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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)
C. Carlo-Stella, S. Ansell, PL. Zinzani, J. Radford, K. Maddocks, A. Pinto, GP. Collins, V. Bachanova, N. Bartlett, I. Bence-Bruckler, M. Hamadani, J. Kline, J. Mayer, KJ. Savage, R. Advani, P. Calmi, RO. Casasnovas, T. Feldman, B. Hess, M....
Jazyk angličtina Země Spojené státy americké
Typ dokumentu klinické zkoušky, fáze II, časopisecké články, multicentrická studie
- MeSH
- brentuximab vedotin MeSH
- dospělí MeSH
- exantém * chemicky indukované farmakoterapie MeSH
- Hodgkinova nemoc * farmakoterapie patologie MeSH
- imunoglobulin G MeSH
- imunokonjugáty * škodlivé účinky MeSH
- lidé MeSH
- lokální recidiva nádoru farmakoterapie MeSH
- monoklonální protilátky terapeutické užití MeSH
- polyradikulopatie * chemicky indukované farmakoterapie MeSH
- protinádorové látky * terapeutické užití MeSH
- Check Tag
- dospělí MeSH
- lidé MeSH
- mužské pohlaví MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky, fáze II MeSH
- multicentrická studie MeSH
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.
ADC Therapeutics America Inc Murray Hill USA
ADC Therapeutics SA Epalinges Switzerland
BC Cancer and University of British Columbia Department of Medical Oncology Vancouver Canada
BMT and Cellular Therapy Program Department of Medicine Medical College of Wisconsin Milwaukee USA
Cleveland Clinic Case Comprehensive Cancer Center Cleveland USA
Department of Hematology University Hospital F Mitterrand and Inserm UMR Dijon France
Division of Hematology Oncology and Transplantation University of Minnesota Minneapolis USA
Division of Oncology Department of Medicine Stanford University Stanford USA
Institute of Hematology Seràgnoli University of Bologna Bologna Italy
Istituto Nazionale Tumori Fondazione G Pascale IRCCS Naples Italy
John Theurer Cancer Center Hackensack Meridian Health Hackensack USA
Mayo Clinic Division of Hematology Rochester USA
Ohio State University Medical Center Division of Hematology Columbus USA
Royal Marsden Hospital London United Kingdom
The Ottawa Hospital General Campus Ottawa Hospital General Campus Ottawa Canada
The University of Chicago Department of Medicine Chicago USA
University Hospital and Masaryk University Brno Czech Republic
Washington University School of Medicine in St Louis Division of Oncology St Louis USA
Citace poskytuje Crossref.org
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- $a 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.
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