ADCT ADC Therapeutics SA

24.95
-0.39  -2%
Previous Close 25.34
Open 25.35
52 Week Low 20.01
52 Week High 56.5899
Market Cap $1,952,836,500
Shares 78,270,000
Float 31,110,099
Enterprise Value $1,536,493,500
Volume 535,119
Av. Daily Volume 360,533
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Upcoming Catalysts

Drug Stage Catalyst Date
ZYNLONTA (Loncastuximab Tesirine) and RITUXAN (rituximab) - (LOTIS 5)
Diffuse Large B-Cell Lymphoma
Phase 3
Phase 3
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Drug Pipeline

Drug Stage Notes
Camidanlumab tesirine
Hodgkin lymphoma (HL)
Phase 2
Phase 2
Phase 2 interim data presented June 22, 2021. Overall response rate (ORR) was 66.3% (67/101 patients) with a complete response rate (CRR) of 27.7% and partial response rate (PRR) of 38.6%. Median duration of response has not been reached.
Camidanlumab Tesirine and KEYTRUDA (pembrolizumab)
Solid Tumors
Phase 1b
Phase 1b
Phase 1b monotherapy data released at ASCO June 4, 2021.
ZYNLONTA (loncastuximab tesirine) + IMBRUVICA (Ibrutinib) - (LOTIS-3)
Diffuse Large B-Cell or Mantle Cell Lymphoma
Phase 1/2
Phase 1/2
Phase 2 pivotal trial ongoing.
ADCT-601
Solid tumors
Phase 1b
Phase 1b
Phase 1b trial to be initiated 1H 2022.
ZYNLONTA (Loncastuximab Tesirine)
Follicular Lymphoma
Phase 2
Phase 2
Phase 2 pivotal trial to be initiated 2Q 2021.
ZYNLONTA (Loncastuximab Tesirine)
Diffuse Large B-Cell Lymphoma
Approved
Approved
FDA approval announced April 23, 2021.

Latest News

  1. Phase 2 dosing schedule results in encouraging overall response rate and long-lasting treatment effects in heavily pre-treated patients with relapsed or refractory Hodgkin lymphoma

    Phase 2 safety profile, including incidence of GBS, consistent with Phase 1

    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 updated interim results from the ongoing pivotal Phase 2 clinical trial of camidanlumab tesirine (Cami) in patients with relapsed or refractory Hodgkin lymphoma were presented in an oral presentation (Abstract 075) at the 16th Annual International Conference on Malignant Lymphoma…

    Phase 2 dosing schedule results in encouraging overall response rate and long-lasting treatment effects in heavily pre-treated patients with relapsed or refractory Hodgkin lymphoma

    Phase 2 safety profile, including incidence of GBS, consistent with Phase 1

    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 updated interim results from the ongoing pivotal Phase 2 clinical trial of camidanlumab tesirine (Cami) in patients with relapsed or refractory Hodgkin lymphoma were presented in an oral presentation (Abstract 075) at the 16th Annual International Conference on Malignant Lymphoma (ICML). The pivotal Phase 2 study is intended to support the submission of a Biologics License Application.

    "The interim results from our ongoing pivotal Phase 2 trial of Cami as a single agent for patients with relapsed or refractory Hodgkin lymphoma demonstrate that a significant number of patients experience long-lasting treatment effects," said Jay Feingold, MD, PhD, Senior Vice President and Chief Medical Officer of ADC Therapeutics. "In Phase 2, we used the optimal Phase 1 dosing schedule based on activity and tolerability, and we are encouraged by the interim data that show the median duration of response has not been reached. We also note that the incidence of GBS in Phase 2 is consistent with Phase 1. We look forward to providing future updates on this pivotal program as the overall response rate and duration of response data continue to mature."

    Cami is being evaluated in a multicenter, open-label, single-arm Phase 2 clinical trial in 117 patients with relapsed or refractory Hodgkin lymphoma who have received ≥3 prior lines of treatment (≥2 lines if ineligible for hematopoietic stem cell transplantation, HSCT), including prior treatment with brentuximab vedotin and a checkpoint inhibitor. The interim data cut includes 101 evaluable patients who had been in the study a median of 5.1 months. Patients were heavily pretreated with a median of 6 prior lines of systemic therapy.

    Key data presented at ICML by 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, include:

    • Overall response rate (ORR) was 66.3% (67/101 patients) with a complete response rate (CRR) of 27.7% and partial response rate (PRR) of 38.6%
    • Median duration of response has not been reached
    • No new safety signals have been identified and the most common grade ≥3 treatment-emergent adverse events in ≥5% of patients were hypophosphatemia (7.7%), maculopapular rash (6.8%), thrombocytopenia (6.8%), anemia (6.0%) and lymphopenia (6.0%)
    • To date, nine patients (7.7%) were able to proceed to HSCT following Cami treatment
    • 7/117 patients (6.0%) developed Guillain-Barre syndrome/Polyradiculopathy (consistent with the incidence in the Phase 1 Hodgkin lymphoma patients)

    "Patients with relapsed or refractory Hodgkin lymphoma who have failed several lines of previous therapy such as brentuximab vedotin and PD-1 blockade have limited treatment options," said Dr. Zinzani. "The antitumor activity and safety profile of Cami continues to demonstrate that this novel CD25-targeted ADC has the potential to address the unmet need in heavily pre-treated patients."

    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.

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  2. LOTIS-2 updated results demonstrate durable responses of ZYNLONTA with median duration of response of 13.4 months in heavily pre-treated patients with relapsed or refractory DLBCL

    LOTIS-3 updated Phase 1 data highlight potential of ZYNLONTA™ in combination with ibrutinib in relapsed or refractory DLBCL and MCL patients

    LOTIS-5 and LOTIS-6 trials evaluating ZYNLONTA in combination with rituximab in DLBCL patients and as a single agent in FL patients also presented

    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 posters on four ZYNLONTA™ (loncastuximab tesirine-lpyl) clinical…

    LOTIS-2 updated results demonstrate durable responses of ZYNLONTA with median duration of response of 13.4 months in heavily pre-treated patients with relapsed or refractory DLBCL

    LOTIS-3 updated Phase 1 data highlight potential of ZYNLONTA™ in combination with ibrutinib in relapsed or refractory DLBCL and MCL patients

    LOTIS-5 and LOTIS-6 trials evaluating ZYNLONTA in combination with rituximab in DLBCL patients and as a single agent in FL patients also presented

    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 posters on four ZYNLONTA™ (loncastuximab tesirine-lpyl) clinical trials were presented at the 16th Annual International Conference on Malignant Lymphoma (ICML).

    "The updated results from our pivotal LOTIS-2 clinical trial presented at ICML continue to reinforce the efficacy across difficult-to-treat subgroups and sustained duration of response of commercially-available ZYNLONTA as a single agent for patients with relapsed or refractory diffuse large B-cell lymphoma," said Jay Feingold, MD, PhD, Senior Vice President and Chief Medical Officer of ADC Therapeutics. "We're also pleased that the updated data from the LOTIS-3 clinical trial demonstrate the encouraging antitumor activity and manageable toxicity profile of ZYNLONTA in combination with ibrutinib in patients with relapsed or refractory DLBCL or mantle cell lymphoma. We look forward to continued progress in all of our LOTIS trials, including the ongoing LOTIS-5 trial of ZYNLONTA in combination with rituximab and LOTIS-6 trial in patients with relapsed or refractory follicular lymphoma."

    LOTIS-2 Follow-up Analysis (Poster 177)

    In LOTIS-2, a single-arm, open-label, 145-patient Phase 2 clinical trial in patients with relapsed or refractory DLBCL who had failed ≥2 established therapies, ZYNLONTA demonstrated continued substantial antitumor activity and an acceptable safety profile. Updated results were presented in a poster by 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. As of the data cut-off date of March 1, 2021, all patients had completed treatment.

    Key data include:

    • Overall response rate (ORR) was 48.3% and complete response rate (CRR) was 24.8%
    • Median duration of response (mDoR) of 13.4 months for the 70 responders
    • Median duration of response not reached for patients with a complete response
    • Median overall survival was 9.5 months
    • No new safety concerns were identified during the study and no increase in toxicity was observed in patients aged ≥65 years compared with patients <65 years. The most common grade ≥3 treatment-emergent adverse events (TEAEs) were neutropenia (26.2%), thrombocytopenia (17.9%), increased gamma-glutamyltransferase (17.2%), and anemia (10.3%)

    LOTIS-3 Updated Phase 1 Results (Poster 238)

    LOTIS-3, a Phase 1/2, two-part, open-label, single-arm clinical trial, is evaluating ZYNLONTA in combination with ibrutinib in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) or mantle cell lymphoma (MCL). Updated Phase 1 results were presented in a poster by Julien Depaus, MD, Department of Hematology, CHU UCL Namur site Godinne, Yvoir, Belgium. As of the data cut-off date of March 1, 2021, 30 patients with DLBCL (24 with non-germinal center B-cell (non-GCB) DLBCL and 6 with GCB DLBCL) and 7 patients with MCL were included in the study.

    Key data include:

    • ORR in all patients was 62.2% and CRR was 35.1%
      • In non-GCB DLBCL patients, ORR was 66.7%
      • In GCB DLBCL patients, ORR was 16.7%
      • In MCL patients, ORR was 85.7%
    • ZYNLONTA in combination with ibrutinib had manageable toxicity, with the most common grade ≥3 TEAEs in ≥5% of patients being anemia (10.8%), neutropenia (10.8%), thrombocytopenia (5.4%), and fatigue (5.4%)
    • Pharmacokinetic profiles demonstrated sustained exposure and modest accumulation by Cycle 2

    Two additional posters presented at the 16th Annual ICML

    • Phase 3 Randomized Study of Loncastuximab Tesirine plus Rituximab versus Immunochemotherapy in Patients with Relapsed/Refractory Diffuse Large B-cell Lymphoma - LOTIS-5 (Poster 251)
    • 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 (Poster 264)

    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 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.

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  3. - Shareholders elect industry-leading financial executive Viviane Monges to Board of Directors

    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, today announced that shareholders approved all of the resolutions as proposed by the Board of Directors at yesterday's Annual General Meeting (AGM).

    Election of new Board member Viviane Monges

    Shareholders approved the election of Viviane Monges to the board of directors. Ms. Monges has 30 years of executive-level financial leadership experience with global corporations, predominantly in the pharmaceutical industry. She is a veteran Chief Financial Officer…

    - Shareholders elect industry-leading financial executive Viviane Monges to Board of Directors

    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, today announced that shareholders approved all of the resolutions as proposed by the Board of Directors at yesterday's Annual General Meeting (AGM).

    Election of new Board member Viviane Monges

    Shareholders approved the election of Viviane Monges to the board of directors. Ms. Monges has 30 years of executive-level financial leadership experience with global corporations, predominantly in the pharmaceutical industry. She is a veteran Chief Financial Officer (CFO) who has worked cross-functionally at both large and small companies deploying innovative strategies and building out finance teams.

    Ms. Monges was CFO of the Business Excellence Division at Nestlé. Prior to that, she spent nearly two decades leading financial operations for divisions of three pharmaceutical companies. She served as Group CFO at Galderma S.A., a multinational dermatology company. Ms. Monges served at Novartis A/G as EMEA CFO and then as Global CFO of the OTC Division. At Wyeth Pharmaceuticals/Pfizer she served as CFO of the Europe Region unit and as CFO of the Global Pharma Business unit.

    Ms. Monges provides financial and leadership counsel to companies as a board member of several innovative healthcare corporations, including DBV Technologies and Voluntis in France, UCB in Belgium, and Novo Holdings A/S in Denmark. Until May 2021, Ms. Monges also served on the board of Idorsia Pharmaceuticals.

    Re-election of the Board and Compensation Committee

    • Shareholders approved the re-election of Chairman of the Board Ron Squarer and all members of the Board who stood for re-election, for a term of one year.
    • Shareholders approved the proposed compensation of the Board of Directors and the Executive Committee, for a term of one year.
    • Shareholders approved an amendment to the Company's Articles of Association to increase the maximum size of the Board of Directors to 12 members.
    • Shareholders approved the re-election of all members of the Compensation Committee, each for a term of one year.

    Other proposals

    • All financial and capital proposals were approved including the increase and renewal of the Company's Authorized Share Capital by CHF 1,170,800.
    • Shareholders approved the re-election of the independent proxy and statutory auditor, each for a term of one year.

    For a complete overview of the results of the Company's AGM please refer to the Form 6-K filing at https://ir.adctherapeutics.com/sec-filings.

    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.

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

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

    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…

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

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

    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.

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  5. ZYNLONTA™ LOTIS-2 updated data includes median duration of response of 13.4 months in heavily pre-treated patients with relapsed or refractory DLBCL

    Subgroup analyses include patients with double- / triple-hit, advanced stage or transformed DLBCL, DLBCL refractory to first-line therapy, and patients older than 65

    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, today announced updated clinical data from the ZYNLONTA™ (loncastuximab tesirine-lpyl) Phase 2 LOTIS-2 trial in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) were presented at the 2021 American Society of Clinical…

    ZYNLONTA™ LOTIS-2 updated data includes median duration of response of 13.4 months in heavily pre-treated patients with relapsed or refractory DLBCL

    Subgroup analyses include patients with double- / triple-hit, advanced stage or transformed DLBCL, DLBCL refractory to first-line therapy, and patients older than 65

    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, today announced updated clinical data from the ZYNLONTA™ (loncastuximab tesirine-lpyl) Phase 2 LOTIS-2 trial in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) were presented at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting, which is being held virtually June 4-8, 2021.

    "The maturing duration of response from the ZYNLONTA Phase 2 trial reported at ASCO reflects the strong data set that served as the basis of the accelerated FDA approval in April," said Jay Feingold, MD, PhD, Senior Vice President and Chief Medical Officer of ADC Therapeutics. "We are especially encouraged to see this positive trend continue to strengthen in a heavily pre-treated patient population, including patients with double- / triple-hit, advanced stage or transformed DLBCL, DLBCL refractory to first-line therapy, and patients older than 65."

    In LOTIS-2, a single-arm, open-label, 145-patient Phase 2 clinical trial in patients with relapsed or refractory DLBCL who had failed ≥2 established therapies, ZYNLONTA demonstrated continued substantial antitumor activity and an acceptable safety profile. Updated results, including analysis of response in high-risk subgroups, were presented in a poster (abstract number: 7546) by Paolo F. Caimi, MD, University Hospitals Cleveland Medical Center and Case Comprehensive Cancer Center, Case Western Reserve University.

    Key data at the March 1, 2021 data cut include:

    • Overall response rate (ORR) was 48.3% and complete response rate (CRR) was 24.8%
    • Median duration of response (mDoR) of 13.4 months for the 70 responders
    • Median duration of response not reached for patients with a complete response
    • Durable responses in high-risk patient groups, including:
      • Patients with double- / triple-hit or transformed DLBCL each had a median DoR not reached
      • Patients with advanced stage disease (Stage III-IV) had a median DoR of 12.6 months
      • Median DoR for older patients was longer than for younger patients (≥75 years, not reached; ≥65 years to <75 years, 12.6 months; <65 years, 9.3 months)
      • Patients with DLBCL refractory to first-line systemic therapy had a median DoR of 9.6 months compared with 12.6 months for patients who relapsed after responding to initial therapy
    • No new safety concerns were identified during the study and no increase in toxicity was observed in patients aged ≥65 years compared with patients <65 years

    Two additional posters presented at the 2021 ASCO Annual Meeting:

    • Phase 3 randomized study of loncastuximab tesirine plus rituximab versus immunochemotherapy in patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL): LOTIS-5 (abstract number: TPS7574)
    • A Phase 1b, open-label, dose-escalation study to evaluate camidanlumab tesirine (Cami) as monotherapy in patients (pts) with advanced solid tumors (abstract number: 2556)

    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 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.

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