Anetumab in Thymic Carcinoma

Division Of Basic Sciences - Nci

Investigators

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Abstract

This study is complete. Summary: Mesothelin is expressed in a wide variety of tumors, including mesothelioma, ovarian, pancreatic, gastric/GEJ, non-small cell lung cancer (NSCLC), triple-negative breast cancer, cholangiocarcinoma, and thymic carcinomas. In tissue samples from 34 patients with thymic carcinomas assessed for mesothelin expression, approximately three quarters were positive and of those approximately half had high expression. Anetumab ravtansine (BAY 94-9343), is a novel fully human anti-mesothelin IgG1 antibody conjugated to the maytansinoid tubulin inhibitor DM4 and has shown encouraging anti-tumor activity in mesothelioma and ovarian cancer patients in a phase I study. We enrolled three patients with thymic carcinoma in a multi-institutional, signal-generating study with anetumab ravtansine in six additional high unmet medical need malignancies with mesothelin expression (NCT03102320). Eligibility criteria included age18 years or older, unresectable locally-advanced or metastatic recurrent or relapsing disease, one or more prior lines of therapy, and availability of tumor tissue for mesothelin expression testing. Mesothelin-positive patients with thymic carcinoma received anetumab ravtansine as monotherapy at 6.5 mg/kg IV on a 21-day cycle. Study results are awaited.