刚刚！K 药获批首个卵巢癌适应证_老虎社区_美港股上老虎

刚刚！K 药获批首个卵巢癌适应证

丁香园肿瘤时间02-11

当地时间 2 月 10 日，美国 FDA 已批准默沙东重磅 PD-1 抑制剂帕博利珠单抗（Keytruda）的新适应证，联合化疗（可联合或不联合贝伐珠单抗）用于治疗铂耐药的上皮性卵巢癌、输卵管癌或原发性腹膜癌成年患者。值得一提的是，这是免疫治疗在铂耐药复发性卵巢癌领域的重大里程碑，也是帕博利珠单抗获批的首个卵巢癌适应症。截图来源：FDA 官网此次帕博利珠单抗卵巢癌适应症的获批主要是基于关键性 ...

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K drug approved for the first ovarian cancer indication","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"MRK":1.95},"content_text":"当地时间 2 月 10 日，美国 FDA 已批准默沙东重磅 PD-1 抑制剂帕博利珠单抗（Keytruda）的新适应证，联合化疗（可联合或不联合贝伐珠单抗）用于治疗铂耐药的上皮性卵巢癌、输卵管癌或原发性腹膜癌成年患者。值得一提的是，这是免疫治疗在铂耐药复发性卵巢癌领域的重大里程碑，也是帕博利珠单抗获批的首个卵巢癌适应症。截图来源：FDA 官网此次帕博利珠单抗卵巢癌适应症的获批主要是基于关键性 III 期 KEYNOTE-B96 试验结果。KEYNOTE-B96 是首个在铂耐药复发性卵巢癌中采用免疫检查点抑制剂治疗方案的临床试验。该试验共入组约 643 名患者，旨在评估帕博利珠单抗联合化疗（可联合或不联合贝伐珠单抗）用于治疗铂耐药复发性卵巢癌患者中的疗效。KEYNOTE-B96 研究结果显示，在 466 例 PD-L1 表达阳性且 CPS 评分≥1 的肿瘤患者中，帕博利珠单抗组的中位 PFS 为 8.3 个月，安慰剂组为 7.2 个月（HR=0.72；p=0.0014）。帕博利珠单抗组的中位 OS 为 18.2 个月，安慰剂组的中位总生存期为 14.0 个月（HR=0.76；p=0.0053）。在安全性方面，KEYNOTE-B96 研究中帕博利珠单抗联合紫杉醇（无论是否联合贝伐珠单抗）的总体安全性与既往癌症试验中观察到的安全性相似。卵巢癌是全球女性第八大常见癌症，也是第八大癌症死亡原因。这类患者一线治疗的主要目标是尽可能延缓疾病进展，以期达到长期缓解。约 25% 在完成一线铂类化疗后的六个月内会产生耐药性，这种情况被称为原发性铂耐药性卵巢癌，患者预后极差，治疗选择也十分有限。默沙东实验室全球临床开发副总裁 Gursel Aktan 博士曾在新闻稿中表示：“作为首个有数据证明可改善部分铂耐药复发性卵巢癌患者生存期的免疫疗法，这一基于 Keytruda 的治疗方案，有望改变此类铂耐药复发性卵巢癌患者的治疗模式。”小结帕博利珠单抗是默沙东开发的一款抗 PD-1 单抗。自在 2014 年首次获得 FDA 批准以来，该产品已在全球获批数十项适应症，涵盖黑色素瘤、头颈癌、非小细胞肺癌等至少 16 种癌症类型。在国内，帕博利珠单抗已获批 20 项适应症。获批以来，帕博利珠单抗的销售连年上涨，并于 2023 年和 2024 年先后两次问鼎全球药王宝座。不过，帕博利珠单抗的销售额增速已开始放缓，2025 年全球销售额 316.8亿美元，增速仅有 7.46%。Insight 数据库显示，K 药核心序列专利在中国的到期时间是 2028 年 6 月，美国是 2028 年 12 月。不过，默沙东在 2026 年JPM 大会上表示，非常有信心应对Keytruda 专利到期的挑战。目前默沙东正在开展 80 项 III 期临床研究，新的增长动力带来的商业机会是预测的 2028 年 Keytruda 总销售额的两倍多。编辑：馨药","kind":"news","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"2","news_tag":"productRelease","news_rank":0,"symbols":[],"gpt_button":1,"need_auth":false,"code":"91000000","status":"200"},"commentList":[],"hasMoreComments":false,"newsSizeData":{"likeSize":0,"commentSize":0,"repostSize":0,"favoriteSize":0,"likeStatus":false,"favoriteStatus":false},"isCrawlerRequest":true}