(Nasdaq: IMGN), a biotechnology company, today announced the presentation of new clinical data for the investigational compound, SAR3419, at the American Society of Clinical Oncology (ASCO) annual meeting taking place in Chicago, IL. SAR3419 uses ImmunoGen’s Targeted Antibody Payload (TAP) technology and is a potential treatment for CD19+ non-Hodgkin’s lymphoma (NHL) and other B-cell malignancies. The compound was created by ImmunoGen and licensed to Sanofi as part of a broader collaboration. The data reported today are from the Phase I evaluation that established the dosing schedule being used with SAR3419 in its Phase II evaluation.
“We believe the findings reported today support that SAR3419 has the potential to become an important new therapy for key B-cell malignancies,” commented Daniel Junius, President and CEO. “These findings also add to the growing body of clinical data supporting that the utility of our TAP technology – and the depth of our product opportunities – extend well beyond any one compound to multiple types of cancers, antibodies, and product designs.”
In its Phase I assessment, SAR3419 has been found to demonstrate activity across an array of NHL histological subtypes and in patients with rituximab (Rituxan
)-refractory and -responsive disease.
Alternative dosing schedules were evaluated to establish the recommended Phase II schedule.
The findings reported today (abstract #8057) are from an extension of a weekly dosing Phase I trial. In this extension, SAR3419 was administered weekly for four weeks and then on an every two-week basis for another four doses. The study investigators note that this schedule “demonstrates an improved safety profile compared to prior tested schedules” while preserving antitumor activity:
- When dosed weekly (at 55 mg/m 2), 33% (7/21) of patients had an objective response (a complete response/CR or partial response/PR).
- When the same dose level was administered with this modified schedule, 29% (6/21) of patients had an objective response and another 43% (9/21) had stable disease.
In October 2011, Sanofi advanced SAR3419 into Phase II clinical testing. In Phase II, the compound is being evaluated for the treatment of CD19+ diffuse large B-cell lymphoma (DLBCL) – alone and in combination with rituximab – and for B-cell acute lymphoblastic leukemia (B-ALL).