ADC Therapeutics Announces Validation of its Marketing Authorization Application by the European Medicines Agency for ZYNLONTA®
October 29 2021 - 7:15AM
Business Wire
Application supported by data from pivotal
LOTIS-2 trial in adult patients with relapsed or refractory diffuse
large B-cell lymphoma
Milestone achieved in commitment to make
ZYNLONTA widely available to patients in need
ADC Therapeutics SA (NYSE: ADCT), a commercial-stage
biotechnology company improving the lives of those affected by
cancer with its next-generation, targeted antibody drug conjugates
(ADCs) for patients with hematologic malignancies and solid tumors,
today announced its Marketing Authorization Application (MAA) for
ZYNLONTA®, a CD19-targeted ADC for the treatment of relapsed or
refractory diffuse large B-cell lymphoma (DLBCL), has been
validated by the European Medicines Agency (EMA). Validation of the
application enables the evaluation process by the EMA’s Committee
for Medicinal Products for Human Use (CHMP) to begin.
“We continue to gain momentum with the U.S. ZYNLONTA launch, and
we are pleased to be making progress in Europe with the submission
and validation of our MAA,” said Chris Martin, PhD, Chief Executive
Officer of ADC Therapeutics. “This is a significant step forward in
our commitment to making ZYNLONTA available to as many patients as
may benefit.”
In April 2021, the U.S. Food and Drug Administration (FDA)
granted accelerated approval to ZYNLONTA as the first and only
CD19-targeted ADC as a single-agent treatment for adult patients
with relapsed or refractory DLBCL after two or more lines of
systemic therapy. In September 2021, the European Commission
granted Orphan Drug Designation to ZYNLONTA for the treatment of
DLBCL.
The MAA is supported by data from LOTIS-2, a large (n=145) Phase
2 multinational, single-arm clinical trial of ZYNLONTA for the
treatment of adult patients with relapsed or refractory 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 LOTIS-2 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%).
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. The trial included a broad spectrum of heavily
pre-treated patients (median three prior lines of therapy) with
difficult-to-treat disease, including 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 transplant and CAR-T therapy prior to their treatment
with ZYNLONTA. 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.
ZYNLONTA is also being evaluated as a therapeutic option in
combination studies in other B-cell malignancies and earlier lines
of therapy.
About ADC Therapeutics
ADC Therapeutics (NYSE: ADCT) is a commercial-stage
biotechnology company improving the lives of those affected by
cancer 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 development 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, ADC Therapeutics
has multiple 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.
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Investors
Eugenia Litz ADC Therapeutics Eugenia.Litz@adctherapeutics.com
Tel.: +44 7879 627205
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 Mary Ann Ondish ADC Therapeutics
maryann.ondish@adctherapeutics.com Tel.: +1 914-552-4625
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