Data from a Phase I study published last week in the Journal of Clinical Oncology showed that Bayer’s investigational compound anetumab ravtansine (BAY 94-9343), an antibody-drug conjugate comprising an anti-mesothelin antibody linked to maytansinoid DM4, was well tolerated in patients with advanced, metastatic, or recurrent solid tumors that expressed the tumor-differentiation antigen mesothelin.
The data also indicated “a positive trend,” suggesting that high mesothelin expression may be useful for predicting which cancer patients will benefit from anetumab ravtansine.
The study, led by Raffit Hassan of the National Cancer Institute, enrolled 148 patients with solid tumors. Tumor response was evaluated in 138 of the 148 patients enrolled in the study. Overall, 66 patients had stable disease, 11 patients had a partial response, and one patient achieved a complete response.
The overall response rate was 16 percent in the 6.5 mg/kg once-every-3-weeks dosing cohort, 9 percent in the 1.8 mg/kg once-per-week dosing cohort, and 6 percent in the 2.2 mg/kg once-per-week dosing cohort. The disease control rate was 65 percent, 54 percent, and 64 percent, respectively. In the ovarian cancer subgroup, one patient achieved complete response at the 2.2 mg/kg once-per-week dosage.
The highest overall response rate of 31 percent was observed in the 6.5 mg/kg once-every-3-weeks mesothelioma subgroup. Disease control rate in this group was 75 percent.
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