[{"_1":2,"_3":-5,"_4":-5},"loaderData",{"_5":6,"_7":8},"actionData","errors","root",{"_99":100},"en-item",{"_9":10,"_10":11},"kind","item",{"_12":13,"_14":15,"_16":17,"_18":19,"_20":21,"_22":23,"_24":25,"_26":27,"_28":29,"_30":31,"_32":31,"_33":34,"_35":36,"_37":38,"_39":40,"_41":42,"_43":44,"_45":46,"_47":-5,"_48":49,"_50":-5,"_51":-5,"_52":53,"_54":55,"_56":57,"_58":42,"_59":42,"_60":61,"_62":42,"_63":64},"id","mh72o64gtfxkoyi5jvkca37vc","revision",2,"title","GSK公布Ris-Rez治疗复发性广泛期小细胞肺癌的首批全球数据：8 mg/kg组客观缓解率为61%","originalTitle","6-K - GSK plc (0001131399) (Filer)","summary","GSK公布其在研抗体偶联药物Ris-Rez治疗复发性广泛期小细胞肺癌的全球首批数据：EMBOLD PanTumour-101 Ib期剂量优化部分中，8 mg/kg组经确认的客观缓解率为61%（11/18），6 mg/kg组为32%（7/22）。","reason","试验报告了不同剂量下的客观缓解率及安全性数据，仍需更长随访以进一步评估缓解持续时间。","source",{"_12":90,"_91":92,"_9":93,"_94":42,"_95":96,"_97":98},"links",{"_87":88,"_78":89},"publishedAt","2026-10-19T11:25:46.000Z","discoveredAt","2026-10-19T11:48:40.669Z","timelineAt","category","industry","tags",[84,85,86],"stockSymbols",[83],"score",76,"selected",true,"channel","news","story",{"_73":74,"_16":75},"x","readingMode","full","author","language","body",{"_64":77,"_78":-5,"_79":80,"_81":82},"outline",[],"relatedStories",[76],"indexable","markdownAvailable","group",{"_65":66,"_45":67,"_68":69,"_70":71,"_72":71},"hasTranslation","bodyLanguage","zh","factId","f4KlbXL2TA14",{"_73":74,"_16":75},"reportCount",1,"additionalSourceCount",0,"developmentCount","publicId","907fa8b7-9687-432d-825a-5f930c485e5f","GSK公布Ris-Rez治疗小细胞肺癌数据",{"_73":74,"_16":75},"

\n\n美国

\n\n证券交易委员会

\n\n华盛顿特区 20549

\n\n6-K 表格

\n\n根据规则 13a-16 或 15d-16 提交的外国私人发行人报告

\n\n根据 1934 年证券交易法

\n\n2026 年 10 月

\n\n委员会\n文件编号 001-15170

\n\n葛兰素史克 plc

\n(注册人名称的英文翻译)

\n\n伦敦新牛津街 79 号，WC1A 1DG

\n\n(主要执行办公室地址)

\n\n请用勾选标记表明注册人是否提交或将在 20-F 或 40-F 表格下提交年度报告。

\n\n20-F . . . .X. . . . 40-F . . . . . . . .

\n\n发布日期：2026 年 10 月 18 日，英国伦敦

\n\n葛兰素史克公布首次针对广泛期小细胞肺癌的瑞斯瑞兹全球数据

\n●

61% 的总体缓解率在 I 期试验中

\n●

结果建立在中国患者中的积极关键数据基础上

\n●

数据支持瑞斯瑞兹的加速开发，包括在广泛期小细胞肺癌的全球 III 期试验中

\n\n\n\n葛兰素史克 plc（伦敦证券交易所/纽约证券交易所：GSK）今天宣布了其研究性 B7-H3 靶向抗体药物偶联物（ADC）瑞斯瑞兹（Ris-Rez）在复发性广泛期小细胞肺癌（ES-SCLC）患者中的首次全球数据。来自 EMBOLD PanTumour-101 试验 I 期剂量优化部分的结果显示了积极的抗肿瘤活性和可管理的安全性，这补充了最近在中国 SCLC 患者中报告的积极 III 期数据。1\n

\n\n在试验中，瑞斯瑞兹在 8 毫克/千克剂量下（n=11/18；95% 置信区间：35.7-82.7）的确认客观缓解率（ORR）为 61%，与 6 毫克/千克剂量下（n=7/22；95% 置信区间：13.9-54.9）的 32% 相比。这些发现将在 2026 年西班牙马德里举行的欧洲肿瘤内科学会（ESMO）大会上以海报展示。结合汉逊的 III 期 ARTEMIS-008 研究在 SCLC 中的数据，这些数据支持了目前在葛兰素史克全球 III 期 EMBOLD SCLC-301 研究中评估的 8 毫克/千克剂量的选择。

\n\n葛兰素史克研发部全球肿瘤负责人高级副总裁 Hesham Abdullah 表示，“瑞斯瑞兹的首次全球数据显示了最近在汉逊关键性中国试验中报告的统计学显著的总体生存获益。随着瑞斯瑞兹数据的不断积累，我们继续专注于加速广泛期小细胞肺癌的开发，因为患者通常会迅速复发，迫切需要更多的治疗选择。”

\n\n在中位随访 100.5 天的情况下，两个剂量水平的安全性均是可管理的。接受 8 毫克/千克剂量的患者中有 42% 出现了 3 级或更高治疗相关不良事件（TRAEs），而接受 6 毫克/千克剂量的患者中有 15% 出现了此类事件，其中血液学事件最为常见。间质性肺病（ILD）的总体发生率较低（2%；50 名患者中 1 名），且为中度（2 级）。

\n\n延世大学癌症中心医学肿瘤科的 Hye Ryun Kim 医学博士、博士表示，“广泛期小细胞肺癌仍然是我们治疗中最具有侵袭性的癌症之一，五年生存率通常在个位数。疾病复发的患者通常选择有限，而目前的治疗方案可能难以耐受。瑞斯瑞兹观察到的缓解率和可管理的安全性令人鼓舞，并支持其在这一领域的持续开发。”

\n\n这些数据将与来自EMBOLD计划的更广泛研究结果一起在ESMO 2026上展示，包括EMBOLD PanTumour-101的全球剂量递增结果、Ris-Rez在Ris-Rez早期临床计划Ris-Rez中的ILD分析，以及全球III期EMBOLD SCLC-301研究的设计。来自RESONANCE研究的真实世界证据进一步表明，在ES-SCLC复发后治疗决策的复杂性，并突显了在后续治疗线中缺乏明确的治疗标准。这些发现共同为Ris-Rez提供了不断增长的证据，并反映了GSK在仍有显著患者需求和科学机会的领域推进靶向药物的重点。

\n\n关于EMBOLD PanTumour-101

\n\nEMBOLD PanTumour-101（NCT06551142）是一项全球性、开放标签的Ia/b期研究，评估Ris-Rez单药治疗在晚期或转移性实体瘤成人患者中的安全性和耐受性以及临床活性。在研究的Ib期剂量优化部分，复发（2L+）的广泛期小细胞肺癌患者被随机分配每三周静脉注射Ris-Rez 6 mg/kg或8 mg/kg，直至疾病进展、不可接受的毒性、失访或死亡。在ESMO 2026上展示的分析包括50名患者，这些患者平均接受了两种既往治疗。研究人群包括有拓扑异构酶-1抑制剂或tarlatamab暴露史的患者，以及有脑或肝转移的患者。在数据截止时，试验Ib期剂量优化部分的入组仍在进行中，需要更长的随访时间来进一步表征反应的持久性。

\n\n关于risvutatug rezetecan

\n\nRis-Rez是一种新型的试验性抗体药物偶联物，靶向B7-H3蛋白，该蛋白在超过10种实体瘤类型中高度表达，支持GSK到2040年在40多种适应症中开发Ris-Rez的雄心。GSK从Hansoh Pharma获得了Ris-Rez的独家全球权利（不包括中国大陆、香港、澳门和台湾），以推进Ris-Rez的临床开发和商业化。截至目前，已有超过1000名患者参与了GSK全球EMBOLD临床试验计划，其中包括晚期广泛期小细胞肺癌（ES-SCLC）和转移性去势抵抗性前列腺癌（mCRPC）的III期试验，还有计划中的早期治疗线SCLC和化疗初治mCRPC的额外III期试验。截至目前，Ris-Rez已获得多项全球监管认定，包括美国、日本和欧盟针对SCLC的孤儿药认定，以及美国针对复发或难治性ES-SCLC的突破性疗法认定和欧洲药品管理局（EMA）的优先药物（PRIME）认定等。2,3,4,5,6

\n\n关于小细胞肺癌

\n\nSmall cell lung cancer (SCLC) is associated with rapid progression\nand accounts for approximately 10-15% of all lung cancer diagnoses\nworldwide.7\nSCLC is characterised by early\nmetastatic spread, frequent relapse and poor\nprognosis.7\nApproximately 70% of patients with\nSCLC are diagnosed with extensive-stage disease (ES-SCLC), meaning\nthe cancer has spread throughout one or both lungs and/or to other\nparts of the body.7,8\nMedian overall survival for patients\nwith ES-SCLC treated with current standard-of-care therapies is\napproximately 12 to 13 months.8\nDespite advances in treatment,\noutcomes for patients with ES-SCLC remain poor and risk of disease\nprogression or recurrence remains high, underscoring the need for\nnew therapies that can improve outcomes for patients facing this\naggressive cancer.

\n\nAbout GSK in oncology

\n\nGSK is focused on developing differentiated medicines for cancers\nwhere patients continue to face poor outcomes, treatment\nresistance, limited options or significant treatment burden. We\nfocus where advances in science and technology offer the greatest\nopportunity to improve outcomes across haematological, lung,\ngastrointestinal, genitourinary and gynaecological cancers. Across\nmultiple modalities, including targeted small molecules,\nantibody-drug conjugates (ADCs) and immunotherapies, GSK applies\ndeep expertise in cancer biology and immune system science to\ndevelop differentiated medicines designed to deliver durable\nresponses, overcome resistance and reduce treatment\nburden.

\n\nAbout GSK

\n\nGSK is a global biopharma company with a purpose to unite science,\ntechnology and talent to get ahead of disease together. Find out\nmore at www.gsk.com.

\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n

\n \n\nGSK enquiries \n	\n\n	\n\n	\n\n
\n \n\nMedia: \n	\n \n\nTim Foley \n	\n \n\n+44 (0) 20 8047 5502 \n	\n \n\n(London) \n
\n\n	\n \n\nSarah Clements \n	\n \n\n+44 (0) 20 8047 5502 \n	\n \n\n(London) \n
\n\n	\n \n\nMadison Goring \n	\n \n\n+44 (0) 20 8047 5502 \n	\n \n\n(London) \n
\n\n	\n \n\nKathleen Quinn \n	\n \n\n+1 202 603 5003 \n	\n \n\n(Washington DC) \n
\n\n	\n \n\nAlison Hunt \n	\n \n\n+1 540 742 3391 \n	\n \n\n(Washington DC) \n
\n\n	\n\n	\n\n	\n\n
\n\n	\n\n	\n\n	\n\n
\n \n\nInvestor Relations: \n	\n \n\nJames Dodwell \n	\n \n\n+44 (0) 7881 269066 \n	\n \n\n(London) \n
\n\n	\n \n\nMick Readey \n	\n \n\n+44 (0) 7990 339653 \n	\n \n\n(London) \n
\n\n	\n \n\nJoanna Tuplin \n	\n \n\n+44 (0) 7788 351650 \n	\n \n\n(London) \n
\n\n	\n \n\nSam Piper \n	\n \n\n+44 (0) 7824 525779 \n	\n \n\n(London) \n
\n\n	\n \n\nDan Smith \n	\n \n\n+44 (0) 7823 523885 \n	\n \n\n(London) \n
\n\n	\n \n\nJeff McLaughlin \n	\n \n\n+1 215 751 7002 \n	\n \n\n(Philadelphia) \n
\n\n	\n \n\nFrannie DeFranco \n	\n \n\n+1 215 751 3126 \n	\n \n\n(Philadelphia) \n

\n\nCautionary statement regarding forward-looking\nstatements

\n\nGSK cautions investors that any forward-looking statements or\nprojections made by GSK, including those made in this announcement,\nare subject to risks and uncertainties that may cause actual\nresults to differ materially from those projected. Such factors\ninclude, but are not limited to, those described in the “Risk\nFactors” section in GSK’s Annual Report on Form 20-F\nfor 2025, and GSK’s Q2 Results for 2026.

\n\nRegistered in England & Wales:

\n\nNo. 3888792

\n\nRegistered Office:

\n\n79 New Oxford Street

\n\nLondon

\n\nWC1A 1DG

\n\nReferences

\n1.

GSK.\nRis-Rez reduced risk of death by 54% versus topotecan in patients\nwith relapsed small cell lung cancer in China.\nhttps://www.gsk.com/en-gb/media/press-releases/ris-rez-reduced-risk-of-death-by-54-versus-topotecan-in-patients-with-relapsed-small-cell-lung-cancer-in-china/

\n2.

GSK.\nGSK receives US FDA Breakthrough Therapy Designation for its\nB7-H3-targeted antibody-drug conjugate in relapsed or refractory\nextensive-stage small-cell lung cancer. Available at:\nhttps://www.gsk.com/en-gb/media/press-releases/gsk-receives-us-fda-breakthrough-therapy-designation/.

\n3.

GSK。\nGSK的针对B7-H3的抗体药物偶联物risvutatug rezetecan在日本获得小细胞肺癌的孤儿药认定。详情请见：\nhttps://www.gsk.com/en-gb/media/press-releases/gsk-s-b7-h3-targeted-antibody-drug-conjugate-risvutatug-rezetecan-granted-orphan-drug-designation-for-small-cell-lung-cancer-in-japan/。

\n4.

GSK。\nGSK的针对B7-H3的抗体药物偶联物GSK’227，在复发的广泛期小细胞肺癌中获得欧洲药品管理局（EMA）优先药物（PRIME）认定。详情请见：\nhttps://www.gsk.com/en-gb/media/press-releases/b7-h3-targeted-antibody-drug-conjugate-receives-ema-priority-medicines-designation-in-relapsed-extensive-stage-small-cell-lung-cancer/。

\n5.

GSK。\nGSK的针对B7-H3的抗体药物偶联物GSK’227，在欧盟获得孤儿药认定。详情请见：\nhttps://www.gsk.com/en-gb/media/press-releases/gsk-s-b7-h3-targeted-antibody-drug-conjugate-gsk-227-receives-orphan-drug-designation-in-the-eu

\n6.

GSK。\nGSK的针对B7-H3的抗体药物偶联物GSK’227，在晚期复发或难治性骨肉瘤中获得美国FDA突破性疗法认定。详情请见：\nhttps://www.gsk.com/en-gb/media/press-releases/gsk-b7-h3-targeted-antibody-drug-conjugate-gsk227-receives-us-fda-breakthrough-therapy-designation-in-late-line-relapsed-or-refractory-osteosarcoma/。

\n7.

Kim S, Park H, Chiang A. 小细胞肺癌：综述。JAMA。\n2025。

\n8.

Saida Y, Watanabe S, Kikuchi T。\n广泛期小细胞肺癌：现状与未来展望。Onco Targets Ther。\n2023。

\n\n签名

\n根据1934年证券交易法的要求，注册人已 duly 促使本报告由下述签署人代表其签署，并已 duly 授权。

\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n

\n\n	\n \n\nGSK plc \n
\n\n	\n \n（注册人） \n
\n\n	\n\n
\n \n日期： 2026年10月\n19日 \n	\n\n
\n\n	\n\n
\n\n	\n \n由：/s/ VICTORIA\nWHYTE \n \n-------------------------- \n
\n\n	\n\n
\n\n	\n \nVictoria Whyte \n
\n\n	\n \n授权\n签署人代表\nGSK plc \n
\n\n	\n \nbehalf\nof GSK plc \n

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