mohamed Zaki, the Chief Medical Officer of ADC Therapeutics, expressed optimism about the trial, stating that this achievement brings them closer to offering a promising combination treatment in the 2L+ DLBCL setting. He anticipates sharing topline results by the end of 2025, contingent upon reaching the pre-specified number of events.

What Makes ZYNLONTA Unique?

ZYNLONTA is a CD19-directed ADC that works effectively by targeting and binding to CD19-expressing cells. Once attached, ZYNLONTA is internalized, where enzymes release a potent payload designed to bind to DNA, ultimately causing cell cycle arrest and tumor death.

Regulatory Landscape for ZYNLONTA

Both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have granted approval for ZYNLONTA. This approval is crucial for adult patients who have undergone two or more lines of systemic therapy for r/r large B-cell lymphoma, marking a significant advance in the treatment of this challenging disease.

Future Outlook for ADC Therapeutics

Looking ahead, ADC Therapeutics remains committed to further developing ZYNLONTA in conjunction with other therapies across various B-cell malignancies and earlier treatment phases. The company is dedicated to advancing its proprietary ADC technology to enhance treatment outcomes for patients facing hematological malignancies and solid tumors.

Frequently Asked Questions

What is ZYNLONTA used for?

ZYNLONTA is used to treat patients with relapsed or refractory diffuse large B-cell lymphoma after they have undergone two or more lines of systemic therapy.

When are the expected results for the LOTIS-5 trial?

The topline results for the primary endpoint analysis of LOTIS-5 are expected to be shared by the end of 2025.

How does ZYNLONTA work?

ZYNLONTA utilizes a targeted approach, binding to CD19-expressing cells, which leads to internalization and eventual tumor cell death through its potent payload.

Who developed ZYNLONTA?

ZYNLONTA is developed by ADC Therapeutics, a pioneer in the antibody drug conjugate field.

What is ADC Therapeutics' focus for the future?

The company aims to further its ADC technology to improve treatment paradigms for patients with various malignancies and is looking into additional combination studies.

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