ADC Therapeutics SA (NYSE: ADCT) today announced the completion of
dose escalation in LOTIS-7, a Phase 1b open-label clinical trial
evaluating ZYNLONTA® (loncastuximab tesirine-lpyl) in combination
with bispecific antibodies glofitamab or mosunetuzumab in heavily
pre-treated patients with relapsed/refractory B-cell non-Hodgkin
lymphoma (r/r B-NHL).
In the dose escalation portion (Part 1) of LOTIS-7, no
dose-limiting toxicities (DLTs), no or low-grade cytokine release
syndrome (CRS) and no immune effector cell-associated neurotoxicity
syndrome (ICANS) were observed across all patients when ZYNLONTA
was administered in combination with glofitamab or mosunetuzumab.
Additionally, after the first investigator assessment, evidence of
anti-tumor activity was observed among the majority of patients,
with mixed histologies including diffuse large B-cell lymphoma
(DLBCL), follicular lymphoma (FL) and marginal zone lymphoma (MZL).
Based on the data from Part 1, all three dose levels (90, 120 and
150 µg/kg) have now been cleared and enrollment in Part 2 dose
expansion has been initiated with ZYNLONTA administered in
combination with glofitamab at the 120 µg/kg and 150 µg/kg dose
levels in 2L+ DLBCL.
“The early data from Part 1 of our LOTIS-7 trial highlight the
potential combinability of ZYNLONTA with bispecifics in lymphoma
patients,” said Mohamed Zaki, MD, PhD, Chief Medical Officer of ADC
Therapeutics. “We look forward to the continued progression of this
trial in 2L+ DLBCL patients.”
“CRS is a common toxicity associated with the CAR-T and
bispecific therapies currently used to treat lymphoma,” said Juan
Pablo Alderuccio, MD, lead investigator of the LOTIS-7 trial and
Associate Professor in the Division of Hematology at the
Sylvester Comprehensive Cancer Center at the University
of Miami Miller School of Medicine. “The potential for ZYNLONTA in
combination with bispecifics to treat 2L+ relapsed or refractory
B-NHL with the favorable toxicity profile observed thus far is
encouraging given the unmet medical need in this area.”
“With no or low grades of CRS and no ICANS observed among
patients in Part 1 of the study, we believe LOTIS-7 demonstrates
the potential for ZYNLONTA plus bispecifics to enable broader
accessibility in community settings,” said Ameet Mallik, Chief
Executive Officer of ADC Therapeutics. “Based upon the current data
and coupled with the potential for additive or even synergistic
efficacy with this combination, we continue to be excited about the
opportunity to expand the use of ZYNLONTA in DLBCL in the future
where there remains high unmet need.”
LOTIS-7 is a Phase 1b global multicenter, multi-arm study in
patients with relapsed or refractory B-cell non-Hodgkin lymphoma
including Part 1 (dose escalation) and Part 2 (dose expansion). The
three dosing arms include ZYNLONTA plus polatuzumab vedotin,
ZYNLONTA plus glofitamab, and ZYNLONTA plus mosunetuzumab
T-cell-engaging bispecific monoclonal antibodies (BsAbs).
Enrollment in LOTIS-7 includes Part 1 of the study with a 3+3 dose
escalation in 3L/3L+ heavily pre-treated patients with ZYNLONTA
doses starting at 90 µg/kg and then proceeding to 120 µg/kg and 150
µg/kg. The dose-limiting toxicity period has now been cleared
across all three dose levels.
For more information about the LOTIS-7 trial, visit
clinicaltrials.gov (NCT04970901).
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 high-grade B-cell lymphoma. The LOTIS-2 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: the timing
and results of the LOTIS-7 study including Part 2, does expansion,
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 (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 future
results from the University of Miami’s IITs in FL and MZL
lymphomas; 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
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