Phase II Trial of Bintrafusp Alfa in Subjects with Thymoma and Thymic Carcinoma

Division Of Basic Sciences - Nci

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Abstract

Bintrafusp alfa, a bifunctional fusion protein that targets PD-L1 and transforming growth factor-b (TGF-b). Retrospective analysis of biopsies obtained from 20 patients with stage IV thymic carcinoma and 13 cases of stage III/IV thymoma, showed TGF-b expression in 65% cases of thymic carcinoma and 15% cases of thymoma with a lower median survival among patients with thymic carcinoma (30 months versus 63 months). Based on these data, we developed a phase II study of bintrafusp alfa for patients with recurrent thymic epithelial tumors. Four patients have been enrolled and treated to date (1 thymoma, 3 thymic carcinoma). One partial response and one case of durable disease stabilization have been observed. Treatment is well tolerated with manageable adverse events. In the first stage of the trial 7 patients will be enrolled in each cohort. If 2 or more responses are observed in each cohort, the study will proceed to stage 2. However, accrual will be stopped if less than 2 responses are noted in each cohort among the first 7 patients enrolled.