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Giovanni Amato

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    MA05 - Update on Clinical Trials and Treatments (ID 123)

    • Event: WCLC 2019
    • Type: Mini Oral Session
    • Track: Mesothelioma
    • Presentations: 1
    • Now Available
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      MA05.07 - Efficacy and Safety of Re-Treatment with Tremelimumab and Durvalumab Within the NIBIT-MESO-1 Study (Now Available) (ID 1867)

      13:30 - 15:00  |  Author(s): Giovanni Amato

      • Abstract
      • Presentation
      • Slides


      Targeting immune-checkpoint inhibitors (ICI) had proven effective in a variety of tumor types. However, primary and secondary resistance to treatment is emerging as a major limitation of ICI therapy, and scattered information is available on the therapeutic efficacy of re-treatment in ICI-resistant subjects. Here we investigated the efficacy and safety of re-treatment with tremelimumab and durvalumab in malignant mesothelioma (MM) patients who developed resistance to these agents in the phase II NIBIT-MESO-1 study (Calabrò L et al, Lancet Resp Med 2018).


      Patients eligible for re-treatment per the NIBIT-MESO-1 protocol were those who completed 4 dosing cycles of tremelimumab combined with durvalumab, and achieved partial response (PR) or stable disease (SD), followed by progressive disease (PD) during the maintenance with durvalumab or the follow-up phase. Subjects who met the re-treatment criteria received tremelimumab (1 mg/Kg, i.v.) and durvalumab (20 mg/Kg, i.v.) every 4 weeks (Q4W) for 4 doses (re-induction phase), followed by durvalumab (20 mg/Kg, i.v.) Q4W for additional 9 doses (maintenance phase). Objective response rate (ORR), disease control rate (DCR), per immune-related (ir)-modified RECIST criteria, overall survival (OS), and safety were evaluated. Adverse events (AEs) were recorded according to CTC v4.0.


      Seventeen (42.5%) of the 40 MM patients enrolled in the NIBIT-MESO-1 study met the criteria for re-treatment and received therapy. Among them 8 (47%) completed the re-induction phase, 7 (41.2.%) went on maintenance phase, and 1 (5%) entered the follow-up phase. As of April 1st 2019, 16/17 patients were discontinued during re-treatment because of PD, and 7 received additional lines of therapy. Seven out of the 17 (41.2%) re-treated subjects had an irSD, while no ir-ORR were observed. At a median follow-up of 35.8 months, median OS of re-treated patients was significantly (p=0.005) higher (25.6 months, 95% CI: 6.1-45.1) as compared to the 23 subjects who were not re-treated (9.9 months, 95% CI: 7.7-12.1). Grade 1-2 irAEs occurred in 6/17 (35%) re-treated patients, were most frequently dermatological and reversible per protocol guideline; no grade 3-4 irAEs were observed.


      Re-treatment with tremelimumab and durvalumab of MM patients who developed resistance to therapy in the course of the NIBIT-MESO-1 study is clinically effective and safe in a sizeable proportion of re-treated subjects.

      Clinical trial infomation: NCT02588131

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