Table 2.
Preclinical and clinical development of SAR3419
| Preclinical studies | Year | Models | ||||
|---|---|---|---|---|---|---|
| Superior antitumor activity of SAR3419 to rituximab in xenograf models for non-Hodgkin’s lymphoma.71 | 2009 | WSU-DLCL/WSU-FSCCL | ||||
| Preclinical evaluation of SAR3419 (huB4-DM4), an anti-CD19-maytansinoid immunoconjugate, for the treatment of B-cell lymphoma.45 | 2006 | Burkitt lymphomas/diffuse large cell lymphoma (ramos lymphoma xenograft model) | ||||
| The anti-CD19 antibody-drug conjugate SAR3419 prevents hematolymphoid relapse postinduction therapy in preclinical models of pediatric acute lymphoblastic leukemia.75 | 2013 | BCP-ALL, T-ALL, and MLL-ALL xenograft model | ||||
| Trial | Phase | Status | Year | Condition | Protocol ID | |
|
| ||||||
| SAR3419 as single agent in relapsed-refractory diffuse large B-celI lymphoma patients | Phase II | Active | 2012 | DLBCL | ARD10248, 2011-003657-26, U1111-1115-3349, NCT01472887 | |
| SAR3419 in acute lymphoblastic leukemia (ALL) | Phase II | Active | 2011 | ALL | EFC11603 U1111-1118-0642, NCT01440179 | |
| Combination of SAR3419 and rituximab in relapsed/refractory diffuse large B-cell lymphoma | Phase II | Active | 2011 | DLBCL | TCD123332011-002865-39, U1111-1120-0315, NCT01470456 | |
| SAR3419 administered weekly in patients with relapsed/refractory CD19-positive B-cell non-Hodgkin’s lymphoma.74 | Phase I | Completed | 2008–2012 | B-NHL | TED6829 EudraCT2007-004868-41, NCT00796731 | |
| Multi-dose-escalation safety and pharmacokinetic study of SAR3419 as single agent in relapsed/refractory B-cell non-Hodgkin’s lymphoma.73 | Phase I | Completed | 2007–2012 | B-NHL | TED6828, NCT00549185 | |
Abbreviations: ALL, acute lymphoblastic leukemia; WSU-DLCL, Wayne State University-diffuse large B-cell lymphoma cell line; WSU-FSCCL, Wayne State University-follicular small cleaved cell lymphoma cell line; B-NHL, B-cell non-Hodgkin’s lymphoma; DLBCL, diffuse large B-cell lymphoma; BCP-ALL, B-cell precursor acute lymphoblastic leukemia; MLL-ALL, mixed lineage acute lymphoblastic leukemia; T-ALL, T-cell acute lymphoblastic leukemia; CD, cluster of differentiation.