{"id":3436,"date":"2021-09-08T10:06:17","date_gmt":"2021-09-08T01:06:17","guid":{"rendered":"https:\/\/clarivate.com\/ja\/?p=3436"},"modified":"2021-09-08T10:06:17","modified_gmt":"2021-09-08T01:06:17","slug":"roches-tecentriq-shows-promise-in-resectable-nsclc-key-takeaways-for-the-market-2","status":"publish","type":"post","link":"https:\/\/clarivate.com\/life-sciences-healthcare\/ja\/blog\/roches-tecentriq-shows-promise-in-resectable-nsclc-key-takeaways-for-the-market-2\/","title":{"rendered":"\u30ed\u30b7\u30e5\u306e\u30c6\u30bb\u30f3\u30c8\u30ea\u30af\u304c\u5207\u9664\u53ef\u80fd\u306aNSCLC\u3067\u6709\u671b\u8996\u3055\u308c\u308b: \u5e02\u5834\u3067\u306e\u91cd\u8981\u306a\u30dd\u30a4\u30f3\u30c8"},"content":{"rendered":"

\u82f1\u8a9e\u539f\u6587\u30b5\u30a4\u30c8<\/a><\/p>\n

\u672c\u8a18\u4e8b\u306f\u82f1\u6587\u30d6\u30ed\u30b0\u3092\u65e5\u672c\u8a9e\u306b\u7ffb\u8a33\u518d\u7de8\u96c6\uff08\u4e00\u90e8\u8ffd\u8a18\u3092\u542b\u3080\uff09\u3057\u305f\u3082\u306e\u3067\u3059\u3002\u672c\u8a18\u4e8b\u306e\u6b63\u5f0f\u8a00\u8a9e\u306f\u82f1\u8a9e\u3067\u3042\u308a\u3001\u305d\u306e\u5185\u5bb9\u30fb\u89e3\u91c8\u306b\u3064\u3044\u3066\u306f\u82f1\u8a9e\u304c\u512a\u5148\u3057\u307e\u3059\u3002<\/span><\/p>\n

 <\/p>\n

\u30ed\u30b7\u30e5\u306e\u4e3b\u529b\u88fd\u54c1\u3067\u3042\u308b\u6297PD-L1\u6cbb\u7642\u85ac\u3067\u3042\u308b\u30c6\u30bb\u30f3\u30c8\u30ea\u30af\u306f\u3001\u5207\u9664\u53ef\u80fd\u306a\u975e\u5c0f\u7d30\u80de\u80ba\u304c\u3093 (NSCLC) \u306e\u30a2\u30b8\u30e5\u30d0\u30f3\u30c8\u6cbb\u7642\u6cd5\u3068\u3057\u3066\u627f\u8a8d\u53d6\u5f97\u3059\u308b\u6700\u521d\u306e\u514d\u75ab\u7642\u6cd5\u306b\u4e00\u6b69\u8fd1\u4ed8\u304d\u307e\u3057\u305f\u3002Drugs to Watch\u2122\u30b7\u30ea\u30fc\u30ba<\/a>\u306e\u4e00\u74b0\u3068\u3057\u3066\u3001\u30af\u30e9\u30ea\u30d9\u30a4\u30c8\u306e\u304c\u3093\u9818\u57df\u30a8\u30ad\u30b9\u30d1\u30fc\u30c8\u3067\u3042\u308bArman Esfandiari\u3001Amardeep Singh\u3001Kurram Nawaz\u304cASCO 2021\u3067\u5171\u6709\u3055\u308c\u305f\u65b0\u3057\u3044\u30c7\u30fc\u30bf\u3068\u3001\u60a3\u8005\u3084\u30e9\u30a4\u30d5\u30b5\u30a4\u30a8\u30f3\u30b9\u4f01\u696d\u3078\u306e\u5f71\u97ff\u3092\u30ec\u30d3\u30e5\u30fc\u3057\u307e\u3059\u3002<\/p>\n

2021\u5e74\u306eASCO\u5e74\u6b21\u7dcf\u4f1a\u3067\u767a\u8868\u3055\u308c\u305f\u7b2c3\u76f8\u8a66\u9a13IMpower010\u306e\u4e3b\u8981\u8a55\u4fa1\u3067\u306f\u3001\u30b7\u30b9\u30d7\u30e9\u30c1\u30f3\u3092\u30d9\u30fc\u30b9\u3068\u3057\u305f\u5316\u5b66\u7642\u6cd5\u306e\u30a2\u30b8\u30e5\u30d0\u30f3\u30c8\u5f8c\u306b\u5b8c\u5168\u5207\u9664\u3055\u308c\u305f\u30b9\u30c6\u30fc\u30b8II-IIIA\u306eNSCLC\u60a3\u8005\u306b\u5bfe\u3057\u3066\u3001\u30c6\u30bb\u30f3\u30c8\u30ea\u30af\u306e\u30a2\u30b8\u30e5\u30d0\u30f3\u30c8\u7642\u6cd5\u304c\u6700\u5584\u306e\u652f\u6301\u7642\u6cd5 (BSC) \u3068\u6bd4\u8f03\u3057\u3066\u3001\u610f\u5473\u306e\u3042\u308b\u81e8\u5e8a\u7684\u5229\u76ca\u3092\u4e0e\u3048\u308b\u3053\u3068\u304c\u793a\u3055\u308c\u307e\u3057\u305f1\u3002\u3053\u308c\u306b\u3088\u308a\u3001\u30c6\u30bb\u30f3\u30c8\u30ea\u30af\u306f\u5207\u9664\u53ef\u80fd\u306aNSCLC\u306b\u304a\u3044\u3066\u6709\u671b\u306a\u52b9\u679c\u3092\u793a\u3059\u521d\u3081\u3066\u306e\u514d\u75ab\u30c1\u30a7\u30c3\u30af\u30dd\u30a4\u30f3\u30c8\u963b\u5bb3\u5264\u3068\u306a\u308a\u307e\u3057\u305f\u3002\u5207\u9664\u53ef\u80fd\u306aNSCLC\u306e\u75c7\u4f8b\u306f\u3001NSCLC\u306e\u5168\u75c7\u4f8b\u306b\u5360\u3081\u308b\u5272\u5408\u306f\u5c11\u306a\u3044\u304c\u3001\u3053\u306e\u3088\u3046\u306a\u72b6\u6cc1\u4e0b\u3067\u306f\u3001\u3088\u308a\u52b9\u679c\u7684\u306a\u6a19\u7684\u7642\u6cd5\u306b\u5bfe\u3059\u308b\u30a2\u30f3\u30e1\u30c3\u30c8\u30cb\u30fc\u30ba\u304c\u9ad8\u304f\u306a\u3063\u3066\u3044\u307e\u3059\u3002\u3053\u3053\u3067\u306f\u3001\u4e3b\u8981\u5e02\u5834 (\u7c73\u56fd\u3001\u6b27\u5dde\u3001\u65e5\u672c) \u304a\u3088\u3073\u4e2d\u56fd\u672c\u571f\u306b\u304a\u3051\u308b\u30c6\u30bb\u30f3\u30c8\u30ea\u30af\u306e\u4eca\u56de\u306e\u7d50\u679c\u306e\u81e8\u5e8a\u7684\u304a\u3088\u3073\u5546\u696d\u7684\u610f\u5473\u5408\u3044\u306b\u3064\u3044\u3066\u7c21\u5358\u306b\u8aac\u660e\u3057\u307e\u3059\u3002<\/p>\n

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2021\u5e743\u6708\u3001\u30ed\u30b7\u30e5\u306f\u3001\u7b2c3\u76f8\u8a66\u9a13\u3067\u3042\u308bIMpower010\u304c\u4e3b\u8981\u8a55\u4fa1\u9805\u76ee\u3067\u3042\u308b\u7121\u75c5\u751f\u5b58\u671f\u9593 (DFS) \u3092\u9054\u6210\u3057\u305f\u3053\u3068\u3092\u767a\u8868\u3057\u3001\u3053\u306e\u7d50\u679c\u304c\u6b27\u7c73\u3067\u306e\u627f\u8a8d\u7533\u8acb\u306e\u57fa\u790e\u3068\u306a\u308b\u3053\u3068\u3092\u767a\u8868\u3057\u307e\u3057\u305f\u3002IMpower010\u306e\u4e8b\u524d\u306b\u4e88\u5b9a\u3055\u308c\u3066\u3044\u305f\u4e2d\u9593\u89e3\u6790\u306e\u7d50\u679c\u306f\u3001ASCO2021\u3067\u660e\u3089\u304b\u306b\u3055\u308c\u307e\u3057\u305f (\u88681) \u3002<\/p>\n

 <\/p>\n

\u88681\uff1aASCO2021\u3067\u767a\u8868\u3055\u308c\u305fIMpower010\u306e\u7b2c3\u76f8\u8a66\u9a13\u306e\u4e3b\u8981\u30c7\u30fc\u30bf<\/strong><\/p>\n\n\n\n\n\n\n\n
Patient populations and enrollment<\/strong><\/td>\nTrial design<\/strong><\/td>\nSelect efficacy data<\/strong><\/td>\nSelect safety data<\/strong><\/td>\n<\/tr>\n<\/thead>\n
\n
    \n
  • Stage IB-IIIA NSCLC after complete resection and adjuvant cisplatin-based doublet chemotherapy.<\/li>\n
  • N = 1,005<\/li>\n<\/ul>\n<\/td>\n
\n
    \n
  • Treatment:<\/strong> Tecentriq (16 cycles, q21d) vs. BSC (randomized 1:1).<\/li>\n
  • Primary endpoint:<\/strong> DFS (tested hierarchically in three primary analysis populations).<\/li>\n
  • Secondary endpoints:<\/strong> OS, percentage disease free at 3 years and 5 years, safety, and PK\/PD.<\/li>\n<\/ul>\n

    Hierarchical statistical analysis:<\/strong><\/p>\n

      \n
    • Step 1: DFS in PD-L1-positive (TC \u2265 1%) stage II-IIIA NSCLC.<\/li>\n
    • Step 2 (if previous step positive): DFS in all-randomized stage II-IIIA NSCLC patients.<\/li>\n
    • Step 3 (if previous step positive): DFS in ITT population (stage IB-IIIA).<\/li>\n
    • Step 4 (if previous step positive): OS in ITT population.<\/li>\n<\/ul>\n<\/td>\n
Among PD-L1-positive (TC <\/strong>\u2265<\/u><\/strong> 1%) stage II-IIIA patients (n = 476):<\/strong><\/p>\n

Tecentriq vs. BSC (median follow-up: 32.8 months):<\/p>\n

    \n
  • Median DFS: NR vs. 35.3 months (HR 0.66; P = 0.004).<\/li>\n<\/ul>\n

    Among all randomized stage II-IIIA patients (n = 882):<\/strong><\/p>\n

    Tecentriq vs. BSC (median follow-up: 32.2 months):<\/p>\n

      \n
    • Median DFS: 42.3 vs. 35.3 months (HR 0.79; P = 0.02).<\/li>\n<\/ul>\n

      Among ITT (stage IB-IIIA) patients:<\/strong><\/p>\n

      Tecentriq vs. BSC (median follow-up: 32.2 months):<\/p>\n

        \n
      • Median DFS: NE vs. 37.2 months (HR 0.81; P = 0.04 [statistical significance boundary not crossed]).<\/li>\n<\/ul>\n

         <\/p>\n

        Exploratory analysis in key NSCLC subpopulations among all randomized stage II-IIIA patients:<\/strong><\/p>\n

        Tecentriq vs. BSC (median follow-up: 32.2 months):<\/p>\n

          \n
        • DFS in PD-L1-high (TC ><\/u> 50%): HR 0.43.<\/li>\n
        • DFS in PD-L1 negative (TC < 1%): HR 0.97.<\/li>\n<\/ul>\n<\/td>\n
Among all patients:<\/strong><\/p>\n

Tecentriq vs. BSC:<\/p>\n

    \n
  • Any cause adverse events: 92.7% vs. 70.7%.<\/li>\n
  • Treatment-related adverse events: 67.7% vs. NA.<\/li>\n
  • Grade 3\/4 adverse events: 21.8% vs. 11.5%.<\/li>\n
  • Treatment-related grade 3\/4 adverse events: 10.7% vs. NA.<\/li>\n
  • Serious adverse events: 17.6% vs. 8.5%.<\/li>\n
  • Treatment-related serious adverse events: 7.5% vs. NA.<\/li>\n
  • Grade 5 adverse events: 1.6% vs. 0.6%.<\/li>\n
  • Treatment-related grade 5 adverse events: 0.8% vs. NA.<\/li>\n
  • Adverse events leading to dose interruption of Tecentriq: 28.7%.<\/li>\n
  • Adverse events leading to discontinuation of Tecentriq: 18.2%.<\/li>\n
  • Immune-mediated adverse events: 51.7% vs. 9.5%.<\/li>\n
  • Grade 3\/4 immune-mediated adverse events: 7.9 vs. 0.6%.<\/li>\n
  • Immune-mediated adverse events requiring the use of corticosteroids: 12.1% vs. 0.8%.<\/li>\n<\/ul>\n<\/td>\n<\/tr>\n
Abbreviations \u2013<\/strong> DFS: disease-free survival; HR: hazard ratio; ITT: intention-to-treat; NA: not applicable; NE: not evaluable; NR: not reached; OS: overall survival; PD-L1: programmed death-ligand 1; PK\/PD: pharmacokinetics\/pharmacodynamics; TC: tumor cell.<\/p>\n

 <\/p>\n

N.B.<\/strong> Prespecified subgroups included age (<65 years vs. ><\/u> 65 years), sex (male vs. female), race (White vs. Asian), ECOG performance status (0 vs. 1), tobacco use history (never vs. previous vs. current), histology (squamous vs. nonsquamous), stage (IIA vs. IIB vs. IIIA), regional lymph node stage (N0 vs. N1 vs. N2), SP263 PD-L1 status (TC ><\/u> 50% vs. TC ><\/u> 1% vs. TC < 1%), EGFR<\/em> mutation status (yes vs. no vs. unknown), and ALK<\/em> rearrangement status (yes vs. no vs. unknown).<\/td>\n<\/tr>\n

Source: Wakelee HA, 20211<\/sup><\/a>.<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

 <\/p>\n

 <\/p>\n

IMpower010\u306e\u30c7\u30fc\u30bf\u304c\u81e8\u5e8a\u7684\u610f\u7fa9\u3092\u6301\u3064\u7406\u7531\u3068\u306f\uff1f<\/strong><\/h3>\n

DFS\u306e\u6539\u5584\u304c\u5fc5\u305a\u3057\u3082\u5168\u751f\u5b58\u671f\u9593 (OS) \u306e\u5ef6\u9577\u306b\u3064\u306a\u304c\u308b\u308f\u3051\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u304c2\u3001NSCLC\u306e\u30a2\u30b8\u30e5\u30d0\u30f3\u30c8\u7642\u6cd5\u3067\u306f\u3001\u5f8c\u7d9a\u306e\u6cbb\u7642\u306b\u3088\u308b\u4ea4\u7d61\u3092\u6392\u9664\u3057\u3066\u6709\u52b9\u6027\u3092\u8a55\u4fa1\u3067\u304d\u308b\u3053\u3068\u3082\u3042\u3063\u3066\u3001DFS\u306f\u9069\u5207\u306a\u4e3b\u8981\u8a55\u4fa1\u9805\u76ee\u3067\u3042\u308b\u3068\u5e83\u304f\u8003\u3048\u3089\u308c\u3066\u3044\u307e\u3059\u3002<\/p>\n

IMpower010\u3067\u306f\u3001\u30c6\u30bb\u30f3\u30c8\u30ea\u30af\u306e\u30a2\u30b8\u30e5\u30d0\u30f3\u30c8\u306b\u3088\u308a\u3001PD-L1\u967d\u6027 (TC\uff1e1%) \u306e\u30b9\u30c6\u30fc\u30b8II-IIIA NSCLC\u306e\u5207\u9664\u4f8b\u3067\u306f\u75c5\u52e2\u518d\u767a\u307e\u305f\u306f\u6b7b\u4ea1\u306e\u30ea\u30b9\u30af\u304c34%\u6e1b\u5c11\u3057\u3001\u7121\u4f5c\u70ba\u306b\u5207\u9664\u3057\u305f\u30b9\u30c6\u30fc\u30b8II-IIIA NSCLC\u306e\u5168\u4f8b\u3067\u306f21%\u6e1b\u5c11\u3057\u307e\u3057\u305f\u3002<\/p>\n