ADC Therapeutics Announces Results from Pivotal Phase 2 Clinical Trial of Camidanlumab Tesirine (Cami) in Relapsed or Refractory Hodgkin Lymphoma

Overall response rate of 70.1% and complete response rate of 33.3% in heavily pretreated patients; median duration of response of 13.7 months

Safety profile substantially consistent with prior findings

Preparing for potential submission of a Biologics License Application to the FDA

Cami data and diffuse large B-cell lymphoma posters to be presented today at the European Hematology Association 2022 Hybrid Congress

LAUSANNE, Switzerland--(BUSINESS WIRE)--ADC Therapeutics SA (NYSE: ADCT) announced today results from the ongoing pivotal Phase 2 clinical trial of camidanlumab tesirine (Cami) in relapsed or refractory (r/r) Hodgkin lymphoma. An overall response rate (ORR) of 70.1% and a complete response (CR) rate of 33.3% was observed with a median duration of response of 13.7 months for all responders in r/r Hodgkin lymphoma patients who were refractory or had relapsed after a median of 6 prior treatments, including brentuximab vedotin (BV) and a PD-1 blockade. The safety profile of Cami was substantially consistent with previously reported interim findings. The results will be presented today during an oral session at the European Hematology Association 2022 Hybrid Congress (EHA2022).

The Phase 2 single-arm, multicenter, open-label clinical trial is evaluating Cami in 117 patients with r/r Hodgkin lymphoma who have received ≥3 prior lines of treatment (≥2 lines if ineligible for hematopoietic stem cell transplantation, HSCT). Patients received a median of 6 prior lines of systemic therapy.

“Cami has demonstrated consistently favorable response rates and durability in Hodgkin lymphoma patients who have relapsed, despite using the best available treatments. These results offer hope to patients and doctors who need a new option,” said Joseph Camardo, MD, Chief Medical Officer of ADC Therapeutics. “With these data from our Phase 2 trial in hand, we look forward to scheduling a meeting with the FDA to discuss the potential submission of a Biologics License Application.”

Data to be presented at EHA2022 by Carmelo Carlo-Stella, MD, Department of Biomedical Sciences, Humanitas University, and Department of Oncology and Hematology, IRCCS Humanitas Research Hospital in Milan, Italy, include:

• ORR of 70.1% and CR rate of 33.3% in patients with a median of 6 prior treatments
• Median duration of response (DOR) was 13.7 months and median progression-free survival (PFS) was 9.1 months; patients who achieved a CR had a median DOR of 14.5 months
• 14 patients received HSCT following treatment with Cami
• The most common grade ≥3 treatment-emergent adverse events in ≥5% of patients were: thrombocytopenia (9.4%), anemia (8.5%), hypophosphatemia (7.7%), neutropenia (7.7%), maculopapular rash (6.8%) and lymphopenia (5.1%)
• 8/117 patients developed Guillain-Barré syndrome/polyradiculopathy. GBS symptoms could be mitigated with careful medical intervention.

“Very few viable or sustainable treatment options are available for patients with Hodgkin lymphoma who are refractory or relapse following treatment with brentuximab vedotin and PD-1 inhibitor therapy,” said Dr. Carlo-Stella. “Results from the pivotal Phase 2 trial indicate Cami, a novel CD25-targeted ADC, has the potential to fill the need for a new treatment option for heavily pretreated patients with Hodgkin lymphoma.”

In addition, the following three posters will be presented at EHA2022 today from 16:30 – 17:45 CEST / 10:30 a.m. – 11:45 a.m. EDT in Hall D:

• Health-Related Quality Of Life And Tolerability Of Loncastuximab Tesirine In High-Risk Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma Treated In A Phase 2 Clinical Trial (LOTIS 2)
  Abstract Code: P1717
  

• Real-World Characteristics And Clinical Outcomes In Relapse/Refractory Diffuse Large B-Cell Lymphoma Patients Who Received Car-T Therapy
  Abstract Code: P1182
  
  
• Real-World Characteristics And Clinical Outcomes In Relapse/Refractory Diffuse Large B-Cell Lymphoma Post Car-T Failure
  Abstract Code: P1181

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.

Forward-Looking Statements

This press release contains statements that constitute forward-looking statements. All statements other than statements of historical facts contained in this press release, including statements regarding our future results of operations and financial position, business and commercialization strategy, market opportunities, products and product candidates, research pipeline, ongoing and planned preclinical studies and clinical trials, regulatory submissions and approvals, projected revenues and expenses and the timing of revenues and expenses, timing and likelihood of success, as well as plans and objectives of management for future operations, are forward-looking statements. Forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to our management. Such statements are subject to risks and uncertainties, and actual results may differ materially from those expressed or implied in the forward-looking statements due to various factors, including those described in our filings with the U.S. Securities and Exchange Commission. No assurance can be given that such future results will be achieved. Such forward-looking statements contained in this document speak only as of the date of this press release. We expressly disclaim any obligation or undertaking to update these forward-looking statements contained in this press release to reflect any change in our expectations or any change in events, conditions, or circumstances on which such statements are based unless required to do so by applicable law. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements.

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