Results from the ongoing pivotal phase 2 clinical trial of Camidanlumab tesirine ( Cami ) in relapsed or refractory ( r/r ) Hodgkin lymphoma were presented at the European Hematology Association 2022 Hybrid Congress ( EHA2022 ).
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 and a PD-1 blockade.
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 safety profile of Cami was substantially consistent with previously reported interim findings.
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 or more of treatment ( 2 lines or more if ineligible for hematopoietic stem cell transplantation, HSCT ).
Patients received a median of 6 prior lines of systemic therapy.
The most common grade 3 treatment-emergent adverse events or more in greater than or equal to 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.
Camidanlumab tesirine is an antibody drug conjugate comprised of a monoclonal antibody that binds to CD25, 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. ( Xagena )
Source: ADC Therapeutics, 2022