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ADC Therapeutics Announces Maturing Data from Pivotal Phase 2 Clinical Trial and Phase 1/2 Combination Clinical Trial of Loncastuximab Tesirine (Lonca) in Patients with Relapsed or Refractory Diffuse Large B-cell Lymphom

Key Takeaway: ADC Therapeutics Announces Maturing Data from Pivotal Phase 2 Clinical Trial and Phase 1/2 Combination Clinical Trial of Loncastuximab Tesirine (Lonca) in Patients with Relapsed or Refractory Diffuse Large B-cell Lymphoma Lonca demonstrated an overall response rate of 48.3% a

Full Press Release Details

ADC Therapeutics Announces Maturing Data
from Pivotal Phase 2 Clinical Trial and Phase 1/2 Combination Clinical Trial of Loncastuximab Tesirine (Lonca) in Patients with
Relapsed or Refractory Diffuse Large B-cell Lymphoma
Lonca demonstrated an overall response
rate of 48.3% and complete response rate of 24.1% in the pivotal Phase 2 single-agent trial
Interim results of the Phase 1/2 trial
of Lonca in combination with ibrutinib show an encouraging overall response rate of 75.0% and complete response rate of 58.3% at
the recommended Phase 2 Lonca dose
Company to host conference call today,
June 12, 2020, at 8:30 a.m. EDT, to highlight data presented at the Virtual 25th EHA Annual Congress
Lausanne, Switzerland - June 12, 2020 - ADC
Therapeutics SA (NYSE:ADCT), a clinical-stage oncology-focused biotechnology company leading the development and commercialization
of next-generation antibody drug conjugates (ADCs) with highly potent and targeted pyrrolobenzodiazepine (PBD) dimer technology,
today announced maturing data from LOTIS 2, a pivotal Phase 2 clinical trial of loncastuximab tesirine (Lonca, formerly ADCT-402)
in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), including an overall response rate of 48.3%, a complete
response rate of 24.1% and manageable toxicity. The Company also announced interim results from LOTIS 3, a Phase 1/2 clinical trial
of Lonca combined with ibrutinib, which highlight the potential of Lonca to advance into earlier lines of therapy in combination
with other therapies. The data are being presented in an oral presentation and e-Poster at the virtual 25th Congress
of the European Hematology Association (EHA25).
"Our two presentations at EHA25 highlight Lonca's
potential as both a single agent and in combination with other therapies for patients with non-Hodgkin lymphoma," said Jay
Feingold, MD, PhD, Senior Vice President and Chief Medical Officer of ADC Therapeutics. "In LOTIS 2, Lonca demonstrated important
anti-tumor activity and durability, as well as manageable toxicities, across a broad population of hard-to- treat, relapsed or
refractory DLBCL patients, including patients with poor prognosis, those who never responded to prior therapy and those who received
prior stem cell transplant."
"We are pleased to be on track to file a Biologics License
Application (BLA) with the U.S. Food and Drug Administration for Lonca for the treatment of relapsed or refractory DLBCL in the
second half of 2020," said Chris Martin, Chief Executive Officer of ADC Therapeutics. "If approved, we look forward
to launching Lonca in mid-2021. We are also planning to initiate LOTIS 5, a post-marketing confirmatory clinical trial of Lonca
in combination with rituximab, which we believe will support a supplemental BLA for Lonca to be used as a second-line therapy for
the treatment of relapsed or refractory DLBCL."
Oral Presentation of Initial Results of Lonca Pivotal Phase
2 Clinical Trial (Abstract S233)
LOTIS 2, a Phase 2, multi-center, open-label, single-arm clinical
trial, is evaluating the efficacy and safety of Lonca in patients with relapsed or refractory DLBCL following 2 lines of prior
Patients received 30-minute intravenous infusions of Lonca once
every three weeks at a dose of 150 g/kg for the first two cycles, followed by 75 g/kg for subsequent cycles for up to one
year or until disease progression, unacceptable toxicity, or other discontinuation criteria, whichever occurred first. As of the
data cut-off date of April 6, 2020, 145 patients were enrolled and received a mean of 4.3 cycles of Lonca (range: 1-15).
"Despite recent advances in DLBCL treatment, outcomes for
patients with relapsed or refractory disease remain poor," said Carmelo Carlo-Stella, MD, Professor of Hematology, Humanitas
University, Section Chief, Lymphoid Malignancies, Humanitas Cancer Center, and an investigator for the trial. "The substantial
single-agent anti-tumor activity Lonca has demonstrated in patients with relapsed or refractory DLBCL who failed established therapies
underscores the potential of this CD19-targeted, PBD-based ADC to fill a critical unmet need."
e-Poster with Interim Results of Phase 1/2 Clinical Trial
of Lonca Combined With Ibrutinib (Abstract EP1284)
LOTIS 3, a Phase 1/2 open-label, single-arm dose escalation and
dose expansion clinical trial, is evaluating the safety and efficacy of Lonca in combination with ibrutinib in patients with relapsed
or refractory DLBCL or mantle cell lymphoma (MCL). Lonca is administered as 30-minute intravenous infusions using a standard 3+3
dose escalation design at doses of 60 or 90 g/kg. Patients receive Lonca every three weeks for the first two doses, with concurrent
fixed-dose ibrutinib (560 mg/day, oral) for up to one year. As of the data cut-off date of April 6, 2020, 25 patients have been
enrolled, including 23 patients with DLBCL and two patients with MCL, and 18 patients were evaluable for antitumor activity. The
trial continues to enroll patients.
Key interim data from the Phase 1 portion of the trial include:
"As patients with relapsed or refractory DLBCL or MCL have
a poor prognosis and limited salvage treatment options, it is important to explore the potential for combinations of drugs with
different mechanisms of action to increase clinical activity compared to either agent alone," said Julien Depaus, MD, Department
of Hematology, CHU UCL Namur. "Based on synergies demonstrated in preclinical research and the interim results of the Phase
1 portion of this clinical trial, I believe the combination of Lonca and ibrutinib warrants further evaluation as a treatment option
for patients with relapsed or refractory DLBCL or MCL."
Conference Call and Webcast
ADC Therapeutics will host a live conference call and webcast
today, Friday, June 12, 2020, at 8:30 a.m. EDT, to highlight the data presented at EHA25. To access the call, please dial 833-526-8381
(domestic) or +41 225 805 976 (international) and request to join the ADC Therapeutics conference call. A live webcast of the
presentation will be available on the Investors section of the ADC Therapeutics website at www.adctherapeutics.com.
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 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 suffering from 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 with significant unmet
need. 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 in a 145-patient pivotal Phase 2 clinical
trial for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL) that showed 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 (Biop le), 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,
Last updated: Jun 12, 2020