ADC Therapeutics Doses First Patient in Phase 1b Clinical Trial of ZYNLONTA® (loncastuximab tesirine-lpyl) in Combination with Other Anti-cancer Agents

Rhea-AI Summary

ADC Therapeutics has announced the dosing of the first patient in the LOTIS-7 Phase 1b clinical trial, examining the efficacy of ZYNLONTA in combination with polatuzumab vedotin for treating relapsed or refractory B-cell non-Hodgkin lymphoma.

The trial aims to evaluate ZYNLONTA's safety and activity against various types of B-cell lymphomas, with a focus on achieving better responses in patients. This trial follows promising preclinical studies that indicated potential synergies with other therapies.

Positive

• First patient dosed in LOTIS-7 Phase 1b trial for ZYNLONTA.
• Trial explores combination therapy with polatuzumab vedotin, potentially enhancing treatment outcomes for B-cell lymphoma.
• ZYNLONTA has shown synergistic effects in preclinical studies.

Negative

• None.

Opportunity to enhance outcomes in patients with relapsed or refractory B-cell non-Hodgkin lymphoma

First arm of trial to evaluate ZYNLONTA in combination with polatuzumab vedotin

LAUSANNE, Switzerland--(BUSINESS WIRE)-- ADC Therapeutics SA (NYSE: ADCT) today announced the first patient has been dosed in LOTIS-7, a Phase 1b clinical trial evaluating ZYNLONTA® in combination with other anti-cancer agents in patients with relapsed or refractory B-cell non-Hodgkin lymphoma.

“As ZYNLONTA has been shown in preclinical studies to have synergistic or additive effects when combined with other anti-cancer therapies, we are eager to explore the potential of our differentiated CD19-directed ADC in combination with other established therapies,” said Joseph Camardo, MD, Chief Medical Officer of ADC Therapeutics. “We are excited by the opportunity to allow more lymphoma patients to achieve a response and benefit from the new combinations we are evaluating in LOTIS-7.”

The first arm of the LOTIS-7 open-label, multi-center, multi-arm Phase 1b trial will evaluate the safety and activity of ZYNLONTA in combination with polatuzumab vedotin in patients with relapsed or refractory B-cell non-Hodgkin lymphoma, including diffuse large B-cell lymphoma, high grade B-cell lymphoma, follicular lymphoma, mantle cell lymphoma, marginal zone lymphoma, and Burkitt lymphoma. The trial will include multiple arms in two parts – a dose escalation part and a dose expansion part. For more information about the LOTIS-7 trial, please visit www.clinicaltrials.gov (identifier NCT04970901).

ZYNLONTA is also being evaluated in the LOTIS clinical trial program as a therapeutic option in combination studies in other B-cell malignancies and earlier lines of therapy. For more information about the LOTIS trials, please visit https://www.adctherapeutics.com/our-pipeline/#lonca.

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) has 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 DLBCL not otherwise specified, 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 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.

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 biotechnology company improving the lives of those affected by 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 Therapeutics’ CD19-directed ADC ZYNLONTA (loncastuximab tesirine-lpyl) is approved by the FDA 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. Cami (camidanlumab tesirine) is being evaluated in a pivotal Phase 2 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 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 Twitter and LinkedIn.

ZYNLONTA® is a registered trademark of ADC Therapeutics SA.

Forward-Looking Statements

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Investors

Eugenia Litz

ADC Therapeutics

Eugenia.Litz@adctherapeutics.com

+44 7879 627205



Amanda Hamilton

ADC Therapeutics

amanda.hamilton@adctherapeutics.com

+1 917-288-7023



Media

Mary Ann Ondish

ADC Therapeutics

maryann.ondish@adctherapeutics.com

Tel.: +1 914-552-4625

Source: ADC Therapeutics SA

FAQ

What is the LOTIS-7 trial for ADC Therapeutics (ADCT)?

The LOTIS-7 trial is a Phase 1b clinical study evaluating ZYNLONTA in combination with polatuzumab vedotin for patients with relapsed or refractory B-cell non-Hodgkin lymphoma.

What is ZYNLONTA's mechanism of action?

ZYNLONTA is a CD19-directed antibody drug conjugate that binds to CD19-expressing cells, delivering a potent payload that induces cell death.

What types of lymphoma are being studied in the LOTIS-7 trial?

The trial includes various types of B-cell lymphomas, including diffuse large B-cell lymphoma, high grade B-cell lymphoma, and others.

What are the next steps after the LOTIS-7 trial?

Further evaluations of safety and efficacy will be conducted, and continued development of ZYNLONTA in combination with other therapies is planned.

What is the significance of the LOTIS-7 trial for ADCT stock?

The success of this trial could positively impact ADCT's stock by validating ZYNLONTA's effectiveness and expanding its market potential.