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ADC Therapeutics Announces FDA Accepts Biologics License Application and Grants Priority Review for Loncastuximab Tesirine for Treatment of Relapsed or Refractory Diffuse Large B-cell Lymphoma Prescription Drug User Fee

Key Takeaway: ADC Therapeutics Announces FDA Accepts Biologics License Application and Grants Priority Review for Loncastuximab Tesirine for Treatment of Relapsed or Refractory Diffuse Large B-cell Lymphoma Drug User Fee Act target action date of May 21, 2021 Lausanne, Switzerland, Novembe

Full Press Release Details

ADC Therapeutics Announces FDA Accepts
Biologics License Application and Grants Priority Review for Loncastuximab Tesirine for Treatment of Relapsed or Refractory Diffuse
Large B-cell Lymphoma
Drug User Fee Act target action date of May 21, 2021
Lausanne, Switzerland, November
20, 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 that the U.S. Food and Drug Administration (FDA) has accepted its Biologics License
Application (BLA) for loncastuximab tesirine (Lonca) for the treatment of relapsed or refractory diffuse large B-cell lymphoma
(DLBCL) and granted priority review status. The FDA has set a Prescription Drug User Fee Act ("PDUFA") target date
"The FDA's acceptance
of our BLA and granting of priority review for Lonca is a tremendous accomplishment that brings ADC Therapeutics one step closer
to being able to offer patients with relapsed or refractory DLBCL a greatly needed new treatment option in 2021," said Chris
Martin, Chief Executive Officer of ADC Therapeutics. "We look forward to working with the FDA during its review of our BLA
submission for Lonca. Our organization remains focused on robust planning for a successful launch next year."
The BLA submission is based on
data from LOTIS 2, the pivotal Phase 2 multi-center, open-label, single-arm clinical trial evaluating the efficacy and safety
of Lonca in patients with relapsed or refractory DLBCL following two or more lines of prior therapy. In June 2020, the Company
presented maturing data from LOTIS 2 at the virtual 25th Congress of the European Hematology Association. As of the April 6th
cutoff date, Lonca demonstrated an overall response rate of 48.3% (70/145 patients) and a complete response rate of 24.1%
(35/145 patients). The tolerability profile was manageable with the most common grade 3 treatment-emergent adverse events
in 10% of patients being: neutropenia (25.5%) with low incidence of febrile neutropenia (3.4%), thrombocytopenia (17.9%),
GGT increase (16.6%) and anaemia (10.3%).
Data from subgroup analyses of
LOTIS 2 will be presented in a poster (abstract #1183) at the upcoming 62nd American Society for Hematology (ASH) Annual
Meeting on Saturday, December 5, 2020.
About Loncastuximab Tesirine
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, 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% overall response rate (ORR), which exceeded the target primary endpoint.
Lonca is also 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 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
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 in a Phase 1 clinical trial an 86.5% ORR
in HL patients at the dose selected for Phase 2. The Company is also evaluating Cami as a novel immuno-oncology approach for the
treatment of various advanced solid tumors.
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.
This press release contains statements
that constitute forward-looking statements. All statements other than statements of historical facts contained in this press release,
including statements regarding our future results of operations and financial position, business strategy, product candidates,
research pipeline, ongoing and planned preclinical studies and clinical trials, regulatory submissions and approvals, addressable
patient population, research and development costs, timing and likelihood of success, as well as plans and objectives of management
for future operations are forward-looking statements. Forward-looking statements are based on our management's beliefs and
assumptions and on information currently available to our management. Such statements are subject to risks and uncertainties,
and actual results may differ materially from those expressed or implied in the forward-looking statements due to various factors,
including those described in our filings with the U.S. Securities and Exchange Commission. 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 press release. We expressly disclaim any obligation or undertaking to update these forward-looking statements contained
in this press release 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.
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Last updated: Nov 20, 2020