Identification of a biomarker for anti-PD1 antibody-related clinical effect based on the measurement of quantitative and qualitative change of T cells

2018 Fiscal Year Final Research Report

• Project/Area Number: 17K15506
• Research Category: Grant-in-Aid for Young Scientists (B)
• Allocation Type: Multi-year Fund
• Research Field: Medical pharmacy
• Research Institution: The University of Tokushima
• Principal Investigator: OKADA Naoto 徳島大学, 病院, 薬剤師 (30623269)
• Project Period (FY): 2017-04-01 – 2019-03-31
• Keywords: 抗PD1抗体 / 個別化投与法 / 免疫関連有害事象

Outline of Final Research Achievements

The aim of this study was to identify a biomarker for anti PD1 antibody-related clinical effect based on the measurement of quantitative and qualitative change of T cells. We conducted a multicenter retrospective study to explore the biomarker to predict the clinical effect and immune-related adverse events induced by nivolumab, anti-PD1 antibody. We identified the increase in baseline peripheral lymphocyte count at the time of onset of irAEs was significantly greater in the irAEs-positive group than in the irAEs-negative group after 4 cycles of nivolumab treatment. Our multicenter retrospective study also clarified the dichotomous relationship between irAEs induced by nivolumab in early phase and clinical efficacy in melanoma patients. These results indicated that the early detection of irAEs based on lymphocyte count monitoring and adequate management of irAEs would allow achieving the maximum clinical response with nivolumab treatment in melanoma patients.

Free Research Field

医療薬学

Academic Significance and Societal Importance of the Research Achievements

抗PD1抗体の治療を最適化するためには、臨床現場で応用可能な治療効果予測バイオマーカーが必要になる。本解析から末梢血リンパ球の量的変化を指標にすることで抗PD1抗体薬による免疫関連有害事象を早期に予測することが可能であることが示された。末梢血リンパ球数の測定には特別な検査機器は必要なく、臨床応用性が高いバイオマーカーである。そのため、本解析により得られた知見は、応用性の高い知見であり、臨床に即座に還元可能である。