{"id":3707,"date":"2021-12-07T14:58:24","date_gmt":"2021-12-07T05:58:24","guid":{"rendered":"https:\/\/clarivate.com\/ja\/?p=3707"},"modified":"2021-12-07T14:58:24","modified_gmt":"2021-12-07T05:58:24","slug":"paradigm-changing-primary-phase-iii-data-for-malignant-melanoma-what-to-expect-from-relatlimab-in-combination-with-opdivo-2","status":"publish","type":"post","link":"https:\/\/clarivate.com\/life-sciences-healthcare\/ja\/blog\/paradigm-changing-primary-phase-iii-data-for-malignant-melanoma-what-to-expect-from-relatlimab-in-combination-with-opdivo-2\/","title":{"rendered":"\u60aa\u6027\u9ed2\u8272\u816b\u306e\u30d1\u30e9\u30c0\u30a4\u30e0\u30c1\u30a7\u30f3\u30b8\u3068\u306a\u308b\u30d7\u30e9\u30a4\u30de\u30ea\u30fc\u7b2c3\u76f8\u30c7\u30fc\u30bf\uff1a \u30aa\u30d7\u30b8\u30fc\u30dc\u3068\u306e\u4f75\u7528\u306b\u3088\u308b\u30ea\u30e9\u30c8\u30ea\u30de\u30d6\u3078\u306e\u671f\u5f85\u611f"},"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

LISETH PARRA<\/strong>
\nAnalyst, Oncology, Clarivate<\/p>\n

 <\/p>\n

\u30d6\u30ea\u30b9\u30c8\u30eb\u306e\u30ea\u30e9\u30c8\u30ea\u30de\u30d6\/\u30aa\u30d7\u30b8\u30fc\u30dc\uff08\u6297LAG-3\/PD-1\uff09\u7642\u6cd5\u306f\u3001\u60aa\u6027\u9ed2\u8272\u816b\u306b\u5bfe\u3059\u308b\u30aa\u30d7\u30b8\u30fc\u30dc\/\u30e4\u30fc\u30dc\u30a4\uff08PD-1\/CTLA-4\uff09\u963b\u5bb3\u5264\u4f75\u7528\u7642\u6cd5\u306e\u30b7\u30a7\u30a2\u306b\u5272\u3063\u3066\u5165\u308b\u614b\u52e2\u3092\u6574\u3048\u3066\u3044\u307e\u3059\u3002Drugs to Watch\u2122<\/a>\u30b7\u30ea\u30fc\u30ba\u306e\u4e00\u74b0\u3068\u3057\u3066\u3001\u30af\u30e9\u30ea\u30d9\u30a4\u30c8\u306e\u30aa\u30f3\u30b3\u30ed\u30b8\u30fc\u5c02\u9580\u5bb6\u3067\u3042\u308bLiseth Parra\u3068Rachel Webster\u304c\u3001ASCO 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\u306b\u3068\u3063\u3066\u306e\u610f\u5473\u3092\u30ec\u30d3\u30e5\u30fc\u3057\u307e\u3059\u3002<\/em><\/p>\n

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2021\u5e74\u306eASCO\u5e74\u6b21\u7dcf\u4f1a\u3067\u306f\u3001\u30ea\u30f3\u30d1\u7403\u6d3b\u6027\u5316\u907a\u4f1d\u5b503\uff08LAG-3\uff09\u963b\u5bb3\u5264\u3068\u30d7\u30ed\u30b0\u30e9\u30e0\u7d30\u80de\u6b7b1\uff08PD-1\uff09\u963b\u5bb3\u5264\u3092\u4f75\u7528\u3059\u308b\u3053\u3068\u3092\u76ee\u7684\u3068\u3057\u305f\u65b0\u898f\u306e\u514d\u75ab\u30c1\u30a7\u30c3\u30af\u30dd\u30a4\u30f3\u30c8\u963b\u5bb3\u5264\u30ec\u30b8\u30e1\u30f3\u306b\u3064\u3044\u3066\u3001\u8aac\u5f97\u529b\u306e\u3042\u308b\u7b2c3\u76f8\u8a66\u9a13\u7d50\u679c\u304c\u767a\u8868\u3055\u308c\u307e\u3057\u305f1<\/sup>\u3002\u30d6\u30ea\u30b9\u30c8\u30eb\u30fb\u30de\u30a4\u30e4\u30fc\u30ba \u30b9\u30af\u30a4\u30d6\u793e\u306e\u30ea\u30e9\u30c8\u30ea\u30de\u30d6\uff08\u6297LAG-3\u6297\u4f53\uff09\u3068\u30aa\u30d7\u30b8\u30fc\u30dc\uff08\u6297PD-1\u6297\u4f53\uff09\u306e\u4f75\u7528\u7642\u6cd5\u306f\u3001\u5207\u9664\u4e0d\u80fd\u307e\u305f\u306f\u8ee2\u79fb\u6027\u306e\u9032\u884c\u3057\u305f\u60aa\u6027\u9ed2\u8272\u816b\u306b\u5bfe\u3059\u308b\u65b0\u305f\u306a\u30d5\u30ed\u30f3\u30c8\u30e9\u30a4\u30f3\u6cbb\u7642\u306e\u9078\u629e\u80a2\u3068\u3057\u3066\u4f4d\u7f6e\u4ed8\u3051\u3089\u308c\u308b\u3053\u3068\u304c\u671f\u5f85\u3055\u308c\u307e\u3059\u3002<\/p>\n

2021\u5e743\u6708\u3001\u30d6\u30ea\u30b9\u30c8\u30eb\u30fb\u30de\u30a4\u30e4\u30fc\u30ba \u30b9\u30af\u30a4\u30d6\u793e\u306f\u3001\u7b2c3\u76f8\u8a66\u9a13\u3067\u3042\u308bRELATIVITY-047\u8a66\u9a13\u304c\u4e3b\u8981\u8a55\u4fa1\u9805\u76ee\u3067\u3042\u308b\u7121\u5897\u60aa\u751f\u5b58\u671f\u9593\u3092\u9054\u6210\u3057\u3001\u305d\u306e\u7d50\u679c\u3001LAG-3\/PD-1\u963b\u5bb3\u5264\u4f75\u7528\u7642\u6cd5\u304c\u5bfe\u7167\u7fa4\u3067\u3042\u308b\u30aa\u30d7\u30b8\u30fc\u30dc\u5358\u5264\u7642\u6cd5\u3068\u6bd4\u8f03\u3057\u3066\u512a\u308c\u305f\u81e8\u5e8a\u7d50\u679c\u3092\u5f97\u305f\u3053\u3068\u3092\u767a\u8868\u3057\u307e\u3057\u305f2<\/sup>\u3002RELATIVITY-047\u306e\u4e00\u6b21\u30c7\u30fc\u30bf\u89e3\u6790\u7d50\u679c\u306f\u30012021\u5e74\u306eASCO\u3067\u767a\u8868\u3055\u308c\u307e\u3057\u305f<\/a>1<\/sup>\u304c\u3001\u305d\u306e\u7d50\u679c\u306f\u671f\u5f85\u3092\u88cf\u5207\u308b\u3082\u306e\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3067\u3057\u305f\uff08\u88681\uff09\u3002<\/p>\n

 <\/p>\n

\u88681\uff1a2021\u5e74ASCO\u5e74\u6b21\u7dcf\u4f1a\u3067\u767a\u8868\u3055\u308c\u305f\u7b2c3\u76f8KEYNOTE-564\u8a66\u9a13\u306e\u4e3b\u8981\u30c7\u30fc\u30bf2,3,6<\/sup><\/p>\n\n\n\n\n\n\n
Trial (identifier) \/ patient population 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
  • Phase II\/III RELATIVITY-047<\/strong> (NCT03470922)<\/li>\n
  • Previously untreated unresectable or metastatic melanoma; ECOG PS 0-1*<\/li>\n
  • N = 714<\/li>\n<\/ul>\n

     <\/td>\n

\n
    \n
  • Treatment arms:<\/strong><\/li>\n
  • Relatlimab (160 mg IV) + Opdivo (480 mg IV) \u2013 FDC Q4W vs. Opdivo (480 mg IV Q4W)<\/li>\n
  • Primary endpoint:<\/strong> PFS by BICR<\/li>\n
  • Secondary endpoints:<\/strong> OS, ORR by BICR, and biomarkers of response<\/li>\n
  • Unique gated Phase II to III design<\/strong>: interim analysis to assess cumulative patient randomization and PFS by BICR \u2013 OS and ORR remain blinded<\/li>\n<\/ul>\n<\/td>\n
Relatlimab plus Opdivo <\/strong>(n = 355) vs. Opdivo <\/strong>(n = 359)<\/p>\n

Median follow-up: 13.2 months<\/p>\n

    \n
  • Median PFS per BICR<\/strong>:<\/li>\n
  • 10.1 vs. 4.6 months<\/li>\n
  • HR:<\/strong> 0.75 (P <\/em>= 0.005)<\/li>\n
  • 1-yr PFS:<\/strong> 48% vs. 36%<\/li>\n
  • Median PFS (LAG-3<\/strong> > 1%)<\/strong>: 12.6 months (n = 268) vs. 4.8 months (n = 269)<\/li>\n
  • Median PFS (LAG-3<\/strong> < 1%)<\/strong>: 4.8 months (n = 87) vs. 2.8 months (n = 90)<\/li>\n<\/ul>\n

     <\/td>\n

Relatlimab plus Opdivo <\/strong>(n = 355) vs. Opdivo <\/strong>(n = 359)<\/p>\n
    \n
  • Any AE: <\/strong>97% vs. 94%<\/li>\n
  • Grade 3\/4 AEs: <\/strong>4 % vs. 33%<\/li>\n
  • Grade 3\/4 TRAEs: <\/strong>19% vs. 10%<\/li>\n
  • AEs leading to Tx discontinuation: <\/strong>15% vs. 7%; pruritus (23%), fatigue (16-13%)<\/li>\n
  • irAE hepatitis: <\/strong>4 % vs. 1%<\/li>\n
  • irAE hypothyroidism: <\/strong>18 % vs. 14%<\/li>\n<\/ul>\n

     <\/td>\n<\/tr>\n

Note: ECOG, Eastern Cooperative Oncology Group; PS, performance status; IV, intravenous; FDC, fixed-dose combination; PFS, progression-free survival; BICR, blinded independent central review; OS, overall survival; ORR, objective response rate; HR, hazard rate; AE, adverse event; TRAEs, treatment-related adverse events; irAEs, immune-related adverse events.<\/p>\n

*Stratification factors included prespecified subgroups: LAG-3, PD-L1, BRAF<\/em>, and AJCC v8 M stage.<\/p>\n

\u51fa\u5178: Journal of Clinical Oncology<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

 <\/p>\n

RELATIVITY-047\u8a66\u9a13\u306e\u30c7\u30fc\u30bf\u306e\u81e8\u5e8a\u7684\u610f\u7fa9\u306f\uff1f<\/strong><\/h3>\n