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)
Carlo-Stella, C. Ansell, S. Zinzani, P. L. Radford, John A Maddocks, K. Pinto, A. Collins, G. P. Bachanova, V. Bartlett, N. Bence-Bruckler, I.
Carlo-Stella, C.
Ansell, S.
Zinzani, P. L.
Radford, John A
Maddocks, K.
Pinto, A.
Collins, G. P.
Bachanova, V.
Bartlett, N.
Bence-Bruckler, I.
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Abstract
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 effi cacy 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
µg/kg on Day 1 of each 3-week cycle (2 cycles), then 30 µg/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–Barré 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 fi ndings, including similar incidence rates of
GBS/polyradiculopathy.
Authors
Carlo-Stella, C.
Ansell, S.
Zinzani, P. L.
Radford, John A
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. O.
Feldman, T.
Hess, B.
Bastos-Oreiro, M.
Iyengar, S.
Eisen, S.
Negievich, Y.
Wang, L.
Wuerthner, J.
Herrera, A. F.
Ansell, S.
Zinzani, P. L.
Radford, John A
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. O.
Feldman, T.
Hess, B.
Bastos-Oreiro, M.
Iyengar, S.
Eisen, S.
Negievich, Y.
Wang, L.
Wuerthner, J.
Herrera, A. F.
Description
Date
2022
Publisher
Collections
Keywords
Type
Meetings and Proceedings
Citation
Carlo-Stella C, Ansell S, Zinzani PL, Radford J, Maddocks K, Pinto A, et al. 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). Clin Lymphoma Myeloma Leuk. 2022 Oct;22 Suppl 2:S347. PubMed PMID: 36164029. Epub 2022/09/28. eng.