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)

Carmelo Carlo-Stella, Stephen Ansell, Pier Luigi Zinzani, John Radford, Kami Maddocks, Antonio Pinto, Graham P. Collins, Veronika Bachanova, Nancy Bartlett, Isabelle Bence-Bruckler, Mehdi Hamadani, Justin Kline, Jiri Mayer, Kerry J. Savage, Ranjana Advani, Paolo Calmi, René Olivier Casasnovas, Tatyana Feldman, Brian Hess, Mariana Bastos-OreiroSunil Iyengar, Sandy Eisen, Yanina Negievich, Luqiang Wang, Jens Wuerthner, Alex F. Herrera

Research output: Chapter in Book/Report/Conference proceedingConference contributionpeer-review

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 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 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 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.

Original languageEnglish
Title of host publicationClinical Lymphoma Myeloma and Leukemia
Subtitle of host publicationProceedings of the Society of Hematologic Oncology 2022 Annual Meeting
PagesS347
Volume22
EditionS2
DOIs
Publication statusPublished - 1 Oct 2022

Publication series

NameClinical Lymphoma, Myeloma and Leukemia
PublisherElsevier BV
ISSN (Print)2152-2650

Keywords

  • antibody–drug conjugate
  • camidanlumab tesirine
  • CD25
  • clinical trial
  • HL
  • Hodgkin lymphoma
  • Trial-in-Progress

Research Beacons, Institutes and Platforms

  • Manchester Cancer Research Centre

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