Report of Foreign Issuer Pursuant to Rule 13a-16 or 15d-16 (6-k)
October 29 2021 - 7:21AM
Edgar (US Regulatory)
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 October 2021.
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 Validation of its Marketing Authorization Application by the European Medicines Agency for ZYNLONTA®
Application
supported by data from pivotal LOTIS-2 trial in adult patients with relapsed or refractory diffuse large B-cell lymphoma
Milestone
achieved in commitment to make ZYNLONTA widely available to patients in need
Lausanne,
Switzerland, October 29, 2021 – ADC Therapeutics SA (NYSE: ADCT), a commercial-stage biotechnology company improving the lives
of those affected by cancer with its next-generation, targeted antibody drug conjugates (ADCs) for patients with hematologic malignancies
and solid tumors, today announced its Marketing Authorization Application (MAA) for ZYNLONTA®, a CD19-targeted ADC for the treatment
of relapsed or refractory diffuse large B-cell lymphoma (DLBCL), has been validated by the European Medicines Agency (EMA). Validation
of the application enables the evaluation process by the EMA’s Committee for Medicinal Products for Human Use (CHMP) to begin.
In
April 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to ZYNLONTA as the first and only CD19-targeted
ADC as a single-agent treatment for adult patients with relapsed or refractory DLBCL after two or more lines of systemic therapy. In
September 2021, the European Commission granted Orphan Drug Designation to ZYNLONTA for the treatment of DLBCL.
The
MAA is supported by data from LOTIS-2, a large (n=145) Phase 2 multinational, single-arm clinical trial of ZYNLONTA for the treatment
of adult patients with relapsed or refractory DLBCL following two or more prior lines of systemic therapy. The trial included a broad
spectrum of heavily pre-treated patients (median three prior lines of therapy) with very difficult to treat disease, including patients
with high-grade B-cell lymphoma. The trial enrolled 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 transplants and CAR-T therapy prior to their
treatment with ZYNLONTA.
Results
from LOTIS-2 demonstrated an overall response rate (ORR) of 48.3% (70/145 patients), which included a complete response (CR) rate of
24.1% (35/145 patients) and a partial response (PR) rate of 24.1% (35/145 patients). Patients had a median time to response of 1.3 months.
At the most recent data cut-off for patients enrolled in the trial, the median duration of response (mDoR) was 13.4 months. In a pooled
safety population the most common adverse reactions (≥20%) were thrombocytopenia, gamma-glutamyltransferase increased, neutropenia,
anemia, hyperglycemia, transaminase elevation, fatigue, hypoalbuminemia, rash, edema, nausea and musculoskeletal pain. In LOTIS-2, the
most common (≥10%) grade ≥3 treatment-emergent adverse events were neutropenia (26.2%), thrombocytopenia (17.9%), gamma-glutamyltransferase
increased (17.2%) and anemia (10.3%).
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 diffuse large B-cell lymphoma (DLBCL) not
otherwise specified (NOS), 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 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 late-stage clinical 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. 333-256686 and 333-256807) 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.
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ADC Therapeutics SA
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Date: October 29, 2021
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By:
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/s/ Michael Forer
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Name:
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Michael Forer
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Title:
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Executive Vice President and General Counsel
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