Durvalumab (D) plus Tremelimumab (T) for the treatment of patients with progressive, advanced medullary thyroid carcinoma (MTC) – DUTHY (GETNE-T1812) trial

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Introduction: Evidence for immunotherapy (IT) in patients (pts) with MTC is limited and has shown modest activity.

Aim(s): DUTHY trial aims to evaluate the efficacy and safety of D+T in MTC.

Materials and methods: Pts with advanced thyroid cancers were recruited in three cohorts: differentiated thyroid cancer, MTC and anaplastic thyroid cancer. No prior IT was allowed. Pts received D 1500 mg and T 75 mg every 4 weeks, up to 4 cycles, followed by durvalumab monotherapy until confirmed disease progression, or unacceptable toxicity. Here we present data from the MTC cohort. Primary objective was the 6-month (m) progression-free survival (PFS) rate. Secondary objectives included safety and efficacy in terms of Objective Response Rate (ORR) per RECIST, median PFS and overall survival (OS). The expected accrual was 37 pts, using a Simon II design with H0 of 25% 6-m PFS rate and H1 of 45% (α=0.05, β=0.2).

Conference:

Presenting Author:

Authors: García-Álvarez A, Molina-Cerrillo J, Castelo B, Plana M, Iglesias L,

Keywords: Medullary thyroid carcinoma, Immunotherapy, durvalumab, tremelimumab, anti PD-L1, anti CTLA-4,