Camidanlumab tesirine for relapsed or refractory classic Hodgkin lymphoma: a phase 2 study
Outcomes in classic Hodgkin lymphoma (cHL) have steadily improved; however, additional therapies are needed for patients who relapse or do not respond to novel agents. Here, we report the efficacy and safety of camidanlumab tesirine (Cami), an anti-CD25 antibody-drug conjugate, in patients with relapsed/refractory cHL after brentuximab vedotin/programmed cell death protein 1 inhibitor therapies from the phase 2 ADCT-301-201 study. Eligible patients were adults with cHL who had received ≥3 previous lines of systemic therapy (or ≥2 if ineligible for hematopoietic stem cell transplant). Patients received 45 μg/kg Cami (IV, once every 3 weeks) in cycles 1 to 2, followed by 30 μg/kg IV once every 3 weeks for ≤1 year. The primary end point was overall response rate (ORR) per 2014 Lugano classification. Secondary end points included complete response rate (CRR), progression-free survival (PFS), and overall survival (OS). In total, 117 patients were enrolled with a median age of 37.0 years (range, 19-87). The ORR was 70.1% (95% confidence interval [CI], 60.9-78.2), with a CRR of 33.3% (95% CI, 24.9-42.6). The median PFS was 9.13 months (95% CI, 5.3-15.0); median OS was not reached. Thirty-three (28.2%) patients discontinued treatment because of treatment-emergent adverse events; the most common reasons were skin and subcutaneous tissue disorders (n = 10 [8.5%] patients), infections and infestations (n = 5 [4.3%]), and nervous systems disorders (n = 5 [4.3%]). Guillain-Barré-type or polyradiculopathy-type events occurred in 8 (6.8%) patients. Cami was efficacious in this heavily pretreated population; however, the efficacy was overshadowed by substantial issues with the safety profile. This trial was registered at www.clinicaltrials.gov as #NCT04052997.
Authors
- Luqiang Wang
- Justin Paul Kline (ORCID: https://orcid.org/0000-0002-2967-6448)
- Mehdi Hamadani (ORCID: https://orcid.org/0000-0001-5372-510X)
- John Radford (ORCID: https://orcid.org/0000-0001-7898-2786)
- Tatyana A. Feldman (ORCID: https://orcid.org/0000-0002-4458-2896)
- Yanina Negievich
- Paolo F. Caimi (ORCID: https://orcid.org/0000-0003-1436-0464)
- Kerry J. Savage (ORCID: https://orcid.org/0000-0002-5835-9863)
- Isabelle Bence‐Bruckler (ORCID: https://orcid.org/0000-0002-0468-0280)
- Graham P. Collins (ORCID: https://orcid.org/0000-0001-7170-2104)
- Kami J. Maddocks (ORCID: https://orcid.org/0000-0001-8519-8404)
- Marie Toukam (ORCID: https://orcid.org/0000-0001-7040-712X)
- Jens Wuerthner
- Alex Francisco Herrera (ORCID: https://orcid.org/0000-0002-9665-7415)
- Antonio Pinto (ORCID: https://orcid.org/0000-0002-9425-9026)
- Mariana Bastos‐Oreiro (ORCID: https://orcid.org/0000-0002-9431-4646)
- Brian T. Hess (ORCID: https://orcid.org/0000-0003-0176-2050)
- Sunil Iyengar (ORCID: https://orcid.org/0000-0003-4863-4160)
- Jerzy Dyczkowski
- Carmelo Carlo‐Stella (ORCID: https://orcid.org/0000-0003-3144-0124)
- Melanie Lucero (ORCID: https://orcid.org/0000-0002-2779-7078)
- Stephen M. Ansell (ORCID: https://orcid.org/0000-0003-1244-6758)
- Ranjana H. Advani (ORCID: https://orcid.org/0000-0002-3219-2292)
- Olivier Casasnovas (ORCID: https://orcid.org/0000-0002-1156-8983)
- Veronika Bachanová (ORCID: https://orcid.org/0000-0002-9325-432X)
- Karin Havenith (ORCID: https://orcid.org/0000-0002-0610-4228)
- William Townsend (ORCID: https://orcid.org/0000-0003-3975-2448)
- Serafino Pantano
- Nancy L. Bartlett (ORCID: https://orcid.org/0000-0001-8470-394X)
- Pier Luigi Zinzani (ORCID: https://orcid.org/0000-0002-2112-2651)
- Hans G. Cruz (ORCID: https://orcid.org/0000-0003-4633-7760)
- Marc André
- Árpád Szomor
- Jiří Mayer
Institutions
- Health Canada (CA)
- BC Cancer Agency (CA)
- University College Hospital (GB)
- City Of Hope National Medical Center (US)
- University of Minnesota (US)
- Cleveland Clinic (US)
- Hackensack University Medical Center (US)
- Mayo Clinic (US)
- Humanitas University (IT)
- University College London Hospitals NHS Foundation Trust (GB)
- Institute of Cancer Research (GB)
- Medical University of South Carolina (US)
- University of Ottawa (CA)
- Université de Bourgogne (FR)
- Providence College (US)
- Medical College of Wisconsin (US)
- Washington University in St. Louis (US)
- Masaryk University (CZ)
- Manchester Academic Health Science Centre (GB)
- University of Minnesota System (US)
- Ottawa Hospital (CA)
- Churchill Hospital (GB)
- Spinal Cord Injury BC (CA)
- WinnMed (US)
- University of Manchester (GB)
- Hospital General Universitario Gregorio Marañón (ES)
- University of Chicago (US)
- CHU Dinant Godinne UCL Namur (BE)
- University Hospital Brno (CZ)
- NBE Therapeutics (Switzerland) (CH)
- City of Hope (US)
- Adc Therapeutics (Switzerland) (CH)
- Istituto di Ematologia di Bologna (IT)
- e-Therapeutics (United Kingdom) (GB)
- Royal Marsden Hospital (GB)
- The Christie NHS Foundation Trust (GB)
- PTC Therapeutics (United States) (US)
- UCL Biomedical Research Centre (GB)
- Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale" (IT)
- Maison des Sciences sociales et des Humanités de Dijon (FR)
- Oxford University Hospitals NHS Trust (GB)
- Hackensack Meridian Health (US)
- IRCCS Humanitas Research Hospital (IT)
- Ottawa Hospital Research Institute (CA)
- University College London (GB)
- The Ohio State University (US)
- University of Pecs (HU)
- University of Bologna (IT)
- Stanford University (US)
Publication Details
- Journal
- Blood Advances
- Published
- 2025-08-14
- DOI
- https://doi.org/10.1182/bloodadvances.2024015600
- Citations
- 3
- Primary Topic
- Lymphoma Diagnosis and Treatment
- Type
- article
- Field-Weighted Citation Impact
- 4.41
Funders
- Amgen
- Eli Lilly and Company
- Pfizer
- AstraZeneca
- Sanofi
- Gilead Sciences
- Spectrum Pharmaceuticals
- Celgene
- F. Hoffmann-La Roche
- Regeneron Pharmaceuticals
- BeiGene
- Incyte
- Omeros Corporation
- Seagen
- Astellas Pharma
- University College London Hospitals NHS Foundation Trust
- Swedish Orphan Biovitrum
- Ipsen
- EUSA Pharma
- Genentech
- Kite Pharma
- Pharmacyclics
- Daiichi Sankyo Europe