Date: 2016-03-04
Type of
information: discontinuation of development
phase: 2
Announcement: results
Company: Immunogen (USA) Sanofi (France)
Product: SAR3419 (coltuximab ravtansine)
Action
mechanism:
- antibody drug conjugate (ADC). SAR3419 is an investigational TAP compound that consists of a CD19-binding antibody developed by ImmunoGen with one of the Company's potent cell-killing agents, DM4, attached using one of its engineered linkers. The antibody enables the compound to bind specifically to cancer cells expressing its CD19 target and the DM4 serves to kill these cells.
- SAR3419 is a potential new therapy for the treatment of CD19+ non-Hodgkin's lymphoma (NHL) and other B-cell malignancies. It was created by ImmunoGen and licensed to Sanofi preclinically as part of a broader collaboration between the companies.
Disease: non-Hodgkin's lymphoma (NHL) and other B-cell malignancies
Therapeutic
area: Cancer - Oncology
Country:
Trial
details:
Latest
news:
- • On March 4, 2016, in its annual report, Sanofi has announced that the coltuximab ravtansine (SAR3419) program has been discontinued in Phase II and the rights returned to Immunogen
- • On November 4, 2014, Genzyme announced enrollment of the first patient in a multicenter Phase II clinical trial to evaluate its nvestigational infusion therapy vatelizumab in patients with relapsing remitting multiple sclerosis (RRMS). The trial, called EMPIRE, is designed to assess the efficacy of vatelizumab vs. placebo in RRMS patients. The safety, tolerability and pharmacokinetics of vatelizumab will also be assessed.
- • On June 4, 2012, ImmunoGen has 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. The data reported are from the Phase I evaluation that established the dosing schedule being used with SAR3419 in its Phase II evaluation. 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 (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/m2), 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).
Is
general: Yes
