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• W2896984078 abstract "Background: Malignant Pleural Mesothelioma (MPM) is a rare and highly aggressive malignancy with poor prognosis and no treatment is approved for patients (pts) progressing after 1st line pemetrexed-platinum doublet. Nivolumab has previously shown promising activity in 2nd/3rd line Japanese pts with MPM: Goto Y, et al. WCLC2017. Here, we report additional analysis by PD-L1 expression and its relationship to the efficacy and safety of nivolumab in the MERIT study. Methods: Advanced or metastatic 2nd/3rd line pts with MPM previously treated with pemetrexed-platinum doublet were enrolled in the MERIT study. Eligibility criteria also included histologically-confirmed, unresectable MPM without prior surgery, measurable disease, and PS 0-1. There was no restriction for study inclusion based on PD-L1 expression. Pts received nivolumab 240 mg flat dose Q2W until progression or unacceptable toxicity. The primary endpoint was the objective response rate (ORR) evaluated by modified RECIST criteria by an independent review committee, expected ORR was 19.2%. Median follow-up was 6.7 months. Results: PD-L1 status was evaluated in 34 pts, and its expression prevalence was PD-L1 (≥1%)/ PD-L1 (<1%)/not evaluable: 58.8%/35.3%/5.9%. ORR was 29.4% [n = 10/34, 95%CI: 16.8-46.2] in all pts, 40.0% [n = 8/20, 21.9-61.3] in PD-L1 (≥1%) and 8.3% [n = 1/12, 1.5-35.4] in PD-L1 (<1%). Median progression free survival (PFS) was 6.1 months [95%CI: 2.9-NR] in all pts, 7.2 months [2.8-NR] in PD-L1 (≥1%) and 2.9 months [1.4-NR] in PD-L1 (<1%). Median overall survival (OS) has not been reached regardless of tumor PD-L1 expression. Twenty-three (67.6%) pts experienced treatment-related adverse events (TRAEs). Seven (20.6%) pts experienced grade 3 or 4 TRAEs, of whom PD-L1 expression was positive (≥1%) in 6 pts and was not evaluable in one pt. Conclusion: Single-agent nivolumab showed efficacy and safety in 2nd/3rd line pts with MPM. There were higher responses in PD-L1 positive pts. All TRAEs were manageable." @default.
• W2896984078 created "2018-10-26" @default.
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• W2896984078 date "2018-10-01" @default.
• W2896984078 modified "2023-10-03" @default.
• W2896984078 title "A phase II study of nivolumab: a multicenter, open-label, single arm study in malignant pleural mesothelioma (MERIT)" @default.
• W2896984078 doi "https://doi.org/10.1093/annonc/mdy374.003" @default.
• W2896984078 hasPublicationYear "2018" @default.
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