Exposure-safety and exposure-efficacy analyses of polatuzumab vedotin in patients with relapsed or refractory diffuse large B-cell lymphoma.
Polatuzumab vedotin
diffuse large B-cell lymphoma
dose justification
exposure-response
pharmacokinetics
relapsed/refractory
Journal
Leukemia & lymphoma
ISSN: 1029-2403
Titre abrégé: Leuk Lymphoma
Pays: United States
ID NLM: 9007422
Informations de publication
Date de publication:
12 2020
12 2020
Historique:
pubmed:
25
7
2020
medline:
28
4
2021
entrez:
25
7
2020
Statut:
ppublish
Résumé
Exposure-response relationships were investigated to assess the risk/benefit of polatuzumab vedotin (pola) + bendamustine-rituximab (pola + BR) in relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL). Analyses were conducted in pivotal study GO29365 (NCT02257567; BR/pola + BR/pola + BG [BG: bendamustine-obinutuzumab]; 1.8 mg/kg pola, every 3 weeks [Q3W], six cycles), and supportive studies DCS4968g (NCT01290549) and GO27834 (NCT01691898) (pola/pola + R/pola + G; 0.1-2.4 mg/kg pola Q3W; eight-cycle landmark), separately. Exposure was characterized as simulated cycle-6 AUC and
Identifiants
pubmed: 32705923
doi: 10.1080/10428194.2020.1795154
doi:
Substances chimiques
Antibodies, Monoclonal
0
Immunoconjugates
0
polatuzumab vedotin
KG6VO684Z6
Banques de données
ClinicalTrials.gov
['NCT02257567', 'NCT01290549', 'NCT01691898']
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM