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ARTICLE | Clinical News

Coltuximab ravtansine: Phase II data

June 9, 2014 7:00 AM UTC

Data from 41 patients with relapsed or relapsed/refractory CD19-positive DLBCL in the per protocol (PP) population of the open-label, international Phase II STARLYTE trial showed that once-weekly 55 mg/m 2 IV SAR3419 for 4 weeks and then every other week until disease progression or discontinuation met the primary endpoint of achieving an ORR of >=20% using Cheson 2007 criteria. Specifically, the ORR was 43.9%. In patients with relapsed disease (n=26), the ORR was 53.8%, including 5 complete responses (CRs) and 9 partial responses (PRs), with 69.2% of patients having stable disease (SD) or better. In patients with relapsed/refractory disease (n=15), the ORR was 26.7%, including 1 CR and 3 PRs, with 46.7% of patients having SD or better. Additionally, in a cohort of 14 evaluable patients with primary refractory disease (cancer that had not responded to first-line treatment), SAR3419 led to an ORR of 21.4%, including 1 CR and 2 PRs, with 35.7% of patients having SD or better. SAR3419 had a favorable safety profile with few serious adverse events reported and no grade 3/4 peripheral neuropathy or ocular events observed. Data were presented at the American Society of Clinical Oncology meeting in Chicago. ...