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ADC Therapeutics Announces First Patient Dosed in Pivotal Phase 2 Portion of LOTIS 3 Clinical Trial of Loncastuximab Tesirine (Lonca) in Combination With Ibrutinib

July, 17, 2020

Combination is being evaluated in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) or mantle cell lymphoma (MCL)

Trial is intended to support the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA)

LAUSANNE, Switzerland--(BUSINESS WIRE)-- ADC Therapeutics SA (NYSE:ADCT), a late clinical-stage oncology-focused biotechnology company pioneering the development and commercialization of highly potent and targeted antibody drug conjugates (ADCs) for patients with hematological malignancies and solid tumors, today announced that the first patient has been dosed in the pivotal Phase 2 portion of LOTIS 3, a Phase 1/2 clinical trial evaluating loncastuximab tesirine (Lonca, formerly ADCT-402) in combination with ibrutinib in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) or mantle cell lymphoma (MCL).

“Based on the encouraging interim data Lonca and ibrutinib demonstrated in Phase 1, the trial was amended to a Phase 1/2 protocol intended to support the submission of a supplemental Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA),” said Jay Feingold, MD, PhD, Senior Vice President and Chief Medical Officer of ADC Therapeutics. “We are pleased to have dosed the first patient in the pivotal Phase 2 portion of this trial as we continue advancing Lonca as both a single agent and in combination with other therapies for patients with non-Hodgkin lymphoma. We are on track to file a BLA with the FDA for Lonca as monotherapy for the treatment of relapsed or refractory DLBCL in the second half of 2020.”

The 161-patient Phase 1/2 open-label, single-arm clinical trial is evaluating the safety and efficacy of Lonca in combination with ibrutinib in patients with relapsed or refractory DLBCL or MCL. The Phase 2 portion of the trial will enroll three cohorts: non-germinal center B-cell-like (non-GCB) DLBCL, GCB DLBCL and MCL.

“A significant proportion of patients with non-Hodgkin lymphoma relapse after treatment and their prognosis is poor, underscoring the need for new options for later-lines of therapy,” said Murali Janakiram, MD, MS, Assistant Professor of Medicine, University of Minnesota, Division of Hematology, Oncology, and Transplantation, and an investigator for the trial. “The combination of Lonca, a CD19-targeted ADC, and ibrutinib, a small-molecule inhibitor of Bruton’s tyrosine kinase, has shown synergy and I look forward to its continued evaluation in patients with relapsed or refractory DLBCL or MCL.”

Interim data from the Phase 1 portion of the Phase 1/2 clinical trial presented at the virtual 25th Congress of the European Hematology Association in June 2020 showed an overall response rate of 75.0% and complete response rate of 58.3% at the Lonca dose of 60 μg/kg, which is the selected dose for the Phase 2 portion of the trial, in combination with ibrutinib (560 mg/day) in patients with relapsed or refractory DLBCL or MCL. The combination has had a manageable toxicity profile, with the most common grade ≥3 treatment-emergent adverse events in ≥10% of patients being thrombocytopenia (20%) and anemia (12%).

About Loncastuximab Tesirine (Lonca)

Loncastuximab tesirine (Lonca, formerly ADCT-402) is an antibody drug conjugate (ADC) composed of a humanized monoclonal antibody directed against human CD19 and conjugated through a linker to a pyrrolobenzodiazepine (PBD) dimer cytotoxin. Once bound to a CD19-expressing cell, Lonca is designed to be internalized by the cell, following which the warhead is released. The warhead is designed to bind irreversibly to DNA to create highly potent interstrand cross-links that block DNA strand separation, thus disrupting essential DNA metabolic processes such as replication and ultimately resulting in cell death. CD19 is a clinically validated target for the treatment of B-cell malignancies.

Lonca is being evaluated in LOTIS 2, a pivotal Phase 2 clinical trial in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), and LOTIS 3, a pivotal Phase 1/2 trial in combination with ibrutinib in patients with relapsed or refractory DLBCL or mantle cell lymphoma (MCL).

About ADC Therapeutics

ADC Therapeutics SA (NYSE:ADCT) is a late clinical-stage oncology-focused biotechnology company pioneering the development and commercialization of highly potent and targeted antibody drug conjugates (ADCs) for patients with hematological malignancies and solid tumors. The Company develops ADCs by applying its decades of experience in this field and using next-generation pyrrolobenzodiazepine (PBD) technology to which ADC Therapeutics has proprietary rights for its targets. Strategic target selection for PBD-based ADCs and substantial investment in early clinical development have enabled ADC Therapeutics to build a deep clinical and research pipeline of therapies for the treatment of hematological and solid tumor cancers. The Company has multiple PBD-based ADCs in ongoing clinical trials, ranging from first in human to pivotal Phase 2 clinical trials, in the USA and Europe, and numerous preclinical ADCs in development.

Loncastuximab tesirine (Lonca, formerly ADCT-402), the Company’s lead product candidate, has been evaluated as a single-agent in a 145-patient pivotal Phase 2 clinical trial for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL) demonstrating a 48.3% interim overall response rate (ORR), which exceeded the target primary endpoint. Camidanlumab tesirine (Cami, formerly ADCT-301), the Company’s second lead product candidate, is being evaluated in a 100-patient pivotal Phase 2 clinical trial for the treatment of relapsed or refractory Hodgkin lymphoma (HL) after having shown an 86.5% ORR in HL patients in a Phase 1 clinical trial. The Company is also evaluating Cami as a novel immuno-oncology approach for the treatment of various advanced solid tumors.

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.

Forward-Looking Statements

This press release includes forward-looking statements, beliefs or opinions, including statements with respect to our business strategies and plans, competitive position and our objectives for future operations and our financial performance. These forward-looking statements involve known and unknown risks and uncertainties, including those described in our filings with the U.S. Securities and Exchange Commission, many of which are beyond our control and all of which are based on our management's current beliefs and expectations about future events. These forward-looking statements include all matters that are not historical facts. Forward-looking statements may and often do differ materially from actual results. No assurance can be given that such future results will be achieved. Such forward-looking statements contained in this document speak only as of the date of this document. We expressly disclaim any obligation or undertaking to update these forward-looking statements contained in this document to reflect any change in our expectations or any change in events, conditions, or circumstances on which such statements are based unless required to do so by applicable law. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements.

Availability of Other Information About ADC Therapeutics

Investors and others should note that ADC Therapeutics communicates with its investors and the public using its company website (https://adctherapeutics.com/), including but not limited to investor presentations, scientific presentations, Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that ADC Therapeutics posts on these channels and websites could be deemed to be material information. As a result, ADC Therapeutics encourages investors, the media and others interested in ADC Therapeutics to review the information that it posts on these channels, including ADC Therapeutics’ investor relations website, on a regular basis. This list of channels may be updated from time to time on ADC Therapeutics' investor relations website and may include other channels than the ones described above. The contents of ADC Therapeutics' website or these channels, or any other website that may be accessed from its website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended.

Investors
Amanda Hamilton
ADC Therapeutics
amanda.hamilton@adctherapeutics.com
Tel: +1 917-288-7023

EU Media
Alexandre Müller
Dynamics Group
amu@dynamicsgroup.ch
Tel: +41 (0) 43 268 3231

USA Media
Annie Starr
6 Degrees
astarr@6degreespr.com
Tel.: +1 973-768-2170

Source: ADC Therapeutics SA

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