An overall response rate (ORR) of 70.1% was seen with camidanlumab tesirine in treatment of relapsed/refractory classical Hodgkin lymphoma (R/R cHL), according to recent findings of a phase 2 study. Results were reported at the Annual Meeting of the Society of Hematologic Oncology (SOHO) by Carmelo Carlo-Stella, MD, of Humanitas University and IRCCS Humanitas Research Hospital in Milano, Italy, and colleagues.1
Camidanlumab tesirine is an anti-CD25 monoclonal antibody–drug conjugate containing a pyrrolobenzodiazepine (PBD) dimer. In their presentation, Dr Carlo-Stella and colleagues reported on efficacy and safety results with camidanlumab tesirine monotherapy in treatment of R/R cHL.
The single-arm, open-label, multicenter study (ClinicalTrials.gov Identifier: NCT04052997) enrolled patients with R/R cHL who had received at least 3 prior systemic therapies, including brentuximab vedotin and anti-programmed cell death protein-1 (PD-1)-based therapy.
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Patients in this study were given camidanlumab tesirine intravenously, dosed at 45 mg/kg on day 1 of every 3-week cycle for 2 cycles. Patients then received the agent dosed at 30 mg/kg from cycle 3 and onwards for a maximum of 1 year. The primary endpoint was the ORR, and secondary endpoints involved duration of response (DOR), progression-free survival (PFS), and safety.
The trial included 117 patients. The median age was 37 years (range, 19-87). The Eastern Cooperative Oncology Group performance status was 0 in 54.7% of patients, and 1 in 40.2% of patients. The median number of prior systemic therapies was 6 (range, 3-19), and the majority of patients had undergone prior autologous or allogeneic hematopoietic stem cell transplantation (SCT).
The ORR in this study was 70.1% (95% CI, 60.9%-78.2%) with a data cutoff of November 1, 2021. The complete response (CR) rate was 33.3%, and it was higher in patients who had had prior SCT than in those without prior SCT. At a median follow-up of 10.7 months (range, 1.2-25.2+), the median DOR was 13.73 months (95% CI, 7.36-14.65).
As assessed by an independent reviewer, the median PFS for the all-treated population was 9.10 months (95% CI, 5.13-15.01). The median PFS among patients with a CR or partial response was 15.01 months (95% CI, 9.10-15.87).
Treatment-emergent adverse events (TEAEs) were reported in 99.1% of patients, including fatigue in 38.5% and maculopapular rash in 32.5%. Serious TEAEs were reported in 39.3% of patients, and there were fatal TEAEs in 3.4% of patients.
Immune-related TEAEs were reported in 32.5% of patients. TEAEs of grade 3 or higher considered related to the PBD dimer included skin/nail reactions in 20.5% and hepatobiliary test abnormalities in 6.8%. There were 8 patients who experienced Guillain-Barré syndrome/polyradiculopathy.
Dr Carlo-Stella and colleagues considered the safety profile in this study to be consistent with earlier findings. Camidanlumab tesirine showed a 70.1% ORR and 33.3% CR rate in a population that the researchers noted was heavily pretreated and who had prior failure with both brentuximab vedotin and PD-1 blockade.
Disclosures: The research was supported by ADC Therapeutics SA.The presenter declared affiliations with AbbVie, Adicet Bio, AstraZeneca, ADC Therapeutics, BMS, Caribou, Genentech/Roche, Genmab, Gilead, Karyopharm, KiTE Pharma, Merck, Pfizer, Regeneron, Seattle Genetics, Takeda, and Tubulis.
Reference
Carlo-Stella C, Ansell S, Zinzani PL, et al. Camidanlumab tesirine: updated efficacy and safety in an open-label, multicenter, phase 2 study of patients with relapsed or refractory classical Hodgkin lymphoma (R/R cHL). Presented at: Annual Meeting of the Society of Hematologic Oncology (SOHO); September 28-October 1, 2022. Abstract HL-339.
