ADC Therapeutics Announces Plan to Discontinue the Phase 2 LOTIS-9 Clinical Trial of ZYNLONTA® (loncastuximab tesirine-lpyl) and Rituximab in Unfit or Frail Previously Untreated DLBCL Patients
July 20 2023 - 4:05PM
ADC Therapeutics SA (NYSE: ADCT) today announced that it plans to
discontinue the Phase 2 LOTIS-9 clinical trial evaluating ZYNLONTA®
(loncastuximab tesirine-lpyl) and rituximab (Lonca-R) in unfit or
frail patients with previously untreated diffuse large B-cell
lymphoma (DLBCL). Given the challenges of defining the addressable
segment of the difficult-to-treat unfit or frail DLBCL patient
population, including many patients with significant active
underlying co-morbidities, the benefit-risk profile does not
support continuation of the LOTIS-9 trial.
Following a meeting yesterday, the U.S. Food and
Drug Administration (FDA) placed a partial clinical hold on the
trial for new patient enrollment but will allow patients already on
therapy who are deriving clinical benefit to remain on therapy
after being reconsented. Following treatment of any reconsenting
patients, the Company will conduct the necessary steps to conclude
the trial and does not plan to continue studying this regimen in
the unfit or frail previously untreated DLBCL patient
population.
About (loncastuximab tesirine-lpyl)
The U.S. Food and Drug Administration (FDA) and
the European Medicines Agency 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 DLBCL not otherwise specified, 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.
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://www.adctherapeutics.com/ and follow the company on Twitter
and 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, including
statements concerning the Company’s intentions regarding its
LOTIS-9 or other clinical trials and any actions taken by
regulatory authorities relating to the same. 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 nature, frequency and severity
of adverse events; the ability to complete clinical trials on
expected timelines, if at all; the outcome of clinical trials or
the sufficiency of results from such clinical trials; the timing
and results of the Company’s or its partners’ research projects or
clinical trials including LOTIS 5, 7 and 9, ADCT 901, 601 and 602;
and the timing and outcome of regulatory submissions and actions by
the FDA or other regulatory agencies with respect to the Company’s
products or product candidates. 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. 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
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