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A phase II, single-arm, multicentre study of coltuximab ravtansine (SAR3419) and rituximab in patients with relapsed or refractory diffuse large B-cell lymphoma

Bertrand Coiffier 1 Catherine Thieblemont 2 Sophie de Guibert 3 Jehan Dupuis Vincent Ribrag 4 Reda Bouabdallah 5 Franck Morschhauser 6 Robert Navarro 7 Steven Le Gouill Corinne Haioun 8 Roch Houot 9, 10 Olivier Casasnovas 11 Harald Holte Thierry Lamy 12, 3 Florence Broussais 5 Sandrine Payrard Laurence Hatteville Hervé Tilly 13
1 Service d'Hematologie
2 Gvh et Gvl : Physiopathologie Chez l'Homme et Chez l'Animal, Incidence et Role Therapeutique
3 CHU Pontchaillou [Rennes]
4 Laboratoire de recherche translationnelle
Direction de la recherche [Gustave Roussy]
5 Département d'Hematologie
6 Service d'hématologie
7 Service d'hématologie et oncologie médicale
8 Service d'hématologie clinique
9 MiCa - Microenvironnement et cancer
10 Service d'hématologie clinique
11 Hôpital du Bocage
12 CIC - Centre d'Investigation Clinique [Rennes]
13 GPL - Groupe d'étude des proliférations lymphoïdes
Abstract : 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/m2) and rituximab (375 mg/m2) 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
Keywords : antibody–drug conjugate CD19 maytansinoid resistance Lymphoma
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Journal articles
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https://hal-univ-rennes1.archives-ouvertes.fr/hal-01295660
Contributor : Laurent Jonchère <>
Submitted on : Thursday, March 31, 2016 - 2:16:57 PM
Last modification on : Wednesday, August 19, 2020 - 11:17:12 AM

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UNIV-RENNES1 | UNIV-PARIS7 | HCL | PAOLI_CALMETTES | UPEC-UPEM | U917 | CIC | CIC203 | COMUE-NORMANDIE | FNCLCC | IGR | BIOSIT | UR1-UFR-SVE | USPC | UNIV-PARIS-SACLAY | MICMAC | CHLS | UNIV-RENNES | UNIROUEN | UNIV-MONTPELLIER | UPEC | UNIV-PARIS | GPMCND

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Bertrand Coiffier, Catherine Thieblemont, Sophie de Guibert, Jehan Dupuis, Vincent Ribrag, et al.. A phase II, single-arm, multicentre study of coltuximab ravtansine (SAR3419) and rituximab in patients with relapsed or refractory diffuse large B-cell lymphoma. British Journal of Haematology, Wiley, 2016, 173 (5), pp.722-730. ⟨10.1111/bjh.13992⟩. ⟨hal-01295660⟩

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