ADC Therapeutics SA (NYSE: ADCT) today announced that initial data
from an investigator-initiated Phase 2 clinical trial evaluating
ZYNLONTA® (loncastuximab tesirine-lpyl) demonstrated a high
response rate in patients with relapsed/refractory (r/r) marginal
zone lymphoma (MZL).
The 50-patient single-arm, open-label Phase 2 multicenter study
is currently being conducted at the Sylvester Comprehensive Cancer
Center at University of Miami and City of Hope, and led by Izidore
Lossos, MD, Professor, Director, Lymphoma Program at the Sylvester
Comprehensive Cancer Center, University of Miami. This study is
evaluating the safety and efficacy of six cycles of ZYNLONTA across
18 weeks in patients with r/r MZL previously treated with ≥1 line
of systemic therapy (ClinicalTrials.gov identifier: NCT05296070).
As of the data cutoff date of March 30, 2024, 15 patients were
evaluable. Of these 15 patients evaluated, 13 achieved a complete
response (CR) and one patient achieved a partial response (PR). All
patients who achieved responses had maintained them at the time of
the data cutoff.
In this study, ZYNLONTA was generally well-tolerated and safety
was consistent with the known profile, with two patient
discontinuations. One patient discontinued after cycle 2 and a
second patient discontinued after cycle 4 due to a toxicity, which
fully resolved upon discontinuation of treatment. Both of these
patients remain in CR at 10 and 6 months, respectively.
These initial data were presented at the Lymphoma Research
Foundation’s 2024 Marginal Zone Lymphoma Scientific Workshop by the
trial’s lead investigator, Izidore Lossos, MD, Professor, Director,
Lymphoma Program at the Sylvester Comprehensive Cancer Center,
University of Miami.
“Achievement of complete response to treatment represents the
strongest predictor of positive outcomes in MZL so these initial
results are encouraging,” said Dr. Lossos. “We are now expanding
the number of sites to accelerate enrollment in this trial.”
MZL is a rare, indolent non-Hodgkin lymphoma (NHL) and the third
most common NHL subtype. There are few FDA-approved therapies for
MZL.
“Relapsed/refractory MZL can be difficult to manage, making this
an indication of high unmet medical need,” said Mohamed Zaki, MD,
PhD, Chief Medical Officer of ADC Therapeutics. “As this
investigator-initiated trial progresses, assuming the results
continue to be positive, we plan to potentially pursue a regulatory
pathway and compendia in parallel as soon as sufficient data are
available.”
“Approximately 3,000 to 4,000 relapsed/refractory MZL patients
are treated in the U.S. annually,” said Ameet Mallik, Chief
Executive Officer of ADC Therapeutics. “Based on the initial data
from University of Miami’s Phase 2 trial evaluating ZYNLONTA in
relapsed/refractory MZL, we are encouraged by the potential
opportunity in the 2L+ setting for patients with this rare
disease.”
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 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: the timing
and future results from the University of Miami’s
investigator-initiated trial in MZL, future FDA approval and/or
NCCN compendia inclusion and the market size and potential
opportunity; the effectiveness of the new commercial go-to-market
strategy, competition from new technologies, and the Company’s
ability to grow ZYNLONTA® revenue in the United States; Swedish
Orphan Biovitrum AB’s (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 timing and results
of the Company’s or its partners’ clinical trials including LOTIS 5
and 7, ADCT 601 and 602 as well as the Company’s early-stage
pipeline research projects, actions by the FDA or foreign
regulatory authorities with respect to the Company’s products or
product candidates; projected revenue and expenses; the Company’s
indebtedness, including Healthcare Royalty Management and Oaktree
and Blue Owl 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 10-K 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.
CONTACT:
Investors and MediaNicole RileyADC
TherapeuticsNicole.Riley@adctherapeutics.com+1 862-926-9040
ADC Therapeutics (NYSE:ADCT)
過去 株価チャート
から 5 2024 まで 6 2024
ADC Therapeutics (NYSE:ADCT)
過去 株価チャート
から 6 2023 まで 6 2024