ADC Therapeutics SA (NYSE: ADCT) today announced that two ZYNLONTA®
(loncastuximab tesirine-lpyl) abstracts have been accepted for
presentation at the Eleventh Annual Meeting of the Society of
Hematologic Oncology (SOHO 2023), which will be held in Houston,
Texas from September 6-9, 2023.
“We are very pleased with the progress of our
ongoing ZYNLONTA development programs. For LOTIS-5, the Phase
3 study evaluating the combination of ZYNLONTA with
rituximab, we are encouraged by the updated safety run-in results
being presented at SOHO 2023. The data show signs of durable
responses in patients with relapsed or refractory diffuse large
B-cell lymphoma and, importantly, no new safety signals,” said
Mohamed Zaki, MD, PhD, Chief Medical Officer of ADC Therapeutics.
“As for the LOTIS-7 Phase 1b clinical trial that is
evaluating ZYNLONTA in combination with other anticancer
agents, the bispecific arms are actively enrolling patients, and we
will be sharing more details about the study at SOHO 2023.”
Michal Kwiatek, MD, PhD, Medical Director,
Centrum Medyczne Pratia Poznan, Skorzewo, Poland and lead author of
the LOTIS-5 abstract, said, “Although still early, the updated data
from the safety run-in of the LOTIS-5 study look promising. The
combination of ZYNLONTA and rituximab is a systemic
chemo-free regimen with a fixed treatment duration, making it an
appealing alternative to continuous therapies.”
LOTIS-5 Safety Run-In Results:
LOTIS-5 is a Phase 3, randomized, open‐label,
two‐part, two‐arm, multicenter study of loncastuximab tesirine in
combination with rituximab (Lonca-R) in patients with relapsed or
refractory diffuse large B-cell lymphoma (DLBCL). It is the
confirmatory trial for accelerated approval for 3L+ and would also
support potential label expansion into 2L+ in combination with
rituximab. Twenty patients were enrolled in part 1 of a
non-randomized safety run‐in. In part 2, approximately 330 patients
will be randomized 1:1 to receive fixed-dose Lonca‐R or
rituximab‐gemcitabine‐oxaliplatin (R‐GemOx).
The 20 patients in the safety run‐in were a
median age of 74.5 years and had previously received a median of
five cycles of Lonca-R and one previous therapy. As of the April
10, 2023, data cutoff:
- Seven patients completed treatment and five continue in
follow-up.
- The overall response rate by central review was 16/20 (80%). A
total of 10/20 (50%) and 6/20 (30%) patients attained complete and
partial response, respectively.
- The median duration of response was 8.0 months and the median
progression-free survival was 8.3 months.
- A total of 11 (55%) patients had
grade ≥3 treatment-emergent adverse events (TEAEs). The most common
grade ≥3 TEAEs were increased gamma-glutamyltransferase (5 patients
[25%]) and neutropenia (3 patients [15%]).
These data will be presented in the following
poster:
Updated Results of the Safety Run-in of the
Phase 3 LOTIS-5 Trial: Novel Combination of Loncastuximab Tesirine
With Rituximab (Lonca-R) Versus Immunochemotherapy in Patients With
R/R DLBCLDate and Time: Wednesday, September 6, 2023, 6:00-7:00PM
CTLocation: George R. Brown Convention Center, Level 3, Grand
BallroomPoster Number: ABCL-515
LOTIS-7:
Details of ADC Therapeutics’ poster highlighting the LOTIS-7
trial design are as follows:
Phase Ib Open-Label Study of Loncastuximab
Tesirine in Combination With Other Anticancer Agents in Patients
With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma
(LOTIS-7)Date and Time: Wednesday, September 6, 2023, 6:00-7:00PM
CTLocation: George R. Brown Convention Center, Level 3, Grand
BallroomPoster Number: ABCL-134
LOTIS-7 is a multicenter and multi-arm study
that will enroll approximately 200 patients with relapsed or
refractory B-cell non-Hodgkin lymphoma in part 1 (dose escalation
in approximately 60 patients) and part 2 (dose expansion in
approximately 120 patients). Dosing arms
include ZYNLONTA (loncastuximab tesirine-lpyl) plus
polatuzumab vedotin, as well as ZYNLONTA (loncastuximab
tesirine-lpyl) plus glofitamab and mosunetuzumab, t-cell-engaging
bispecific monoclonal antibodies (BsAbs).
The bispecific combination arms of the LOTIS-7
trial are now actively enrolling patients with DLBCL, including
transformed follicular lymphoma (FL), high-grade B-cell lymphoma
(HGBCL), follicular lymphoma (FL) and marginal zone lymphoma (MZL).
Combining these agents with different mechanisms of action has the
potential to have increased activity compared to either agent
alone.
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. For
complete prescribing information including important safety
information, please see
https://www.adctherapeutics.com/wp-content/uploads/2022/10/ZYLONTA-PI_October-2022_LOCKED.pdf.
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. 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: future timing, results and
outcomes of the LOTIS 5 and 7 studies; the success of the Company’s
updated corporate strategy including operating efficiencies,
capital deployment and portfolio prioritization; the Company’s
ability to achieve the 2023 net product sales guidance for
ZYNLONTA® and 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’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 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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