ADC Therapeutics Receives Orphan Drug Designation in Europe for ZYNLONTA®
September 13 2021 - 7:15AM
Business Wire
ADC Therapeutics SA (NYSE: ADCT), a
commercial-stage biotechnology company leading the development of
novel antibody drug conjugates (ADCs) to treat hematological
malignancies and solid tumors, today announced that the European
Commission has granted Orphan Drug Designation to ZYNLONTA®, a
CD19-targeted ADC, for the treatment of diffuse large B-cell
lymphoma (DLBCL).
“This Orphan Drug Designation recognizes the significant unmet
need in patients with diffuse large B-cell lymphoma in the European
Union (EU),” said Joseph Camardo, MD, Senior Vice President and
Chief Medical Officer of ADC Therapeutics. “We are committed to
providing global access to ZYNLONTA for as many patients as may
benefit. This designation is an important step in our collaboration
with EMA for our marketing authorization in the EU.”
Orphan Drug Designation in the EU is granted by the European
Commission based on a positive opinion issued by the EMA Committee
for Orphan Medicinal Products (COMP). It is intended to encourage
the development of drugs that may provide significant benefit to
patients suffering from rare, life-threatening diseases. If
approved for marketing, this designation will provide ten years of
marketing exclusivity and also provide special incentives for
sponsors, including eligibility for protocol assistance and
possible exemptions or reductions in certain regulatory fees.
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 diffuse large B-cell
lymphoma (DLBCL) not otherwise specified (NOS), DLBCL arising from
low-grade lymphoma and also high-grade B-cell lymphoma. 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.
The FDA approval was based on data from LOTIS-2, a large (n=145)
Phase 2 multinational, single-arm clinical trial of ZYNLONTA for
the treatment of adult patients with r/r DLBCL following two or
more prior lines of systemic therapy. The trial included a broad
spectrum of heavily pre-treated patients (median three prior lines
of therapy) with very difficult to treat disease, including
patients with high-grade B-cell lymphoma. The trial enrolled
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
transplants and CAR-T therapy prior to their treatment with
ZYNLONTA. Results from the trial demonstrated an overall response
rate (ORR) of 48.3% (70/145 patients), which included a complete
response (CR) rate of 24.1% (35/145 patients) and a partial
response (PR) rate of 24.1% (35/145 patients). Patients had a
median time to response of 1.3 months. At the most recent data
cut-off for patients enrolled in the trial, the median duration of
response (mDoR) was 13.4 months. In a pooled safety population the
most common adverse reactions (≥20%) were thrombocytopenia,
gamma-glutamyltransferase increased, neutropenia, anemia,
hyperglycemia, transaminase elevation, fatigue, hypoalbuminemia,
rash, edema, nausea and musculoskeletal pain. In LOTIS-2, the most
common (≥10%) grade ≥3 treatment-emergent adverse events were
neutropenia (26.2%), thrombocytopenia (17.9%),
gamma-glutamyltransferase increased (17.2%) and anemia (10.3%).
ZYNLONTA is being evaluated in combination for earlier lines of
therapy and as a monotherapy in other B-cell malignancies.
About ADC Therapeutics
ADC Therapeutics (NYSE: ADCT) is a commercial-stage
biotechnology company improving the lives of cancer patients 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 late-stage clinical trials
in combination with other agents. Cami (camidanlumab tesirine) is
being evaluated in a late-stage clinical 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,
the Company has multiple PBD-based 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210913005096/en/
Investors Eugenia Litz ADC Therapeutics
Eugenia.Litz@adctherapeutics.com +44 7879 627205
Amanda Hamilton ADC Therapeutics
amanda.hamilton@adctherapeutics.com +1 917-288-7023
EU Media Alexandre Müller Dynamics Group
amu@dynamicsgroup.ch +41 (0) 43 268 3231
USA Media Mary Ann Ondish ADC Therapeutics
maryann.ondish@adctherapeutics.com +1 914-552-4625
ADC Therapeutics (NYSE:ADCT)
Historical Stock Chart
From Mar 2024 to Apr 2024
ADC Therapeutics (NYSE:ADCT)
Historical Stock Chart
From Apr 2023 to Apr 2024