ADC Therapeutics SA announced 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).
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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
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.