ADC Therapeutics SA (NYSE: ADCT) today announced abstracts on
ZYNLONTA® (loncastuximab tesirine-lpyl) have been accepted for
presentation at the 65th American Society of Hematology (ASH)
Annual Meeting, which will be held in San Diego, California
from December 9-12, 2023.
"We look forward to sharing insights from the
growing body of research supporting the clinical utility of
ZYNLONTA as a single agent and in combination with other treatments
at the 65th ASH Annual Meeting,” said Mohamed Zaki, MD, PhD, Chief
Medical Officer of ADC Therapeutics. “In addition, we are
encouraged by the initial results of an investigator-initiated
Phase 2 study evaluating ZYNLONTA in combination with rituximab in
patients with relapsed or refractory follicular lymphoma. The
combination was well tolerated with a 95% overall response rate at
week 12 and at week 21, an 86% metabolic complete response rate. We
look forward to additional details to be shared during the oral
presentation.”
Details of the oral presentation of the investigator-initiated
study:
Title: Limited Duration Loncastuximab Tesirine
with Rituximab Induces High Complete Metabolic Response Rate in
High-Risk Relapsed/Refractory Follicular Lymphoma – A Phase 2
StudyAbstract: 984Session: 623.
Mantle Cell, Follicular, and Other Indolent B Cell Lymphomas:
Clinical and Epidemiological: Targeted TherapyDate and
Time: Monday, December 11, 2023; 5:45 PM
PTLocation: Manchester Grand Hyatt San Diego,
Grand Hall CPresenter: Juan Pablo Alderuccio,
MD
Details of selected poster presentations:
Title: Early and Sustained Circulating Tumor
DNA Response Dynamics after Loncastuximab Tesirine for
Relapsed/Refractory Diffuse Large B-Cell
LymphomaAbstract: 3133Session:
627. Aggressive Lymphomas: Clinical and Epidemiological; Poster II
PresentationsDate and Time: Sunday, December 10,
2023; 6:00 PM - 8:00 PM PT
Title: A Global Study of Novel Agents in
Paediatric and Adolescent Relapsed and Refractory B-Cell
Non-Hodgkin Lymphoma (Glo-BNHL)Abstract:
3097Session: 626. Aggressive Lymphomas:
Prospective Therapeutic Trials; Poster II PresentationsDate
and Time: Sunday, December 10, 2023; 6:00 PM - 8:00 PM
PT
Title: Loncastuximab Tesirine Demonstrated
Substantial Single-agent Efficacy and Manageable Safety Profile in
Heavily Pretreated Chinese Patients with Relapsed or Refractory
(R/R) Diffuse Large B-Cell Lymphoma
(DLBCL)Abstract: 4469Session:
626. Aggressive Lymphomas: Prospective Therapeutic Trials; Poster
III PresentationsDate and Time: Monday, December
11, 2023; 6:00 PM - 8:00 PM PT
Posters will be available in the poster exhibit
halls (Halls G-H) at the San Diego Convention Center on December
10, 2023, from 9:00 AM - 8:00 PM PT (Poster II Presentations) and
on December 11, 2023, from 9:00 AM - 8:00 PM PT (Poster III
Presentations). Presenters planning to attend in person are
expected to present during the final two hours of the noted viewing
time. Presentations will also be available on a virtual
platform.
The abstracts are available through the ASH online meeting
program.
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) and
the European Medicines Agency (EMA) have
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 and in the European Union under
conditional 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. Please
see full prescribing information including important safety
information about ZYNLONTA at www.ZYNLONTA.com.
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 global leader and pioneer in the field of antibody
drug conjugates (ADCs). The Company is advancing its proprietary
ADC technology to transform the treatment paradigm for patients
with hematologic malignancies and solid tumors.
ADC Therapeutics’ CD19-directed ADC ZYNLONTA
(loncastuximab tesirine-lpyl) received accelerated approval by the
FDA and conditional approval from the European Commission 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 and in earlier lines
of therapy. In addition to ZYNLONTA, 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 LinkedIn.
ZYNLONTA® is a registered trademark of ADC Therapeutics
SA.
Forward-Looking Statements
This press release contains forward-looking
statements within the meaning of the safe harbor provisions of the
Private Securities Litigation Reform Act of 1995. In some cases you
can identify forward-looking statements by terminology such as
“may”, “will”, “should”, “would”, “expect”, “intend”, “plan”,
“anticipate”, “believe”, “estimate”, “predict”, “potential”,
“seem”, “seek”, “future”, “continue”, or “appear” or the negative
of these terms or similar expressions, although not all
forward-looking statements contain these identifying words.
Forward-looking statements are subject to certain risks and
uncertainties that can cause actual results to differ materially
from those described. Factors that may cause such differences
include, but are not limited to: uncertainties related to the
impact of data presented at the 65th ASH Annual Meeting and future
results, the success of the Company’s updated corporate strategy
including operating efficiencies, capital deployment and portfolio
prioritization; the Company’s ability to achieve the decrease in
total operating expenses for 2023 and 2024, the expected cash
runway into the middle of 2025, the effectiveness of the new
commercial go-to-market strategy, competition from new
technologies, the Company’s ability to continue to commercialize
ZYNLONTA® in the United States and future revenue from the same;
Swedish Orphan Biovitrum AB (Sobi®) ability to successfully
commercialize ZYNLONTA® in the European Economic Area and market
acceptance, adequate reimbursement coverage, and future revenue
from the same; approval by the NMPA of the BLA for ZYNLONTA in
China submitted by Overland ADCT BioPharma and future revenue from
the same, our strategic partners’, including Mitsubishi Tanabe
Pharma Corporation, ability to obtain regulatory approval for
ZYNLONTA® in foreign jurisdictions, and the timing and amount of
future revenue and payments to us from such partnerships; the
Company’s ability to market its products in compliance with
applicable laws and regulations; the Company’s expectations
regarding the impact of the Infrastructure Investment and Jobs Act;
the timing and results of the Company’s or its partners’ research
projects or clinical trials including LOTIS 5 and 7, ADCT 901, 601
and 602, the impact, if any, from discontinuation of the LOTIS-9
study, actions by the FDA or foreign regulatory authorities with
respect to the Company’s products or product candidates, the timing
and outcome of regulatory submissions for the Company’s products or
product candidates; the ability to complete clinical trials on
expected timelines, if at all; projected revenue and expenses; the
Company’s indebtedness, including Healthcare Royalty Management and
Blue Owl and Oaktree facilities, and the restrictions imposed on
the Company’s activities by such indebtedness, the ability to repay
such indebtedness and the significant cash required to service such
indebtedness; and the Company’s ability to obtain financial and
other resources for its research, development, clinical, and
commercial activities. Additional information concerning these and
other factors that may cause actual results to differ materially
from those anticipated in the forward-looking statements is
contained in the “Risk Factors” section of the Company's Annual
Report on Form 20-F and in the Company's other periodic reports and
filings with the Securities and Exchange Commission. These
statements involve known and unknown risks, uncertainties and other
factors that may cause actual results, performance, achievements or
prospects to be materially different from any future results,
performance, achievements or prospects expressed in or implied by
such forward-looking statements. The Company cautions investors not
to place undue reliance on the forward-looking statements contained
in this document. The Company undertakes no obligation to revise or
update these forward-looking statements to reflect events or
circumstances after the date of this press release, except as
required by law.
CONTACTS:
InvestorsEugenia LitzADC
TherapeuticsEugenia.Litz@adctherapeutics.com +44 7879 627205+1
908-723-2350
MediaNicole RileyADC
TherapeuticsNicole.Riley@adctherapeutics.com +1 862-926-9040
ADC Therapeutics (NYSE:ADCT)
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