ADC Therapeutics SA (NYSE: ADCT) today announced updated results
from LOTIS-2, the pivotal Phase 2 clinical trial of ZYNLONTA®
(loncastuximab tesirine-lpyl) in patients with relapsed/refractory
diffuse large B-cell lymphoma (DLBCL). The data are being presented
in a poster today at the European Hematology Association 2023
Hybrid Congress (EHA2023) and will also be featured in an oral
presentation at the 17th International Conference on Malignant
Lymphoma (17-ICML) being held in Lugano, Switzerland from June
13-17, 2023.
“We’re pleased to be sharing updated LOTIS-2
results demonstrating the long‐term efficacy and safety of ZYNLONTA
with the lymphoma community at EHA2023 and 17-ICML,” said Mohamed
Zaki, MD, PhD, Chief Medical Officer of ADC Therapeutics.
“Importantly, 31% of patients who achieved a complete response
remained event-free for two or more years and did not need new
anticancer therapy, which we believe validates the durability of
ZYNLONTA in heavily pretreated patients with diffuse large B-cell
lymphoma.”
The multicenter, open‐label, single‐arm Phase 2
LOTIS-2 study that evaluated ZYNLONTA in patients with relapsed or
refractory DLBCL after ≥2 prior systemic therapies resulted in an
overall response rate (ORR) of 48.3% (70/145), with a complete
response (CR) rate of 24.8% (36/145). The median (range) time to
response was 41.0 (35 to 247) days for all responders and 42.0 (36
to 247) days for patients with a CR.
All-grade treatment‐emergent adverse events occurring in ≥30%
of all patients were increased gamma-glutamyltransferase (42%),
neutropenia (40%), and thrombocytopenia (33%).
Key data from 145 evaluable patients as of the data cutoff of
September 15, 2022 include the following:
- The median duration of response (mDOR) was not reached for
patients with a CR and was 13.37 months among all responding
patients
- Of the 36 patients with a CR, 11 (31%) were event-free for ≥2
years with no evidence of disease and no new anticancer
therapy
- In the subsets of patients who were event-free for ≥1 year and
≥2 years, the median (range) duration of time patients remained
treatment-free post-ZYNLONTA was 24.8 (3.4 to 37.5) months and 27.7
(20.7 to 37.5) months, respectively
- No new safety signals were identified
“The updated results of the LOTIS-2 study
demonstrate significant clinical benefit for patients with
recurrent diffuse large B-cell lymphoma, an aggressive subtype of
non-Hodgkin lymphoma,” said Mehdi Hamadani, MD, Professor, Medical
College of Wisconsin. “I am excited by the potential of ZYNLONTA to
treat underserved patients. ZYNLONTA continues to be a welcome
option for patients with difficult-to-treat lymphoma and gives hope
to them and their families.”
Presentations at 17-ICML
Details of ADC Therapeutics’ oral presentation at 17-ICML are as
follows:
Long-Term Responses with Loncastuximab Tesirine: Updated Results
From LOTIS-2, the Pivotal Phase 2 Study In Patients with
Relapsed/Refractory Diffuse Large B-Cell Lymphoma [Encore of EHA
2023]Session: “Focus On...” Session - Large B-Cell And Double Hit
LymphomasSession Date and Time: Thursday, June 15, 2023, 17:00 –
18:00 CEST // 11:00 am – 12:00 pm EDTPresentation Time: 17:30 CEST
// 11:30 am EDTLocation: Cinema CorsoPresenting Author: Paolo F.
Caimi, MD, Cleveland Clinic Taussig Cancer Center, Cleveland, OH,
USA
Details of a poster presentation independently driven by IGM
Biosciences at 17-ICML are as follows:
Combination of Imvotamab and Loncastuximab Tesirine Shows
Enhanced Anti-Tumor Activity in a Preclinical Model of
Non-Hodgkin’s LymphomaSession: Lugano Poster sessionLocation:
Marquee Parco CianiPresenting Author: Kathryn A. Logronio, IGM
Biosciences, Inc.
Posters will be available on: Wednesday, June 14, 2023, 12:00 –
18:00 CEST; Thursday, June 15, 2023, 10:00 – 18:00 CEST; and
Friday, June 16, 2023, 10:00 – 18:00 CEST. Presenters will be with
posters on Thursday, June 15, 2023, from 12:30 – 13:00 CEST.
ePosters will be accessible virtually in Gallery from June
14-December 15, 2023.
Titles of ADC Therapeutics’ abstracts accepted for publication
only are as follows:
- LOTIS-5, an Ongoing Phase 3 Randomized Study of Loncastuximab
Tesirine with Rituximab (Lonca-R) Versus Immunochemotherapy in
Patients with R/R DLBCL
- Phase 1b Open-Label Study of Loncastuximab Tesirine in
Combination with Other Anticancer Agents in Patients with
Relapsed/Refractory B-cell Non-Hodgkin Lymphoma (LOTIS-7) [Encore
of ASCO 2023]
All accepted abstracts will be included in the Abstract Book,
supplement to “Hematological Oncology” (John Wiley and Sons, Inc.),
published online on Wiley Online Library on June 9 (23:59
CEST).
About ZYNLONTA® (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://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. 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 benefits, if any, of the updated clinical data from
the LOTIS-2 study of ZYNLONTA® to be presented at EHA2023 and
17-ICML; 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 and 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; our strategic partners’, including
Mitsubishi Tanabe Pharma Corporation and Overland Pharmaceuticals,
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, 7 and 9, ADCT 901, 601 and 602, 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; 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; the Company’s ability to obtain financial and other
resources for its research, development, clinical, and commercial
activities and other statements regarding matters that are not
historical facts, and involve predictions. 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. 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. 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.
InvestorsEugenia LitzADC
TherapeuticsEugenia.Litz@adctherapeutics.com+44 7879 627205
MediaMary Ann OndishADC
Therapeuticsmaryann.ondish@adctherapeutics.com+1 914-552-4625
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