Enrolment for the pivotal Phase II clinical trial (NCT04052997) evaluating the efficacy and safety of camidanlumab tesirine (formerly ADCT-301) in patients with relapsed or refractory Hodgkin lymphoma, has been completed. The trial enrolled a total of 117 patients.
Camidanlumab tesirine is an antibody-drug conjugate or ADC which includes a monoclonal antibody that binds to CD25 (HuMax®-TAC, licensed from Genmab), conjugated to the pyrrolobenzodiazepine (PBD) dimer payload, tesirine. Once bound to a CD25-expressing cell, camidanlumab tesirine is internalized into the cell where enzymes release the PBD-based warhead killing the cell. This applies to CD25-expressing tumor cells, and also to CD25-expressing Tregs.
The intra-tumoral release of its PBD warhead 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 Camidanlumab tesirine may enhance immune-mediated anti-tumor activity.
Camidanlumab tesirine is being evaluated in a pivotal Phase II clinical trial in patients with relapsed or refractory Hodgkin lymphoma, as well as in a Phase 1a/1b clinical trial in patients with relapsed or refractory Hodgkin lymphoma and non-Hodgkin lymphoma and a Phase Ib clinical trial as monotherapy and in combination with pembrolizumab in solid tumors.
During the 62nd American Society of Hematology (ASH) Annual Meeting, preliminary Phase II data was presented consistent with Phase I results. Based on 47 evaluable patients as of August 24, 2020, camidanlumab tesirine demonstrated an 83% overall response rate without new safety signals being identified.
“Completing enrollment in our pivotal trial of Cami brings us one step closer to potentially addressing an unmet need in heavily pre-treated Hodgkin lymphoma patients,” noted Jay Feingold, MD, Ph.D., Senior Vice President and Chief Medical Officer of ADC Therapeutics.
“We look forward to reporting updated interim data from the trial in the first half of this year.”
Study to Evaluate the Efficacy and Safety of Camidanlumab Tesirine (ADCT-301) in Patients With Relapsed or Refractory Hodgkin Lymphoma – NCT04052997
Featured image: Nurse talking to the wife of a patient diagnosed with Hodgkin lymphoma. Photo courtesy: © 2020 Fotolia/Adobe. used with permission