Initial safety run‐in results from LOTIS-5
Phase 3 trial demonstrate ORR of 75% and 40% CR rate with no new
safety signals
Cami pivotal Phase 2 data to be highlighted in
encore oral and poster presentations
ADC Therapeutics SA (NYSE: ADCT) today announced that ZYNLONTA®
(loncastuximab tesirine-lpyl) and camidanlumab tesirine (Cami)
abstracts have been accepted for presentation at the Tenth Annual
Meeting of the Society of Hematologic Oncology (SOHO 2022), which
will be held in Houston, Texas from September 28–October 1,
2022.
“We are looking forward to sharing the encouraging initial
safety run-in results from our LOTIS-5 Phase 3 clinical trial
evaluating ZYNLONTA in combination with rituximab in patients with
relapsed or refractory diffuse large B-cell lymphoma at SOHO 2022,”
said Joseph Camardo, MD, Chief Medical Officer of ADC Therapeutics.
“This is one of several clinical studies of ZYNLONTA in combination
with other drugs intended to evaluate ZYNLONTA in earlier lines of
treatment. ”
LOTIS-5 Initial 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). Twenty patients were enrolled in
part 1 in a nonrandomized safety run‐in. In part 2, approximately
330 patients will be randomized 1:1 to receive Lonca‐R or
rituximab‐gemcitabine‐oxaliplatin (R‐GemOx).
The 20 patients in the safety run‐in were a median age of 74.5
years (range 35‐93) and received a median of 1 previous therapy
(range 1‐6). As of the February 28, 2022, data cutoff:
- The overall response rate by central review was 15/20 (75%). A
total of 8/20 (40%) and 7/20 (35%) patients attained complete
response and partial response, respectively.
- The most common all‐grade TEAEs, regardless of the relationship
to the study treatment, were rash (5 [25%]), fatigue (4 [20%]), and
increased gamma-glutamyl transferase (4 [20%]). The most common
grade ≥3 TEAEs were increased gamma-glutamyl transferase (3 [15%]),
increased alanine aminotransferase (2 [10%]), and neutropenia (2
[10%]).
These data will be presented in the following poster:
Initial Safety Run‐In Results of the Phase 3 LOTIS‐5 Trial:
Novel Combination of Loncastuximab Tesirine With Rituximab
(Lonca‐R) Versus Immunochemotherapy in Patients With R/R DLBCL
Poster Number: ABCL-320
Details of ADC Therapeutics’ other poster presentations:
A Phase 2, Open-Label Study of Loncastuximab Tesirine in
Combination with Rituximab (Lonca-R) in Previously Untreated
Unfit/Frail Patients with Diffuse Large B-cell Lymphoma (DLBCL)
(LOTIS-9) (Encore data, first time as presentation) Poster
Number: ABCL-272
Health-Related Quality of Life and Tolerability in Patients
With/Without Skin Toxicity During Loncastuximab Tesirine Treatment
in a Phase 2 Clinical Trial (LOTIS-2) Poster Number:
ABCL-316
Long-term survival projections of loncastuximab
tesirine-treated patients in relapsed or refractory (R/R) diffuse
large B-cell lymphoma (DLBCL) (Encore data, first time as
presentation) Poster Number: ABCL-334
Camidanlumab Tesirine: Updated Efficacy and Safety in an
Open-Label, Multicenter, Phase 2 Study of Patients with Relapsed or
Refractory Classical Hodgkin Lymphoma (R/R cHL) (Encore) Poster
Number: HL-339
All posters will be presented on Wednesday, September 28 from
5:05 to 6:30 p.m. CT in Ballroom of Americas on Level 2 of the
Hilton-Americas Houston. Posters will remain in the poster hall for
viewing throughout the day on Thursday and Friday. Online access to
posters for registered attendees will begin on Thursday, September
29.
Details of ADC Therapeutics’ oral presentation:
Camidanlumab Tesirine: Updated Efficacy and Safety in an
Open-Label, Multicenter, Phase 2 Study of Patients with Relapsed or
Refractory Classical Hodgkin Lymphoma (R/R cHL) (Encore) Date
and Time: Friday, September 30, 5:48-5:58 p.m. CT Location: Grand
Ballroom G-L, 4th floor Presenter: Alex Herrera, MD, City of Hope,
Duarte, California, USA Session XII: Hodgkin Lymphoma
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) has 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 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.
ZYNLONTA is also being evaluated as a therapeutic option in
combination studies in other B-cell malignancies and earlier lines
of therapy.
About Camidanlumab Tesirine (Cami)
Camidanlumab tesirine (Cami) is an antibody drug conjugate (ADC)
comprised of a monoclonal antibody that binds to CD25 (HuMax®-TAC,
licensed from Genmab A/S), conjugated to the pyrrolobenzodiazepine
(PBD) dimer payload, tesirine. Once bound to a CD25-expressing
cell, Cami is internalized into the cell where enzymes release the
PBD-based payload, killing the cell. This applies to
CD25-expressing tumor cells and also to CD25-expressing Tregs. The
intra-tumoral release of its PBD payload may also cause bystander
killing of neighboring tumor cells, and PBDs have also been shown
to induce immunogenic cell death. All of these properties of Cami
may enhance immune-mediated anti-tumor activity.
Cami is being evaluated in a pivotal Phase 2 clinical trial in
patients with relapsed or refractory Hodgkin lymphoma and a Phase
1b clinical trial as monotherapy and in combination with
pembrolizumab in solid tumors.
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. Cami (camidanlumab tesirine) is being evaluated
in a pivotal Phase 2 trial for relapsed or refractory Hodgkin
lymphoma and in a Phase 1b clinical trial for various advanced
solid tumors. In addition to ZYNLONTA and Cami, 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20220921005889/en/
Investors Eugenia Litz ADC Therapeutics
Eugenia.Litz@adctherapeutics.com +44 7879 627205
Amanda Hamilton ADC Therapeutics
amanda.hamilton@adctherapeutics.com +1 917-288-7023
Media Mary Ann Ondish ADC Therapeutics
maryann.ondish@adctherapeutics.com +1 914-552-4625
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