0000950103-21-008577.txt : 20210609 0000950103-21-008577.hdr.sgml : 20210609 20210609071907 ACCESSION NUMBER: 0000950103-21-008577 CONFORMED SUBMISSION TYPE: 6-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20210609 FILED AS OF DATE: 20210609 DATE AS OF CHANGE: 20210609 FILER: COMPANY DATA: COMPANY CONFORMED NAME: ADC Therapeutics SA CENTRAL INDEX KEY: 0001771910 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 000000000 STATE OF INCORPORATION: V8 FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 6-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-39071 FILM NUMBER: 211003971 BUSINESS ADDRESS: STREET 1: BIOPOLE STREET 2: ROUTE DE LA CORNICHE 3B CITY: EPALINGES STATE: V8 ZIP: 1066 BUSINESS PHONE: 41 21 653 02 00 MAIL ADDRESS: STREET 1: BIOPOLE STREET 2: ROUTE DE LA CORNICHE 3B CITY: EPALINGES STATE: V8 ZIP: 1066 6-K 1 dp152442_6k.htm FORM 6-K
 

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 June 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:

 

Form 20-F

  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):

 

 

 

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: June 9, 2021  
   
  By: /s/ Michael Forer
  Name: Michael Forer
  Title: Executive Vice President & General Counsel

 

 

 

EXHIBIT INDEX

 

Exhibit No. Description
99.1 Press release dated June 9, 2021

 

 

EX-99.1 2 dp152442_ex9901.htm EXHIBIT 99.1

Exhibit 99.1

 

 

 

 

 

ADC Therapeutics Announces Presentations at the 16th Annual International Conference on Malignant Lymphoma

 

Oral presentation of preliminary results from ongoing pivotal Phase 2 trial of camidanlumab tesirine in r/r Hodgkin lymphoma

 

LOTIS trials evaluating ZYNLONTATM as single agent and in combination with other therapies to also be highlighted

 

LAUSANNE, Switzerland, June 9, 2021 – ADC Therapeutics SA (NYSE:ADCT), a commercial-stage biotechnology company leading the development of novel antibody drug conjugates (ADCs) to treat hematological malignancies and solid tumors, announced today that abstracts on camidanlumab tesirine (Cami) and ZYNLONTA™ (loncastuximab tesirine-lpyl) have been selected for presentation at the 16th Annual International Conference on Malignant Lymphoma (ICML), which is being held virtually June 18-22, 2021.

 

“We are pleased that preliminary results from our ongoing pivotal Phase 2 trial of Cami as a single agent for patients with relapsed or refractory Hodgkin lymphoma have been selected for an oral presentation at ICML,” said Jay Feingold, MD, PhD, Senior Vice President and Chief Medical Officer of ADC Therapeutics. “We also look forward to sharing evolving data on ZYNLONTA (loncastuximab tesirine-lpyl) as a monotherapy and in combination for diffuse large B-cell lymphoma patients in need of new treatment options.”

 

Oral Presentation Details

 

Title: Camidanlumab Tesirine Efficacy and Safety in an Open-label, Multicenter, Phase 2 Study of Patients (pts) with Relapsed or Refractory Classical Hodgkin Lymphoma (R/R cHL)
Session: Hodgkin Lymphoma

Date/Time: June 22, 2021, 14:45-16:15 CEST
Presenter: Pier Luigi Zinzani, MD, PhD, IRCCS Azienda Ospedaliero-Universitaria di Bologna Istituto di Ematologia "Seràgnoli", and Dipartimento di Medicina Specialistica, Diagnostica e Sperimentale Università di Bologna, Bologna, Italy

Abstract Number: 075

 

Poster Presentation Details

 

Title: LOTIS 2 Follow-up Analysis: Updated Results from a Phase 2 Study of Loncastuximab Tesirine in Relapsed or Refractory Diffuse Large B-cell Lymphoma
Track: Aggressive NHL

Date/Time: June 18, 2021, 9:00 CEST
Presenter: Pier Luigi Zinzani, MD, PhD, IRCCS Azienda Ospedaliero-Universitaria di Bologna Istituto di Ematologia "Seràgnoli", and Dipartimento di Medicina Specialistica, Diagnostica e Sperimentale Università di Bologna, Bologna, Italy

Poster Number: 177

 

Title: A Phase 2 Randomized Study of Loncastuximab Tesirine (Lonca) Versus (Vs) Idelalisib in Patients (Pts) with Relapsed or Refractory (R/R) Follicular Lymphoma (FL) - LOTIS-6
Track: Ongoing Trials

 

 

 

Date/Time:  June 18, 2021, 9:00 CEST
Presenter: Carmelo Carlo-Stella, MD, Department of Oncology and Hematology, Humanitas Clinical and Research Center – IRCCS, and Humanitas University, Rozzano, Milano, Italy

Poster Number: 264

 

Title: Phase 3 Randomized Study of Loncastuximab Tesirine plus Rituximab versus Immunochemotherapy in Patients with Relapsed/Refractory Diffuse Large B-cell Lymphoma - LOTIS-5
Track: Ongoing Trials

Date/Time: June 18, 2021, 9:00 CEST
Presenter: Carmelo Carlo-Stella, MD, Department of Oncology and Hematology, Humanitas Clinical and Research Center – IRCCS, and Humanitas University, Rozzano, Milano, Italy

Poster Number: 251

 

Title: Clinical Activity of Loncastuximab Tesirine plus Ibrutinib in Non-Hodgkin Lymphoma: Updated LOTIS 3 Phase 1 Results
Track: New Drugs

Date/Time: June 18, 2021, 9:00 CEST
Presenter: Julien Depaus, MD, Department of Hematology, CHU UCL Namur site Godinne, Yvoir, Belgium

Poster Number: 238

 

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. 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.

 

The FDA approval was based on data from LOTIS-2, a large (n=145) Phase 2 multinational, single-arm clinical trial of ZYNLONTA for the treatment of adult patients with r/r 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 also enrolled patients who did not respond to first-line therapy, patients refractory to all prior lines of therapy, and patients who had stem cell transplants and CAR-T therapy prior to their treatment with ZYNLONTA. Results from the trial 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%).

 

 

 

ZYNLONTA is being evaluated in combination for earlier lines of therapy and as a monotherapy in other B-cell malignancies.

 

About Camidanlumab Tesirine (Cami)

 

Camidanlumab tesirine (Cami, formerly ADCT-301) 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 cancer patients 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 late-stage clinical trials 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, the Company has multiple PBD-based 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 trademark of ADC Therapeutics SA.

 

CONTACTS:

 

Investors

Eugenia Litz

ADC Therapeutics

Eugenia.Litz@adctherapeutics.com

+44 7879 627205

 

Amanda Hamilton

ADC Therapeutics

amanda.hamilton@adctherapeutics.com

+1 917-288-7023

 

 

 

EU Media

Alexandre Müller

Dynamics Group

amu@dynamicsgroup.ch

+41 (0) 43 268 3231

 

USA Media

Annie Starr

6 Degrees

astarr@6degreespr.com

+1 973-768-2170

 

 

 

 

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