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ARTICLE | Clinical News

Coltuximab ravtansine: Phase II data

January 13, 2014 8:00 AM UTC

Data from 45 evaluable patients with CD19- or CD20-positive relapsed or refractory DLBCL after >=1 standard treatment in an open-label, European Phase II trial showed that 55 mg/m 2 IV SAR3419 plus Rituxan rituximab administered once weekly for 4 weeks and then every other week for 8 weeks led to an ORR of 31.1%, including 4 complete responses (CRs) and 10 partial responses (PRs). Specifically, there were 2 CRs and 5 PRs in patients with relapsed but not refractory disease (n=12), 3 PRs in patients with disease refractory to the last treatment (n=7) and 2 CRs and 2 PRs in patients with primary refractory disease (n=26). OS and PFS data are not yet mature. SAR3419 plus Rituxan was generally well tolerated with asthenia, nausea, cough, diarrhea and weight decrease reported as the most common treatment-emergent adverse events. Grade 3/4 neutropenia occurred in 15.7% of patients and grade 3/4 thrombocytopenia occurred in 9.8% of patients. There was 1 case of grade 3 transaminase increase. The trial enrolled patients with DLBCL that was relapsing or refractory after >=1 standard treatment, including Rituxan, who were not candidates for or who already underwent transplant. Data were reported at the American Society of Hematology meeting in New Orleans. ...