ADC Therapeutics SA (NYSE: ADCT) today announced results from its ongoing pivotal Phase II clinical trial of camidanlumab tesirine (Cami) in patients with relapsed or refractory (R/R) Hodgkin’s lymphoma. An overall response rate (ORR) of 70.1% and an overall response rate (CR) of 33.3% with a median duration of response of 13.7 months was observed in all responders with RR Hodgkin lymphoma who followed an average six prior treatments were refractory or relapsed, including brentuximab vedotin (BV) and PD-1 blockade. The safety profile of Cami was essentially consistent when compared to previous interim results. The results will be presented today at the European Hematology Association 2022 Hybrid Congress (EHA2022) during an oral session.
The Phase II, single-arm, open-label, multicenter clinical trial is evaluating Cami in 117 relapsed/refractory patients with Hodgkin’s lymphoma who received =3 prior lines of treatment (=2 lines if unfit for hematopoietic stem cell transplantation, HSCT). Patients had previously received a median of six lines of systemic treatment.
“Cami has demonstrated its consistently positive response rates and durability of response in Hodgkin lymphoma patients who have relapsed despite using the best available treatments. These results are promising for all patients and physicians awaiting a new treatment option,” said Joseph Camardo, MD, chief medical officer of ADC Therapeutics. “With the data now available from our Phase II study, we are pleased to schedule a meeting with the FDA to discuss the potential filing of a Biologics License Application.”
Data to be presented at the EHA2022 Congress 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:
- Overall response rate of 70.1% and overall response rate of 33.3% in patients with a median of six 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 treatment-emergent adverse events in =5% patients with grade =3 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 can be alleviated with careful medical intervention.
“Very few viable or sustainable treatment options are available for patients with refractory/relapsed Hodgkin’s lymphoma following treatment with brentuximab vedotin and PD-1 inhibitor therapy,” said Dr. Carlo Stella. “Results from the pivotal Phase II study signal that Cami, a novel CD25-targeted antibody-drug conjugate (AWC), has the potential to address an unmet need for a new treatment option for heavily pretreated patients with Hodgkin’s disease. to meet lymphoma.”
Additionally, the following three posters will be presented today at 4:30pm – 5:45pm CEST / 10:30am – 11:45am 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) [Gesundheitsbezogene Lebensqualität und Verträglichkeit von Loncastuximab-Tesirin bei Hochrisikopatienten mit rezidiviertem/refraktärem diffus-großzelligem B-Zell-Lymphom, das im Verlauf einer klinischen Phase-II-Studie (LOTIS 2) behandelt wurde]
Abstract Code: P1717
- Real-World Characteristics And Clinical Outcomes In Relapse/Refractory Diffuse Large B-Cell Lymphoma Patients Who Received Car-T Therapy received 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) composed of a monoclonal antibody that binds to CD25 (HuMax®-TAC, licensed from Genmab A/S) and conjugated to the pyrrolobenzodiazepine (PBD) dimer -Payload tesirine is conjugated. Once bound to a CD25-expressing tumor cell, Cami is internalized into the cell where enzymes release the PBD-based cytotoxic payload and kill the cell. This applies both to CD25-expressing tumor cells and to CD25-expressing regulatory T cells (Treg). The intratumoral release of the PBD payload can also lead to “bystander killing” of neighboring tumor cells. In addition, PBDs have been shown to induce immunogenic cell death. All of these properties of Cami can enhance immune-mediated antitumor activity.
Cami is being evaluated in a pivotal Phase 2 clinical trial in patients with relapsed or refractory Hodgkin lymphoma (HL) and in 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 biotechnology company improving the quality of life for cancer patients with its next-generation targeted antibody-drug conjugates (ADCs). The Company is advancing the development of its proprietary PBD-based ADC technology to transform the treatment paradigm for patients with hematologic malignancies and solid tumors.
ADC Therapeutics’ CD19-targeted AWK ZYNLONTA (Loncastuximab-Tesirin-Lpyl) is FDA-approved 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 as a combination therapy with other agents. Cami (camidanlumab tesirine) is being evaluated in a pivotal Phase 2 clinical trial in relapsed or refractory Hodgkin lymphoma and in a Phase 1b clinical trial in various advanced solid tumors. In addition to ZYNLONTA and Cami, ADC Therapeutics has several ADCs in ongoing clinical and pre-clinical development.
Headquartered in Lausanne (Biopôle), Switzerland, ADC Therapeutics has operations in London, the San Francisco Bay Area and New Jersey. Visit https://adctherapeutics.com/ for more information. Follow the company on Twitter and LinkedIn.
ZYNLONTA® is a registered trademark of ADC Therapeutics SA.
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