LAUSANNE, Switzerland, Dec. 30,
2024 /PRNewswire/ -- ADC Therapeutics SA (NYSE:
ADCT), a commercial-stage global leader and pioneer in the field of
antibody drug conjugates (ADCs), today announced the completion of
enrollment in LOTIS-5, the Phase
3 confirmatory trial evaluating
ZYNLONTA® (loncastuximab tesirine-lpyl) in
combination with rituximab (Lonca-R) in patients with relapsed or
refractory diffuse large B-cell lymphoma (r/r DLBCL). ZYNLONTA
previously received accelerated approval for the treatment of r/r
DLBCL after two or more lines of systemic therapy from the FDA in
2021.
"This milestone for LOTIS-5 brings
us a step closer to providing a potential combination treatment in
the 2L+ DLBCL setting that we believe will offer competitive
efficacy with favorable safety and a convenient dosing schedule,
well-suited for use in patients across care settings," said
Mohamed Zaki, MD, PhD, Chief Medical
Officer of ADC Therapeutics. "We anticipate sharing topline results
of the primary endpoint analysis by the end of 2025 once the
pre-specified number of events is reached and potentially
submitting our supplemental BLA to the U.S. Food and Drug
Administration (FDA) in the first quarter of 2026."
The randomized, open‐label, two‐part, two‐arm, multicenter study
is designed to confirm accelerated approval and may support
potential label expansion into 2L+ in combination with rituximab.
Twenty patients were enrolled in part 1 of a non-randomized safety
run‐in. As previously reported, the results showed an overall
response rate (ORR) by central review of 80% (16/20) with a
complete response (CR) rate of 50% (10/20) and no new safety
signals.
In part 2, patients with 2L+ DLBCL are randomized 1:1 to receive
fixed-dose ZYNLONTA with rituximab or
rituximab‐gemcitabine‐oxaliplatin (R‐GemOx). The primary endpoint
of LOTIS-5 is progression-free
survival with secondary endpoints of overall survival, ORR, CR rate
and duration of response as well as frequency and severity of
adverse events. Topline results of the primary endpoint analysis
are anticipated by the end of 2025 once the required number of
pre-specified events is reached followed by regulatory submission
to the FDA in Q1 2026 and potential approval in late 2026.
For more information about LOTIS-5, please
visit https://clinicaltrials.gov/ (identifier
NCT04384484).
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
the Company website at adctherapeutics.com and follow us 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 of the achievement of
the number of pre-specified events for LOTIS-5 and disclosure of full data read-out, the
results of the LOTIS-5 study, the
timing for regulatory submission of the supplemental BLA for
ZYNLONTA, the timing and FDA approval of the same, future market
acceptance and revenue for ZYNLONTA; the expected cash runway into
mid-2026 the Company's ability to grow
ZYNLONTA® revenue in the
United States; the ability of our partners to commercialize
ZYNLONTA® in foreign markets, the timing and amount
of future revenue and payments to us from such partnerships and
their ability to obtain regulatory approval for
ZYNLONTA® in foreign jurisdictions; the timing and
results of the Company's or its partners' research and development
projects or clinical trials including LOTIS
5 and 7 and ADCT 602 as well as early research in certain
solid tumors with different targets, linkers and payloads; the
timing and results of investigator-initiated trials including those
studying FL and MZL and the potential regulatory and/or compendia
strategy and the future opportunity; the timing and outcome of
regulatory submissions for the Company's products or product
candidates; actions by the FDA or foreign regulatory authorities;
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 comply with the
terms of the various agreements and 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 and current reports and filings with the
U.S. 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.
CONTACTS:
Investors
Marcy
Graham
ADC Therapeutics
Marcy.Graham@adctherapeutics.com
+1 650-667-6450
Media
Nicole Riley
ADC Therapeutics
Nicole.Riley@adctherapeutics.com
+1 862-926-9040
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