A phase II, single-arm, multicentre study ...
Document type :
Article dans une revue scientifique
DOI :
PMID :
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Title :
A phase II, single-arm, multicentre study of coltuximab ravtansine (SAR3419) and rituximab in patients with relapsed or refractory diffuse large B-cell lymphoma
Author(s) :
Coiffier, Bertrand [Auteur]
Thieblemont, Catherine [Auteur]
De Guibert, Sophie [Auteur]
Dupuis, Jehan [Auteur]
Ribrag, Vincent [Auteur]
Bouabdallah, Reda [Auteur]
Morschhauser, Franck [Auteur]
Groupe de Recherche sur les formes Injectables et les Technologies Associées - ULR 7365 [GRITA]
Navarro, Robert [Auteur]
Le Gouill, Steven [Auteur]
Haioun, Corinne [Auteur]
Houot, Roch [Auteur]
Casasnovas, Olivier [Auteur]
Holte, Harald [Auteur]
Lamy, Thierry [Auteur]
Broussais, Florence [Auteur]
Payrard, Sandrine [Auteur]
Hatteville, Laurence [Auteur]
Tilly, Herve [Auteur]
Thieblemont, Catherine [Auteur]
De Guibert, Sophie [Auteur]
Dupuis, Jehan [Auteur]
Ribrag, Vincent [Auteur]
Bouabdallah, Reda [Auteur]
Morschhauser, Franck [Auteur]
Groupe de Recherche sur les formes Injectables et les Technologies Associées - ULR 7365 [GRITA]
Navarro, Robert [Auteur]
Le Gouill, Steven [Auteur]
Haioun, Corinne [Auteur]
Houot, Roch [Auteur]
Casasnovas, Olivier [Auteur]
Holte, Harald [Auteur]
Lamy, Thierry [Auteur]
Broussais, Florence [Auteur]
Payrard, Sandrine [Auteur]
Hatteville, Laurence [Auteur]
Tilly, Herve [Auteur]
Journal title :
British journal of haematology
Abbreviated title :
Br. J. Haematol.
Volume number :
173
Pages :
722-730
Publication date :
2016
HAL domain(s) :
Sciences du Vivant [q-bio]
English abstract : [en]
In this phase II, multicentre, single-arm study, 52 patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) received the anti-CD19 antibody-drug conjugate coltuximab ravtansine (55 mg/m(2) ) and rituximab ...
Show more >In this phase II, multicentre, single-arm study, 52 patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) received the anti-CD19 antibody-drug conjugate coltuximab ravtansine (55 mg/m(2) ) and rituximab (375 mg/m(2) ) weekly for 4 weeks, then every 2 weeks for 8 weeks. The primary endpoint was objective response rate (ORR) by International Working Group Criteria. The primary objective was to reject the null hypothesis of an ORR of ≤40%. Among 45 evaluable patients, the ORR was 31·1% (80% confidence interval [CI]: 22·0-41·6%) and the primary objective was not met. The ORR appeared higher in patients with relapsed disease (58·3% [80% CI: 36·2-78·1%]) versus those refractory to their last (42·9% [80% CI: 17·0-72·1%]) or first-line therapy (15·4% [80% CI: 6·9-28·4%]). Median progression-free survival, overall survival and duration of response were 3·9 [80% CI: 3·22-3·98], 9·0 [80% CI: 6·47-13·67] and 8·6 (range: 0-18) months, respectively. The pharmacokinetics of both drugs were unaffected by co-administration. Common adverse events included gastrointestinal disorders (52%) and asthenia (25%). No patients discontinued due to adverse events. In conclusion, coltuximab ravtansine with rituximab was well tolerated and yielded clinical responses in a subset of patients with relapsed/refractory DLBCL.Show less >
Show more >In this phase II, multicentre, single-arm study, 52 patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) received the anti-CD19 antibody-drug conjugate coltuximab ravtansine (55 mg/m(2) ) and rituximab (375 mg/m(2) ) weekly for 4 weeks, then every 2 weeks for 8 weeks. The primary endpoint was objective response rate (ORR) by International Working Group Criteria. The primary objective was to reject the null hypothesis of an ORR of ≤40%. Among 45 evaluable patients, the ORR was 31·1% (80% confidence interval [CI]: 22·0-41·6%) and the primary objective was not met. The ORR appeared higher in patients with relapsed disease (58·3% [80% CI: 36·2-78·1%]) versus those refractory to their last (42·9% [80% CI: 17·0-72·1%]) or first-line therapy (15·4% [80% CI: 6·9-28·4%]). Median progression-free survival, overall survival and duration of response were 3·9 [80% CI: 3·22-3·98], 9·0 [80% CI: 6·47-13·67] and 8·6 (range: 0-18) months, respectively. The pharmacokinetics of both drugs were unaffected by co-administration. Common adverse events included gastrointestinal disorders (52%) and asthenia (25%). No patients discontinued due to adverse events. In conclusion, coltuximab ravtansine with rituximab was well tolerated and yielded clinical responses in a subset of patients with relapsed/refractory DLBCL.Show less >
Language :
Anglais
Audience :
Internationale
Popular science :
Non
Administrative institution(s) :
Université de Lille
CHU Lille
CHU Lille
Collections :
Research team(s) :
Innovation/évaluation des médicaments injectables
Submission date :
2019-02-26T17:07:25Z