ADC Therapeutics SA (NYSE: ADCT) today announced initial results
from an investigator-initiated Phase 2 clinical trial evaluating
ZYNLONTA® (loncastuximab tesirine-lpyl) in combination with
rituximab demonstrated a high response rate in patients with
relapsed or refractory (r/r) follicular lymphoma (FL). The data
from the single-institution study conducted at the Sylvester
Comprehensive Cancer Center at the University of Miami Miller
School of Medicine were reported during an oral presentation
yesterday at the 65th American Society of Hematology (ASH) Annual
Meeting and Exposition by the study’s lead investigator, Juan Pablo
Alderuccio, MD, associate professor of medicine and hematologist at
Sylvester.
“In this first-ever study evaluating the
combination of ZYNLONTA and rituximab in patients with relapsed or
refractory follicular lymphoma, the overall response rate was 96%
and complete response rate was 85%, with a significant number of
patients achieving an early response,” said Mohamed Zaki, MD, PhD,
Chief Medical Officer of ADC Therapeutics. “We believe the high
early response rates highlight the exciting potential of ZYNLONTA
to be used in combination with an established therapy to improve
the treatment paradigm for patients with high-risk follicular
lymphoma, including those with POD24, high disease burden and/or
advanced disease, whose disease progresses after first-line
therapy.”
The trial is designed to evaluate the
combination in patients with r/r FL treated with ≥1 line of
systemic therapy presenting GELF criteria or POD24 at enrollment.
The primary endpoint of the study is complete response (CR) by week
12 PET/CT based on Lugano 2014 criteria. As of the data cutoff date
of November 26, 2023, 33 patients were enrolled out of a targeted
39 patients.
Patients were a median age of 68 years (range 47
to 89) and median lines of prior therapy were 1 (range 1-6). R-CHOP
was the most common first-line therapy (n=18; 54.5%) followed by
bendamustine with rituximab (n=8; 24.2%) and single-agent rituximab
(n=6; 18.2%).
The initial results are based on an analysis of
27 patients evaluable for efficacy and 32 patients evaluable for
toxicity. Highlights of the data presented at ASH include:
- Best overall response rate of 96.3%
and CR rate of 85.2%
- After a median follow-up of 9.7
months, the median progression-free survival (PFS) was not reached,
and the 12-month PFS was 92.3%
- Majority of adverse events (AEs)
were grade 1. Grade 3 AEs included neutropenia (n=2; 6.2%), and one
case each (3.1%) of hyperglycemia, increased ALT, fatigue, dyspnea
and skin infection. Neutropenia was the only grade 4 AE (n=1;
3.1%).
“The relapsed or refractory follicular lymphoma
patients enrolled in this trial represent a high-risk population in
need of a safe and durable treatment option that improves
outcomes,” said Dr. Alderuccio. “We are very encouraged by the high
response rate produced by ZYNLONTA combined with rituximab in
patients with a high disease burden and look forward to expanding
the trial.”
Based on the initial results, the investigators
are planning a multicenter clinical trial aiming to expand the
current cohort and decrease the length of therapy to six cycles.
The trial is expected to be launched in the first quarter of
2024.
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 IIT data in r/r follicular lymphoma presented at the 65th
ASH Annual Meeting and future clinical trials and results in the
same patient population, 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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