UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN
PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the month of September 2022.
Commission File Number: 001-39071
ADC Therapeutics SA
(Exact name of registrant as specified in its
charter)
Biopôle
Route de la Corniche
3B
1066 Epalinges
Switzerland
(Address of principal executive office)
Indicate by check
mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F:
Indicate by check mark if the registrant
is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ☐
Indicate by check mark if the registrant
is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ☐
ADC Therapeutics Announces Abstracts to be Presented
at the Tenth Annual Meeting of the Society of Hematologic Oncology (SOHO 2022)
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
Lausanne, Switzerland,
September 21, 2022 – 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.
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-glutamyltransferase (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 29th.
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.
ZYNLONTA® is
a registered trademark of ADC Therapeutics SA.
INCORPORATION
BY REFERENCE
This Report on Form
6-K shall be deemed to be incorporated by reference into the registration statements on Form F-3 (Registration Nos. 333-267293 and 333-267295)
of ADC Therapeutics SA and to be a part thereof from the date on which this report is filed, to the extent not superseded by documents
or reports subsequently filed or furnished.
SIGNATURE
Pursuant to the
requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned,
thereunto duly authorized.
|
ADC Therapeutics SA |
Date: September 21, 2022 |
|
|
|
|
By: |
/s/ Michael Forer |
|
Name: |
Michael Forer |
|
Title: |
Executive Vice President and General Counsel |
ADC Therapeutics (NYSE:ADCT)
Historical Stock Chart
From Feb 2024 to Mar 2024
ADC Therapeutics (NYSE:ADCT)
Historical Stock Chart
From Mar 2023 to Mar 2024