On October 17, 2019 ADC Therapeutics SA, a clinical-stage oncology-focused biotechnology company pioneering the development of highly potent and targeted antibody drug conjugates (ADCs) for patients suffering from hematological malignancies and solid tumors, reported that the first patients have been dosed in a 100-patient pivotal Phase 2 clinical trial evaluating the efficacy and safety of ADCT-301 (camidanlumab tesirine) in patients with relapsed or refractory Hodgkin lymphoma (HL) (Press release, ADC Therapeutics, OCT 17, 2019, View Source [SID1234596054]). The trial is intended to support the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA).

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Alex Herrera, MD, Assistant Professor, Department of Hematology/Hematopoietic Cell Transplantation at City of Hope Medical Center and an investigator for the trial, said, "Approximately 15 to 25 percent of the 16,500 patients diagnosed with HL each year in the U.S. and Europe have relapsed or refractory HL. While advances have been made in the treatment of HL, a significant unmet medical need remains in the relapsed or refractory HL patient population, especially patients who have progressed following treatment with other novel agents. I believe ADCT-301 has the potential to fill this important medical need."

The primary objective of the Phase 2, multi-center, open-label, single-arm clinical trial is to evaluate the efficacy of ADCT-301 in patients with relapsed or refractory HL, measured by overall response rate based on the 2014 Lugano Classification Criteria. Patients with pathologically confirmed relapsed or refractory HL who have failed three prior lines of therapy, including brentuximab vedotin and a checkpoint inhibitor approved for HL such as nivolumab or pembrolizumab, are eligible for enrollment in the clinical trial.

Jay Feingold, MD, PhD, Senior Vice President, Chief Medical Officer and Head of Oncology Clinical Development at ADC Therapeutics, said, "In our large Phase 1 clinical trial, ADCT-301 demonstrated an overall response rate of 86.5 percent in patients with HL at the dose we are using in the pivotal Phase 2 clinical trial, with more than half of those being complete responses. We look forward to continuing the evaluation of ADCT-301 in this pivotal Phase 2 trial and, if successful, submitting a BLA to the FDA for accelerated approval of ADCT-301 for the treatment of relapsed or refractory HL in patients who have failed or were intolerant to brentuximab vedotin and a checkpoint inhibitor approved for HL."

For more information about the pivotal Phase 2 clinical trial of ADCT-301, please visit View Source (identifier NCT04052997).

About ADCT-301

ADCT-301 (camidanlumab tesirine) is an antibody drug conjugate (ADC) composed of a human 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 tumor cell, ADCT-301 is internalized into the cell where enzymes release the PBD-based warhead killing the cell with an immunogenic cell death. The intra-tumoral release of its PBD warhead may also cause bystander killing of neighboring tumor cells. The ADC also depletes CD25-positive regulatory T cells in the tumor environment. All of these properties of ADCT-301 may enhance immune-mediated anti-tumor activity. ADCT-301 is being evaluated in a pivotal Phase 2 clinical trial in patients with relapsed or refractory Hodgkin lymphoma (NCT04052997), as well as ongoing Phase 1a/1b clinical trials in patients with relapsed or refractory Hodgkin lymphoma and non-Hodgkin lymphoma (NCT02432235) and a Phase 1b clinical trial in solid tumors (NCT03621982).