Full Press Release Details
ADC Therapeutics Announces Updated Clinical
Data on Lead Antibody Drug Conjugate Programs Loncastuximab Tesirine (Lonca) and Camidanlumab Tesirine (Cami) Presented at 62nd
American Society of Hematology Annual Meeting
Lonca LOTIS 2 subgroup data include updated
median duration of response of 12.58 months
LOTIS 3 interim results highlight potential
of Lonca in combination with ibrutinib in relapsed or refractory diffuse large B-cell lymphoma and mantle cell lymphoma patients
Preliminary pivotal Cami data demonstrate
83% overall response rate and no new safety signals in patients with relapsed or refractory Hodgkin lymphoma
Company to host conference call and webcast
Lausanne, Switzerland, December 7, 2020 - 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 updated clinical data from its two lead programs, loncastuximab tesirine (Lonca) and camidanlumab tesirine (Cami), which
were presented at the 62nd American Society of Hematology (ASH) Annual Meeting.
"The encouraging data presented at the 2020 ASH Annual
Meeting reinforce the significant progress we have made with our PBD-based ADCs for patients with hematological malignancies,"
said Jay Feingold, MD, PhD, Senior Vice President and Chief Medical Officer of ADC Therapeutics. "The U.S. Food and Drug
Administration recently accepted our Biologics License Application for Lonca for the treatment of relapsed or refractory diffuse
large B-cell lymphoma and granted priority review status with a Prescription Drug User Fee Act (PDUFA) target date of May 21, 2021,
based on the data from our pivotal LOTIS 2 clinical trial. As we rigorously prepare for potential approval and launch in 2021,
we look forward to continuing to evaluate the potential of Lonca, as a single agent and in combination, in heavily pre-treated
patients, in earlier lines of therapy and in additional indications such as follicular lymphoma. As for Cami, our pivotal Phase
2 trial in Hodgkin lymphoma is now more than 50 percent enrolled, and the preliminary data presented at ASH highlight its potential
to address an unmet need in heavily pretreated Hodgkin lymphoma patients."
Lonca LOTIS 2 Subgroup Analysis (Abstract 1183)
In LOTIS 2, a single-arm, open-label, 145-patient Phase 2 clinical
trial in patients with relapsed or refractory DLBCL who had failed 2 established therapies, Lonca demonstrated substantial
antitumor activity and an acceptable safety profile. Updated results, including analysis of response in subgroups with high risk
of poor prognosis, were presented in a poster at ASH 2020 by Paolo F. Caimi, MD, University Hospitals Cleveland Medical Center
and Case Comprehensive Cancer Center, Case Western Reserve University.
Key data at the August 6, 2020, data cut include:
Lonca LOTIS 3 Interim Results (Abstract 2099)
LOTIS 3, a Phase 1/2, two-part, open-label, single-arm clinical
trial that is intended to support the submission of a Biologics License Application, is evaluating Lonca in combination with ibrutinib
in patients with relapsed or refractory DLBCL or mantle cell lymphoma (MCL). Updated interim data for patients receiving the 60
g/kg Phase 2 dose of Lonca every three weeks and ibrutinib 560 mg/day were presented in a poster at ASH 2020. As of the
data cut-off date of August 20, 2020, 37 patients had received the Phase 2 dose and 35 were evaluable for efficacy.
"The need for a later line of therapy that is both effective
and tolerable is underscored by the significant number of patients with DLBCL or MCL who relapse after treatment and have a poor
prognosis," said Julien Depaus, MD, Department of Hematology, CHU UCL Namur. "It is very encouraging to see that Lonca
in combination with ibrutinib, at the Phase 2 dose identified as the maximum tolerated dose in the initial Phase 1 portion of the
clinical trial, continues to demonstrate antitumor activity and manageable toxicity in patients with relapsed or refractory DLBCL
Cami Pivotal Phase 2 Preliminary Results (Abstract 474)
Cami is being evaluated in a multicenter, open-label, single-arm,
100-patient Phase 2 clinical trial in patients with relapsed or refractory Hodgkin lymphoma (HL) who have received 3 prior
lines of treatment ( 2 lines if ineligible for hematopoietic stem cell transplantation, HSCT) including prior treatment with
brentuximab vedotin and a checkpoint inhibitor. Preliminary efficacy and safety data were reported in an oral presentation at ASH
2020. As of the data cut-off date of August 24, 2020, 51 patients had been treated with Cami and the median number of Cami cycles
"Patients with relapsed or refractory HL who do not respond,
or experience disease progression after initial response, to treatments such as brentuximab vedotin and PD-1 blockade have limited
therapeutic options," said Alex Herrera, MD, Assistant Professor, Department of Hematology and Hematopoietic Cell Transplantation
at City of Hope Medical Center. "The encouraging antitumor activity Cami has demonstrated as a single agent and its safety
profile, which has been consistent with the Phase 1 trial, warrant the continued evaluation of this CD25-targeted ADC in relapsed
or refractory HL patients."
ADC Therapeutics anticipates reporting interim results from the
pivotal Phase 2 trial of Cami in HL in the first half of 2021. A Phase 1b clinical trial of Cami as monotherapy or in combination
with pembrolizumab is currently enrolling patients with selected advanced solid tumors.
Conference Call and Webcast
ADC Therapeutics will host a live conference call and webcast
today, December 7, 2020, at 8 a.m. ET, to highlight the Lonca and Cami data presented at ASH. The event will feature presentations
from ADC Therapeutics management and key opinion leader Mehdi Hamadani, MD, Professor of Internal Medicine at the Medical College
of Wisconsin, Division of Hematology and Oncology. To access the conference call, please dial (833) 303-1198 (domestic) or +1 914
987-7415 (international) and provide the pin number 1486164. A live webcast of the presentation will be available on the Investors
section of the ADC Therapeutics website at www.adctherapeutics.com. The archived webcast will be available on the ADC Therapeutics
website after the completion of the event.
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.
A Biologics License Application for Lonca for the treatment of
relapsed or refractory diffuse large B-cell lymphoma (DLBCL) is currently under review with the U.S. Food and Drug Administration
(FDA) and has been granted priority review status. The FDA has set a Prescription Drug User Fee Act target date of May 21, 2021.
Lonca is being evaluated in LOTIS 3, a Phase 1/2 clinical trial in combination with ibrutinib in patients with relapsed or refractory
DLBCL or mantle cell lymphoma, and LOTIS 5, a Phase 3 confirmatory clinical trial in combination with rituximab in patients with
relapsed or refractory DLBCL.
About Camidanlumab Tesirine (Cami)
Camidanlumab tesirine (Cami, formerly ADCT-301) is an antibody
drug conjugate (ADC) comprised of a monoclonal antibody that binds to CD25 (HuMax -TAC, licensed from Genmab A/S), conjugated
to the pyrrolobenzodiazepine (PBD) dimer payload, tesirine. Once bound to a CD25-expressing cell, Cami is internalized into the
cell where enzymes release the PBD-based warhead killing the cell. This applies to CD25-expressing tumor cells, and also to CD25-expressing
Tregs. The intra-tumoral release of its PBD warhead may also cause bystander killing of neighboring tumor cells and PBDs have also
been shown to induce immunogenic cell death. All of these properties of Cami may enhance immune-mediated anti-tumor activity. Cami
is being evaluated in a pivotal Phase 2 clinical trial in patients with relapsed or refractory Hodgkin lymphoma (HL), as well as
in a Phase 1a/1b clinical trial in patients with relapsed or refractory HL and non-Hodgkin lymphoma and a Phase 1b clinical trial
as monotherapy and in combination with pembrolizumab in solid tumors.
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 confirmatory Phase 3 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