HL-339 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). Clinical lymphoma, myeloma & leukemia Carlo-Stella, C., Ansell, S., Zinzani, P. L., Radford, J., Maddocks, K., Pinto, A., Collins, G. P., Bachanova, V., Bartlett, N., Bence-Bruckler, I., Hamadani, M., Kline, J., Mayer, J., Savage, K. J., Advani, R., Calmi, P., Casasnovas, R., Feldman, T., Hess, B., Bastos-Oreiro, M., Iyengar, S., Eisen, S., Negievich, Y., Wang, L., Wuerthner, J., Herrera, A. F. 2022; 22 Suppl 2: S347


CONTEXT: Camidanlumab tesirine (Cami), an antibody-drug conjugate comprising a human IgG1 anti-CD25 monoclonal antibody conjugated to a pyrrolobenzodiazepine (PBD) dimer, displayed antitumor activity and manageable toxicity in a phase 1 trial in lymphoma, including R/R cHL (NCT02432235).OBJECTIVE: Present updated efficacy and safety data from a phase 2 study of Cami monotherapy in R/R cHL (NCT04052997).METHODS: Patients with R/R cHL and =3 prior systemic therapies including brentuximab vedotin and anti-PD-1 were enrolled.PRIMARY ENDPOINT: overall response rate (ORR). Patients received Cami 45 g/kg on Day 1 of each 3-week cycle (2 cycles), then 30 g/kg (subsequent cycles) for up to 1 year.RESULTS: Enrollment is complete (N=117). Median age was 37 years, 62% of patients were male, and 95% had an ECOG score of 0-1. Fourteen patients (12.0%) withdrew to undergo transplant (12 [10.3%] received transplant and were censored). In the all-treated population (N=117), ORR was 70.1% (82/117; 95% CI: 60.9-78.2); 33.3% (39/117) had complete response (CR). At median (range) follow-up of 10.7 (1.2-25.2+) months, the median (95% CI) duration of response (DOR) was 13.7 months (7.4-14.7) for all responders, 14.5 (7.4-not reached, NR) months and 7.9 (3.8-NR) months for patients with CR or PR. Median (95% CI) progression-free survival (PFS) was 9.1 (5.1-15.0) months. All-grade treatment-emergent AEs (TEAEs) in =25% of 117 patients were fatigue (38.5%), maculopapular rash (MR, 32.5%), pyrexia (29.9%), nausea (27.4%), and rash (26.5%). Grade =3 TEAEs in =5% of patients were thrombocytopenia (9.4%), anemia (8.5%), hypophosphatemia (7.7%), neutropenia (7.7%), MR (6.8%), and lymphopenia (5.1%). TEAEs considered immune-related (IR) occurred in 32.5% of patients; Grade =3 IR AEs (TEAEs and non-TEAEs; 8.5%). Guillain-Barre syndrome (GBS)/polyradiculopathy occurred in 8 patients (6.8%). At data cutoff, 4 cases had recovered (grade 2, n=2; grade 4, n=2); 4 had not recovered (grade 4, n=1; grade 3, n=3).CONCLUSIONS: Cami demonstrated an ORR of 70.1% (CR: 33.3%) with an encouraging median DOR of 13.7 months and median PFS of 9.1 months. Safety is consistent with prior findings, including similar incidence rates of GBS/polyradiculopathy. Abstract accepted/presented at the EHA 2022 Congress; Funding: ADC Therapeutics SA; medical writing: CiTRUS Health Group.

View details for DOI 10.1016/S2152-2650(22)01478-1

View details for PubMedID 36164029