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R. Danielli



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    MA 19 - Mesothelioma: Bench to Bedside (ID 680)

    • Event: WCLC 2017
    • Type: Mini Oral
    • Track: Mesothelioma
    • Presentations: 1
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      MA 19.02 - Tremelimumab plus Durvalumab in First- or Second-Line Mesothelioma Patients: Final Analysis of the NIBIT-MESO-1 Study (ID 9202)

      11:05 - 11:10  |  Author(s): R. Danielli

      • Abstract
      • Presentation
      • Slides

      Background:
      The anti-CTLA-4 tremelimumab as monotherapy showed initial signs of activity in second-line malignant mesothelioma (MM) patients (Calabrò et al., Lancet Oncol, 2013; Calabrò et al., Lancet Respir Med, 2015), though it failed to improve the overall survival (OS) of second or third line mesothelioma patients compared to placebo in the DETERMINE study (Maio et al., Lancet Oncol, in press). These results and the efficacy of targeting the PD-1/PD-L1 axis in a variety of tumor types, prompted the NIBIT-MESO-1 study aimed at investigating the activity and safety of tremelimumab combined with the anti-PD-L1 durvalumab in MM patients. Here, we report conclusive efficacy and safety analysis from the fully-enrolled NIBIT-MESO-1 study.

      Method:
      The NIBIT-MESO-1 is a phase II, open-label, single Center study. Forty MM patients received tremelimumab at 1 mg/Kg i.v. every 4 weeks (Q4W) for 4 doses, and durvalumab at 20 mg/Kg i.v. Q4W for 13 doses. Primary objective is immune-related (ir)-objective response rate; secondary are ir-disease control rate, ir-progression free survival, OS, and safety. Tumor assessment per ir-modified RECIST or ir-RECIST 1.1 for pleural or peritoneal MM, respectively, was performed at baseline and q12 weeks. Adverse events (AEs) were recorded according to CTC v4.0.

      Result:
      From October 2015 to October 2016, 40 MM patients (38 pleural and 2 peritoneal), median age 64 years (range 41-80), ECOG performance status 0 (n = 19) or 1 (n = 21) were enrolled in the study. MM histology was epithelioid (n = 32), biphasic (n = 5), sarcomatoid (n = 2) or undefined (n = 1). As of April 2017, 12 first or 28 second-line MM patients received a median of 6 doses of therapy (range = 1-13). Ten ir-objective responses (9 confirmed) were observed (25%), and 25 patients reached an ir-disease control rate (62.5%). The median OS was not reached with a median follow-up of 9.5 months (inter-quartile range: 6.2-12.5 months). Thirty patients (75%) experienced any grade irAEs: grade 1-2 irAEs were observed in 67.5% and grade 3-4 irAEs in 17.5%. AEs were generally manageable and reversible per protocol guidelines.

      Conclusion:
      These data suggest that the combination of tremelimumab and durvalumab is active, with a good safety profile in MM patients, and warrant further exploration. Clinical trial information: .

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