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「肺癌患者における PD-L1 検査の手引き 第2 版 補遺 …

PD-L1 2 2021/02/12.. 2020 10 PD-L1 2020 11 12 .. OptiView PD-L1 (SP142) 2 PD-L1 .. PD-L1 PD- L1 .. 2020 11 12 .. 2. SP142. PD-L1 .. TC33 or IC34.. 22C3.. TPS5 1%.. 28-8. (22C3). + PD-L1 <1%6. SP142. PD-L1 . TC1/2/3 or IC1/2/3. 28-8. 22C3. PD-L1 1%.. SP263.. PD-L1 1%. 1.. PD-L1 . + . + . + .. + + .. 1.. 2. PD-L1 .. 3. TC3 PD-L1 PD-L1 . 50% . 4. IC3 PD-L1 PD-L1 . 10% . 5. Tumor proportion score PD-L1 . 6. PD-L1 22C3 . 2 PD-L1 .. BMS MSD ROCHE AstraZeneca Dako 28-8 Dako 22C3 VENTANA SP142 VENTANA SP263.. 1% TC3 or IC3. TPS 50%. 5% TC1/2/3 or 1%. TPS 1%. 10% IC1/2/3.

2. pd-l1 検査について 従来、sp142 抗体、28-8 抗体によるpd-l1 検査はそれぞれ二次治療以降においてアテゾリズマブ、ニボルマブを使 用する際に参考とする体外診断薬として承認されていた。上記の臨床試験の結果およびそれに伴う薬剤承認からpd-

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Transcription of 「肺癌患者における PD-L1 検査の手引き 第2 版 補遺 …

1 PD-L1 2 2021/02/12.. 2020 10 PD-L1 2020 11 12 .. OptiView PD-L1 (SP142) 2 PD-L1 .. PD-L1 PD- L1 .. 2020 11 12 .. 2. SP142. PD-L1 .. TC33 or IC34.. 22C3.. TPS5 1%.. 28-8. (22C3). + PD-L1 <1%6. SP142. PD-L1 . TC1/2/3 or IC1/2/3. 28-8. 22C3. PD-L1 1%.. SP263.. PD-L1 1%. 1.. PD-L1 . + . + . + .. + + .. 1.. 2. PD-L1 .. 3. TC3 PD-L1 PD-L1 . 50% . 4. IC3 PD-L1 PD-L1 . 10% . 5. Tumor proportion score PD-L1 . 6. PD-L1 22C3 . 2 PD-L1 .. BMS MSD ROCHE AstraZeneca Dako 28-8 Dako 22C3 VENTANA SP142 VENTANA SP263.. 1% TC3 or IC3. TPS 50%. 5% TC1/2/3 or 1%. TPS 1%. 10% IC1/2/3.

2 CPS1 IC .. CPS . 1. CPS Combined Positive Score PD-L1 / 100. 1.. CheckMate227 CheckMate-9LA PD-L1 . 1) 2) . PD-L1 1% 3) . IMpower110 PD-L1 TC3 or IC3 . 4) . 2. PD-L1 . SP142 28-8 PD-L1 . PD- L1 . IMpower110 TC3/IC3 . 1. SP142 TC3 PD-L1 50% . 1 IMpower110 TC3 or IC3 2016 TC1/2/3 or IC1/2/3 . TC3 or IC3 TC2/3 or IC2/3 TC1/2/3 or IC1/2/3 . TC3/IC3 TC2/3 or IC2/3 ( = ) IC1/2/3 or IC1/2/3 TC3. or IC3 . IC3 10% TC3 IC3 .. Checkmate227 Part 1b PD-L1 . 1 1 1 . progression-free survival PFS . PD-L1 . PD-L1 . 3.. 5)6) . PD-L1 . 7) PD-L1 28-8. 28-8 22C3 . 22C3.

3 22C3 .. 1. Hellmann MD, Paz-Ares L, Bernabe Caro R, Zurawski B, Kim SW, Carcereny Costa E, et al. Nivolumab plus Ipilimumab in Advanced Non-Small-Cell Lung Cancer. N Engl J Med. 2019;381(21):2020-31. 2. Paz-Ares L, Ciuleanu TE, Cobo M, Schenker M, Zurawski B, Menezes J, et al. First-line nivolumab plus ipilimumab combined with two cycles of chemotherapy in patients with non-small-cell lung cancer (CheckMate 9LA): an international, randomised, open-label, phase 3 trial. Lancet Oncol. 2021. 3. Hellmann MD, Ciuleanu TE, Pluzanski A, Lee JS, Otterson GA, Audigier-Valette C, et al.

4 Nivolumab plus Ipilimumab in Lung Cancer with a High Tumor Mutational Burden. N Engl J Med. 2018;378(22):2093-104. 4. Herbst RS, Giaccone G, de Marinis F, Reinmuth N, Vergnenegre A, Barrios CH, et al. Atezolizumab for First-Line Treatment of PD-L1 -Selected Patients with NSCLC. N Engl J Med. 2020;383(14):1328-39. 5. 6. 7.


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