Subcutaneous versus intravenous nivolumab for renal cell carcinoma.

Nivolumab intravenous noninferiority renal cell carcinoma subcutaneous

Journal

Annals of oncology : official journal of the European Society for Medical Oncology
ISSN: 1569-8041
Titre abrégé: Ann Oncol
Pays: England
ID NLM: 9007735

Informations de publication

Date de publication:
09 Sep 2024
Historique:
received: 25 07 2024
revised: 29 08 2024
accepted: 03 09 2024
medline: 18 9 2024
pubmed: 18 9 2024
entrez: 17 9 2024
Statut: aheadofprint

Résumé

The evolving oncology treatment paradigm has created an unmet need for administration options that improve patient experiences and healthcare efficiencies. CheckMate 67T (NCT04810078) was a phase 3, open-label, multicenter, noninferiority trial in which patients with advanced/metastatic clear cell renal cell carcinoma were randomized to subcutaneous nivolumab (1200 mg every 4 weeks; coformulated with recombinant human hyaluronidase PH20 20,000 units) or intravenous nivolumab (3 mg/kg every 2 weeks). Primary objective was to assess the noninferiority of subcutaneous versus intravenous nivolumab by coprimary endpoints determined from a population pharmacokinetics analysis (time-averaged serum concentration over the first 28 days [C Overall, 495 patients were randomized. Relative exposure in the subcutaneous versus intravenous arm reported by the GMR of C Subcutaneous nivolumab was noninferior to intravenous nivolumab based on pharmacokinetics and ORR. No new safety signals were observed.

Sections du résumé

BACKGROUND BACKGROUND
The evolving oncology treatment paradigm has created an unmet need for administration options that improve patient experiences and healthcare efficiencies.
PATIENTS AND METHODS METHODS
CheckMate 67T (NCT04810078) was a phase 3, open-label, multicenter, noninferiority trial in which patients with advanced/metastatic clear cell renal cell carcinoma were randomized to subcutaneous nivolumab (1200 mg every 4 weeks; coformulated with recombinant human hyaluronidase PH20 20,000 units) or intravenous nivolumab (3 mg/kg every 2 weeks). Primary objective was to assess the noninferiority of subcutaneous versus intravenous nivolumab by coprimary endpoints determined from a population pharmacokinetics analysis (time-averaged serum concentration over the first 28 days [C
RESULTS RESULTS
Overall, 495 patients were randomized. Relative exposure in the subcutaneous versus intravenous arm reported by the GMR of C
CONCLUSION CONCLUSIONS
Subcutaneous nivolumab was noninferior to intravenous nivolumab based on pharmacokinetics and ORR. No new safety signals were observed.

Identifiants

DOI: 10.1016/j.annonc.2024.09.002 PMID: 39288844
pubmed: 39288844
pii: S0923-7534(24)03996-6
doi: 10.1016/j.annonc.2024.09.002
pii:
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Informations de copyright

Copyright © 2024. Published by Elsevier Ltd.

Auteurs

L Albiges (L)

Department of Oncology, Institut Gustave Roussy, Villejuif, France. Electronic address: Laurence.ALBIGES@gustaveroussy.fr.

M T Bourlon (MT)

Urologic Oncology Clinic, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.

M Chacón (M)

Department of Oncology, Instituto Medico Especializado Alexander Fleming, Buenos Aires, Argentina.

H J Cutuli (HJ)

Uro-oncology Research Unit, Hospital Sirio Libanês, Buenos Aires, Argentina.

Y A L Chuken (YAL)

iCan Oncology Center, Monterrey, Mexico.

B Żurawski (B)

Department of Outpatient Chemotherapy, Prof. Franciszek Łukaszczyk Oncology Centre, Bydgoszcz, Poland.

J M Mota (JM)

Instituto do Cancer do Estado de São Paulo, University of São Paulo, São Paulo, Brazil.

I Magri (I)

Centro Privado de RMI Rio Cuarto SA II, Rio Cuarto, Argentina.

M Burotto (M)

Medical Oncology Department, Centro de Investigación Clínica Bradford Hill, Santiago de Chile, Chile.

M Luz (M)

IOP Instituto de Oncologia do Paraná, Curitiba, Brazil.

J de Menezes (J)

Department of Oncology, Hospital Nossa Senhora da Conceição, Porto Alegre, Brazil.

E P Y Ruiz (EPY)

School of Medicine, Department of Oncology, Universidad de la Frontera, Temuco, Chile.

S Fu (S)

Auckland City Hospital, Auckland, New Zealand; Department of Oncology, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand.

M Richardet (M)

Fundacion Richardet Longo, Instituto Oncologico de Cordoba, Cordoba, Argentina.

B P Valderrama (BP)

Hospital Universitario Virgen del Rocio, Department of Medical Oncology, Sevilla, Spain.

M Maruzzo (M)

Oncology 1 Unit, Department of Oncology, Istituto Oncologico Veneto, IOV-IRCCS, Padova, Italy.

S Bracarda (S)

Medical Oncology Department, Azienda Ospedaliera Santa Maria, Terni, Italy.

M Breckenridge (M)

Bristol Myers Squibb, Princeton, NJ, USA.

H E Vezina (HE)

Bristol Myers Squibb, Princeton, NJ, USA.

D Rathod (D)

Bristol Myers Squibb, Princeton, NJ, USA.

Z Yu (Z)

Bristol Myers Squibb, Princeton, NJ, USA.

Y Zhao (Y)

Bristol Myers Squibb, Princeton, NJ, USA.

M Dixon (M)

Bristol Myers Squibb, Princeton, NJ, USA.

D Perumal (D)

Bristol Myers Squibb, Princeton, NJ, USA.

S George (S)

Department of Medicine, Roswell Park Comprehensive Cancer Center, Buffalo, NY, USA.

Classifications MeSH