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news.CuraGen has presented encouraging results from the ongoing Phase I/II study of CR011-vcMMAE for the treatment of unresectable Stage III or Stage IV melanoma.
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As of April 4, 2008, forty patients were treated in this first-in-man Phase I/II study including a total of 32 patients in the Phase I dose-escalation portion of the trial that aimed to identify the safety and maximum tolerated dose of CR011-vcMMAE and eight patients in the ongoing Phase II portion of the study. During Phase I, doses of CR011-vcMMAE between 0.03 mg/kg to 2.63 mg/kg were evaluated and generally well tolerated, with rash and neutropenia emerging at higher doses. A total of 130 treatment cycles were administered (range 2 – 19+ cycles per patient).
Over 80% of the patients treated had Stage IV disease and had received a median of two prior therapies (range 0 – 6). A total of 37 patients from both Phase I and the ongoing Phase II were evaluable for tumor response by Recist criteria. The activity of CR011-vcMMAE was dose dependent with 50% of those patients treated with doses at or above 1.34 mg/kg exhibiting tumor shrinkage and 64% progression-free at 12 weeks compared to 17% with tumor shrinkage seen and 28% progression-free at 12 weeks for patients treated at lower doses.
In the Phase I portion of the study, 13 evaluable patients were treated with doses at or above 1.34 mg/kg of which one confirmed partial response and six patients with stable disease were reported. In the Phase II portion of the study evaluating CR011-vcMMAE 1.88 mg/kg, there were six evaluable patients of which one partial response (confirmatory visit pending at time of presentation) and three patients with stable disease were reported.
The Phase II trial is evaluating the safety and efficacy of CR011-vcMMAE for patients with unresectable Stage III or Stage IV melanoma who have failed no more than one prior line of cytotoxic therapy.
Timothy Shannon, president and CEO of CuraGen, said: “Based on these promising results in melanoma we have expanded the CR011-vcMMAE development program to include a Phase II trial in metastatic breast cancer, and are also exploring additional doses and schedules to further optimize the activity of this antibody-drug conjugate.”