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

Rhea-AI Summary

ADC Therapeutics announced encouraging results from its Phase 2 trial of camidanlumab tesirine (Cami) for relapsed/refractory Hodgkin lymphoma. The trial showed an overall response rate of 70.1% and a complete response rate of 33.3%. Patients experienced a median duration of response of 13.7 months, with a safety profile consistent with prior findings. The company is preparing to discuss a potential Biologics License Application submission with the FDA following these promising results presented at the European Hematology Association Hybrid Congress.

Positive

• Overall response rate of 70.1% and complete response rate of 33.3% in heavily pretreated patients.
• Median duration of response was 13.7 months, indicating strong efficacy.
• Consistent safety profile with previous findings, suggesting reliability.
• Potential for a Biologics License Application submission to the FDA.

Negative

• Relapsed/refractory Hodgkin lymphoma patients have limited treatment options, indicating high unmet need.
• Safety concerns noted with potential adverse events, including Guillain-Barré syndrome in 8 patients.

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.

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ADC Therapeutics

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ADC Therapeutics

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Source: ADC Therapeutics

FAQ

What were the results of the Phase 2 trial for ADCT's Cami?

The Phase 2 trial reported a 70.1% overall response rate and a 33.3% complete response rate in heavily pretreated Hodgkin lymphoma patients.

How long was the median duration of response for Cami in the trial?

The median duration of response was 13.7 months.

What safety profile was observed for Cami in the trial?

The safety profile was consistent with prior findings, but there were adverse events including Guillain-Barré syndrome.

Is ADC Therapeutics planning to submit a Biologics License Application for Cami?

Yes, ADC Therapeutics is preparing to discuss a potential Biologics License Application submission to the FDA.

Where were the results of the Phase 2 trial presented?

The results were presented at the European Hematology Association 2022 Hybrid Congress.