(NASDAQ: IMGN), a biotechnology company that develops targeted anticancer therapies using its antibody-drug conjugate (ADC) technology, today announced the presentation of clinical findings with SAR3419 (coltuximab ravtansine) used in combination with Rituxan
(rituximab) to treat diffuse large B-cell lymphoma (DLBCL) that previously had been treated with standard therapies. SAR3419 is a CD19-targeting ADC developed by ImmunoGen and licensed to Sanofi as part of a broader collaboration between the companies. These findings were reported at the annual meeting of the American Society of Hematology (ASH) being held in New Orleans, LA.
The data presented today are from a Phase II trial assessing the activity and safety of SAR3419 when used in combination with Rituxan to treat DLBCL that had previously been treated with standard therapies including Rituxan. A total of 52 patients received SAR3419 and Rituxan in the trial, of which 45 were evaluable for efficacy (the per protocol population).
Nearly three in four (73%) patients enrolled had Stage III/IV disease. Sixty percent (60%) had primary refractory disease and another 16% were refractory to their last treatment regimen; the rest were relapsed but not known to be refractory. Forty percent of the study patients had been treated with three or more prior therapies.
The combination of SAR3419 and Rituxan was found to be generally well tolerated, with no patients discontinuing therapy due to treatment emergent adverse events (TEAEs). The most common TEAEs, of any grade, were asthenia, nausea, cough, diarrhea, and weight decrease. Any ocular events were low grade (1/2), manageable and reversible.
Among the twelve study patients with relapsed but not refractory disease, the objective response rate (ORR) was 58%, with 2 complete responses (CRs) and 5 partial responses (PRs). Among the seven patients with disease refractory to the last treatment, the ORR was 43%, with 0 CRs and 3 PRs reported. Among the 26 patients with primary refractory disease – cancer that had never responded to any treatment – the ORR was 15%, with 2 CRs and 2 PRs reported.