KEYNOTE-905和KEYNOTE-B96研究生存數(shù)據(jù)將在主席研討會(huì)亮相，彰顯帕博利珠單抗在特定膀胱癌和鉑類耐藥復(fù)發(fā)性卵巢癌中的重要作用默沙東創(chuàng)新管線多款在研藥物數(shù)據(jù)將發(fā)布，包括REJOICE-Ovarian01研究評(píng)估raludotatug deruxtecan（R-DXd）用于鉑類耐藥卵巢癌患者的最新結(jié)果帕博利珠單抗在早期及轉(zhuǎn)移性非小細(xì)胞肺癌的長(zhǎng)期數(shù)據(jù)，進(jìn)一步鞏固其在該癌種治療中的基礎(chǔ)地位

? ? ? ?美國(guó)新澤西州羅威市，2025年10月9日——默沙東（默沙東是美國(guó)新澤西州羅威市默克公司的公司商號(hào)）宣布，公司將在10月17日至21日期間于德國(guó)柏林舉行的歐洲腫瘤內(nèi)科學(xué)會(huì)（ESMO）大會(huì)上，發(fā)布來自公司廣泛且差異化產(chǎn)品組合及在研管線的100余篇摘要，涵蓋20余種癌癥類型及多種治療場(chǎng)景。這些數(shù)據(jù)展示了默沙東在多種腫瘤類型領(lǐng)域快速推進(jìn)研究、助力患者改善預(yù)后的堅(jiān)定承諾。

? ? ? “今年ESMO大會(huì)的數(shù)據(jù)再次證明帕博利珠單抗在特定癌癥類型中的持續(xù)影響力和潛力，也見證了我們?cè)诳焖偻七M(jìn)在研管線方面取得的進(jìn)展，尤其是多款在研抗體偶聯(lián)藥物（ADC）的重要數(shù)據(jù)發(fā)布，”默沙東實(shí)驗(yàn)室高級(jí)副總裁、腫瘤學(xué)全球臨床開發(fā)負(fù)責(zé)人Marjorie Green博士表示，“我們尤為自豪的是，今年ESMO大會(huì)上，針對(duì)膀胱癌、卵巢癌和肺癌的腫瘤藥物研究被選入三場(chǎng)主席研討會(huì)進(jìn)行討論。”

? ? ? 此次大會(huì)上公司產(chǎn)品組合發(fā)布的數(shù)據(jù)將包括來自帕博利珠單抗[1]、與衛(wèi)材合作的侖伐替尼[2]、貝組替凡[3]、以及帕博利珠單抗和berahyaluronidase alfa-pmph[4]的全新或更新數(shù)據(jù)。

將在ESMO會(huì)議上公布的默沙東產(chǎn)品組合關(guān)鍵數(shù)據(jù)包括：

III期KEYNOTE-905/EV-303研究首次公布數(shù)據(jù)，評(píng)估帕博利珠單抗聯(lián)合注射用維恩妥尤單抗在手術(shù)前和手術(shù)后用于不適合順鉑治療的肌層浸潤(rùn)性膀胱癌患者（Presentation #LBA2, Proffered paper session: Presidential Symposium I）[5]III期KEYNOTE-B96研究首次公布數(shù)據(jù)，評(píng)估帕博利珠單抗聯(lián)合化療（紫杉醇）±貝伐珠單抗用于鉑類耐藥復(fù)發(fā)性卵巢癌患者（Presentation #LBA3, Proffered paper session: Presidential Symposium I）[6]III期KEYNOTE-775/Study 309研究公布五年探索性隨訪數(shù)據(jù)，評(píng)估帕博利珠單抗聯(lián)合侖伐替尼用于晚期子宮內(nèi)膜癌患者（Presentation #1119P, Poster session: Gynaecological cancers）[7]帕博利珠單抗單藥治療局部晚期或轉(zhuǎn)移性非小細(xì)胞肺癌（NSCLC）患者的10年和8年探索性隨訪數(shù)據(jù)（Presentation #3208P, Poster session: NSCLC, metastatic）III期KEYNOTE-671研究公布五年探索性隨訪數(shù)據(jù)，評(píng)估帕博利珠單抗聯(lián)合含鉑化療新輔助治療并在手術(shù)后繼續(xù)帕博利珠單抗單藥輔助治療早期NSCLC患者（Presentation #LBA67, Mini oral session 2: Non-metastatic NSCLC）II期LITESPARK-015研究A1隊(duì)列首次公布數(shù)據(jù)，評(píng)估貝組替凡用于晚期嗜鉻細(xì)胞瘤和副神經(jīng)節(jié)瘤（PPGL）患者（Presentation #1705O, Proffered paper session: NETs and endocrine tumours）II期MK-3475A-F11研究公布患者報(bào)告的偏好結(jié)果，評(píng)估皮下注射與靜脈注射帕博利珠單抗在多種腫瘤類型中的患者偏好（Presentation #3145P, Poster session: General interest）

? ? ? 此外，將在大會(huì)上發(fā)布的在研管線數(shù)據(jù)包括與第一三共公司共同開發(fā)的ADC藥物raludotatug deruxtecan (R-DXd)[8]和ifinatamab deruxtecan (I-DXd)[9]；以及與科倫博泰公司共同開發(fā)的靶向TROP-2抗體偶聯(lián)物（ADC）藥物蘆康沙妥珠單抗 (sac-TMT)[10]將在4場(chǎng)分享中展示在肺癌、乳腺癌、宮頸癌和前列腺癌特定患者中的研究進(jìn)展。

在ESMO會(huì)議上公布的在研管線關(guān)鍵摘要包括：

II/III期REJOICE-Ovarian01研究公布II期研究劑量?jī)?yōu)化部分?jǐn)?shù)據(jù)，評(píng)估R-DXd用于鉑類耐藥、高級(jí)別卵巢癌、原發(fā)性腹膜癌或輸卵管癌患者（Presentation #LBA42, Proffered paper session: Gynaecological cancers）[11]由第一三共領(lǐng)導(dǎo)的II期IDeate-Lung01研究公布數(shù)據(jù)，評(píng)估I-DXd用于既往治療的廣泛期小細(xì)胞肺癌及基線腦轉(zhuǎn)移患者（Presentation #2760MO, Mini oral session 1: Non-metastatic NSCLC）[11]III期OptiTROP-Lung04研究公布數(shù)據(jù)，評(píng)估sac-TMT用于既往治療的EGFR突變晚期NSCLC患者（Presentation #LBA5, Proffered paper session: Presidential Symposium II）[12]III期OptiTROP-Breast02研究公布主要結(jié)果，評(píng)估sac-TMT用于既往治療的不可切除局部晚期或轉(zhuǎn)移性HR+/HER2-乳腺癌患者（Presentation #LBA23, Proffered paper session 1: Breast cancer, metastatic）[12]I/II期MK-2870-001研究公布療效與安全性數(shù)據(jù)，評(píng)估sac-TMT用于晚期或轉(zhuǎn)移性宮頸癌患者（Presentation #1168P, Poster session: Gynaecological cancers）[12]II期MK-2870-002/SKB264-II-06研究D隊(duì)列公布數(shù)據(jù)，評(píng)估sac-TMT聯(lián)合帕博利珠單抗用于轉(zhuǎn)移性去勢(shì)抵抗性前列腺癌患者（(Presentation #2421P, Poster session: Prostate cancer）[12]

更多將在ESMO會(huì)議上公布的關(guān)鍵摘要包括：

乳腺癌Sacituzumab tirumotecan (sac-TMT) vs investigator’s choice of chemotherapy (ICC) in previously treated locally advanced or metastatic hormone receptor-positive, HER2-negative (HR+/HER2-) breast cancer (BC): Results from the randomized, multi-center Phase 3 OptiTROP-Breast02 study. Y. Fan.??[12]Presentation #LBA23, Proffered paper session 1: Breast cancer, metastaticPatient-reported outcomes (PROs) with sacituzumab govitecan (SG) + pembrolizumab (pembro) vs chemotherapy (chemo) + pembro in patients (pts) with previously untreated PD-L1+ metastatic triple-negative breast cancer (mTNBC) in the Phase 3 ASCENT-04/KEYNOTE-D19 study. E. De Azambuja.[13]?Presentation #LBA22, Mini oral session: Breast cancer, metastatic

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泌尿系統(tǒng)腫瘤Perioperative (periop) enfortumab vedotin (EV) plus pembrolizumab (pembro) in participants (pts) with muscle-invasive bladder cancer (MIBC) who are cisplatin-ineligible: The Phase 3 KEYNOTE-905 study. C. Vulsteke.[5]Presentation #LBA2, Proffered paper session: Presidential Symposium ISacituzumab tirumotecan (sac-TMT) + pembrolizumab (pembro) in metastatic castration-resistant prostate cancer (mCRPC): Results from Phase 2 MK-2870-002/SKB264-II-06 study. X. Bian.[12]Presentation #2421P, Poster session: Prostate cancerFinal analysis of lenvatinib + pembrolizumab (L+P) vs sunitinib (S) in patients with advanced renal cell carcinoma (aRCC) with or without bone metastases in CLEAR. C. G. Porta.[7]Presentation #2603P, Poster session: Renal cancerBelzutifan for advanced clear cell renal cell carcinoma (ccRCC) after a PD-(L)1 inhibitor and ≥2 VEGFR-TKIs in LITESPARK-005. G. A. De Velasco Oria.Presentation #2607P, Poster session: Renal cancerEV-103 cohort K: Efficacy and safety of enfortumab vedotin (EV) with or without pembrolizumab (P) in cisplatin (cis)-ineligible pts with previously untreated locally advanced or metastatic urothelial cancer (la/mUC) with a median (m) follow-up (FU) of ≈3.5 y. T. Friedlander.[5]Presentation #3074P, Poster session: Urothelial cancerFirst-line pembrolizumab-based regimens for advanced clear cell renal cell carcinoma: KEYMAKER-U03 substudy 03A. C.S. Rodriguez.Presentation #LBA96, Proffered paper session 2: GU tumours, renal & urothelialBelzutifan plus lenvatinib for Chinese participants (pts) with previously treated advanced clear cell renal cell carcinoma (ccRCC): Updated results of cohort 1 of the LITESPARK-010 study. X. Sheng.[7]Presentation #2615P, Poster session: Renal cancer

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婦科腫瘤Pembrolizumab vs placebo plus weekly paclitaxel ± bevacizumab in platinum-resistant recurrent ovarian cancer: Results from the randomized double-blind Phase 3 ENGOT-ov65/KEYNOTE-B96 study. N. Colombo.[6]Presentation #LBA3, Proffered paper session: Presidential Symposium IRaludotatug deruxtecan (R-DXd) in patients with platinum-resistant ovarian cancer (PROC): Primary analysis of the Phase 2, dose-optimization part of the REJOICE-Ovarian01 study. I. L. Ray-Coquard??.[11]Presentation # LBA42, Proffered paper session: Gynaecological cancersEfficacy and safety of sacituzumab tirumotecan (sac-TMT) monotherapy in advanced/metastatic cervical cancer: Results from a Phase 1/2 study (MK-2870-001/KL264-01). Z. Yang.[12]Presentation #1168P, Poster session: Gynaecological cancersLenvatinib plus pembrolizumab (L + P) vs treatment of physician’s choice (TPC) for advanced endometrial cancer (EC): 5-year outcomes from Study 309/KEYNOTE-775. V. Makker.[7]Presentation #1119P, Poster session: Gynaecological cancersSacituzumab tirumotecan (sac-TMT) monotherapy in advanced/metastatic endometrial carcinoma (EC): Results from a Phase 1/2 study (MK-2870-001/KL264-01). K. Wang.[12]Presentation #1111P, Poster session: Gynaecological cancersTisotumab vedotin plus carboplatin or pembrolizumab in recurrent or metastatic cervical cancer: 5-year results from the innovaTV 205/GOG-3024/ENGOT-cx8 study. B. J. Monk.[6], [14]Presentation #1166P, Poster session: Gynaecological cancersPatient-reported outcomes (PROs) with 1L pembrolizumab (pembro) + chemotherapy (chemo) then maintenance pembro + olaparib (ola) in advanced BRCA1/2-nonmutated epithelial ovarian cancer (EOC): Phase 3 ENGOT-ov43/GOG-3036/KEYLYNK-001 Study. S. Topuz.[6]Presentation #1072P, Poster session: Gynaecological cancers

頭頸癌Neoadjuvant-adjuvant (neoadj-adj) pembrolizumab (pembro) plus standard-of-care (SOC) in resectable locally advanced head and neck squamous cell carcinoma (LA HNSCC): Participant-reported outcomes (PRO) in KEYNOTE-689. Y. Tao.Presentation #1330MO, Mini oral session: Head & neck cancer

肺癌Sacituzumab tirumotecan (sac-TMT) vs platinum-based chemotherapy in EGFR-mutated (EGFRm) non-small cell lung cancer (NSCLC) following progression on EGFR-TKIs: Results from the randomized, multi-center Phase 3 OptiTROP-Lung04 study. L. Zhang. [12]Presentation #LBA5, Proffered paper session: Presidential Symposium IIPerioperative pembrolizumab in early-stage non-small-cell lung cancer (NSCLC): 5-year follow-up from KEYNOTE-671. H. Wakelee.Presentation #LBA67, Mini oral session 2: Non-metastatic NSCLC10-year outcomes from clinical trials of pembrolizumab (pembro) monotherapy for locally advanced or metastatic non-small-cell lung cancer (NSCLC). E. B. Garon.??Presentation #3208P, Poster session: metastatic NSCLCIntracranial activity of ifinatamab deruxtecan (I-DXd) in patients (pts) with extensive-stage (ES) small cell lung cancer (SCLC) and baseline (BL) brain metastases (BM): Primary analysis of IDeate-Lung01. P. F. S. da Rocha.[11]Presentation #2760MO, Mini oral session 1: Non-metastatic NSCLCUpdated results from a Phase 1/2 study of gocatamig for small cell lung cancer (SCLC) and other neuroendocrine cancers. H. Beltran.[11]Presentation #2758MO, Mini oral session 1: Non-metastatic NSCLCSacituzumab tirumotecan (sac-TMT) + pembrolizumab (pembro) for treatment-na?ve advanced PD-L1-positive NSCLC: Results from the Phase 2 MK-2870-003/SKB264-II-04 Study. W. F. Fang.[12]Presentation #1949P, Poster session: NSCLC, metastaticSacituzumab tirumotecan (sac-TMT) in participants (pts) with previously treated, advanced KRAS-mutant NSCLC: Results from cohort 5d of the SKB264-II-08 Study. T. Zhou.[12]Presentation #1945P, Poster session: NSCLC, metastatic

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黑色素瘤和其他皮膚癌IO102-IO103 cancer vaccine plus pembrolizumab for first line (1L) advanced melanoma: Primary Phase 3 results (IOB-013/KN-D18). J. C. Hassel?.[15]Presentation #LBA53, Proffered paper session: Melanoma and other skin tumoursPembrolizumab versus placebo as adjuvant therapy for resected stage IIB or IIC melanoma: 5-year follow-up of the Phase 3 KEYNOTE-716 study. A. M. Eggermont.Presentation #1611P, Poster session: Melanoma and other skin tumours3-year survival with neoadjuvant-adjuvant pembrolizumab from SWOG S1801. V. K. Sondak.[16]Presentation #1601O, Proffered paper session: Melanoma and other skin tumoursECOB-ACRIN EA6174: STAMP: Surgically treated adjuvant Merkel cell carcinoma with pembrolizumab, a Phase III trial. J. M. Mehnert.[16]Presentation # LBA56, Proffered paper session: Melanoma and other skin tumours

多瘤種A Phase 2 study of participant (pt)-reported preference for pembrolizumab (pembro) administered subcutaneously (SC) or intravenously (IV). I. A. Casarini.Presentation #3145P, Poster session: General interestMK-1084 monotherapy in participants (pts) with KRAS G12C-mutated advanced solid tumors: Activity and safety in the Phase 1 KANDLELIT-001 study. M. Simonelli.[17]Presentation #926MO, Mini oral session: Developmental therapeuticsIO102-IO103 cancer vaccine plus pembrolizumab for first line (1L) treatment of advanced solid tumors: Final results of a Phase 2 basket trial. J. W. Riess.[15]Presentation #1557P, Poster session: Investigational immunotherapy

嗜鉻細(xì)胞瘤和副神經(jīng)節(jié)瘤LITESPARK-015: Belzutifan in advanced pheochromocytoma and paraganglioma. C. Jimenez.Presentation #1705O, Proffered paper session: NETs and endocrine tumoursBelzutifan for advanced pancreatic neuroendocrine tumors (panNETs): Results from cohort A2 of the Phase 2 LITESPARK-015 study. J. Capdevila.Presentation #1710MO, Mini oral session: NETs and endocrine tumours

胸腺Perioperative pembrolizumab for locally advanced thymic epithelial tumors. S. Park.Presentation #2967O, Proffered paper session: Mesothelioma and thymic tumours: Targeting and breaking through

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關(guān)于安斯泰來、輝瑞與默沙東的合作

? ? ?安斯泰來和Seagen與默沙東公司共同簽署了一項(xiàng)臨床合作協(xié)議，以評(píng)估安斯泰來和Seagen的注射用維恩妥尤單抗與默沙東的帕博利珠單抗聯(lián)合用藥治療此前未接受過治療的局部晚期或轉(zhuǎn)移性尿路上皮癌成人患者的療效。輝瑞公司于2023年12月14日完成了對(duì)于Seagen的收購(gòu)。

關(guān)于第一三共與默沙東的合作

? ? ? 2023年10月，第一三共與默沙東達(dá)成一項(xiàng)全球合作，除在日本第一三共保留獨(dú)家權(quán)利外，共同對(duì)patritumab deruxtecan (HER3-DXd)，ifinatamab deruxtecan (I-DXd) 和raludotatug deruxtecan (R-DXd)進(jìn)行臨床開發(fā)和商業(yè)推廣。第一三共將全權(quán)負(fù)責(zé)產(chǎn)品生產(chǎn)和供應(yīng)。2024年8月，雙方進(jìn)一步擴(kuò)大了全球共同開發(fā)與商業(yè)推廣合作，新增gocatamig（MK-6070/DS3280），除在日本默沙東保留獨(dú)家權(quán)利外，雙方將在全球范圍內(nèi)共同開發(fā)和推廣該藥物。默沙東將全權(quán)負(fù)責(zé)gocatamig的生產(chǎn)和供應(yīng)。?

關(guān)于衛(wèi)材與默沙東的戰(zhàn)略合作

? ? ? 2018 年 3 月，衛(wèi)材與默沙東（默沙東是美國(guó)新澤西州羅威市默克公司的公司商號(hào)）通過旗下子公司開展戰(zhàn)略合作，在全球范圍對(duì)侖伐替尼進(jìn)行共同臨床開發(fā)和商業(yè)推廣。根據(jù)協(xié)議，雙方將就侖伐替尼單藥或聯(lián)合默沙東 PD-1 抑制劑帕博利珠單抗進(jìn)行聯(lián)合臨床開發(fā)、生產(chǎn)和商業(yè)推廣。衛(wèi)材與默沙東正通過LEAP 系列臨床項(xiàng)目中涉及多個(gè)癌癥種類的多個(gè)臨床試驗(yàn)評(píng)估侖伐替尼和帕博利珠單抗的聯(lián)合使用。

關(guān)于默沙東早期癌癥臨床項(xiàng)目

? ? ? 癌癥的早期發(fā)現(xiàn)與治療有助于患者實(shí)現(xiàn)更大機(jī)會(huì)的長(zhǎng)生存。目前許多癌癥在疾病早期階段被認(rèn)為是可被治療以及可能實(shí)現(xiàn)治愈的?；趯?duì)帕博利珠單抗治療多種晚期癌癥的理解，默沙東正進(jìn)行約30項(xiàng)注冊(cè)研究，探索公司產(chǎn)品組合和在研管線用于多種早期癌癥的治療。?

關(guān)于默沙東

? ? ? 在默沙東（默沙東是美國(guó)新澤西州羅威市默克公司的公司商號(hào)），我們齊心協(xié)力追求共同的目標(biāo)：我們發(fā)揮前沿科學(xué)的力量，在全球范圍內(nèi)拯救生命、改善生活。130多年來，我們通過研發(fā)重要藥物和疫苗，為全人類帶來希望。我們致力成為頂尖的研究密集型生物制藥公司——當(dāng)下，我們正處于研發(fā)前線，推出創(chuàng)新解決方案，以推進(jìn)人類和動(dòng)物疾病的預(yù)防和治療。我們建立了一個(gè)多元、包容的全球員工體系，以負(fù)責(zé)的態(tài)度經(jīng)營(yíng)每一天，確保所有人、所有社區(qū)都能有一個(gè)安全、可持續(xù)和健康的未來。更多信息，請(qǐng)?jiān)L問www.msd.com，并在X（前身為Twitter）、LinkedIn和Youtube平臺(tái)關(guān)注我們。?

關(guān)于默沙東中國(guó)

? ? ? 中國(guó)是默沙東全球增長(zhǎng)戰(zhàn)略中至關(guān)重要的一部分。默沙東中國(guó)總部設(shè)在上海，同時(shí)在北京設(shè)有研發(fā)中心、在杭州、寧波和天津分別設(shè)有工廠，實(shí)現(xiàn)了研發(fā)、制造和商業(yè)運(yùn)營(yíng)三擎合一。我們?nèi)娜?，向中?guó)大眾提供高質(zhì)量的創(chuàng)新藥品、疫苗和服務(wù)，造福中國(guó)社會(huì)。更多信息，敬請(qǐng)?jiān)L問默沙東中國(guó)官網(wǎng)，或關(guān)注默沙東中國(guó)在微信上的官方社交媒體賬號(hào)。?

默沙東前瞻性聲明

? ? ? 默沙東公司全球總部位于美國(guó)新澤西州羅威市（下稱“公司”）。本新聞稿包含根據(jù)《1995年美國(guó)私人證券訴訟改革法案》之安全條款而做出的“前瞻性聲明”。本文內(nèi)容基于公司管理層當(dāng)前的看法和預(yù)期，并且受制于可能出現(xiàn)的重大風(fēng)險(xiǎn)和不確定因素。默沙東不保證在研產(chǎn)品能獲得所需的監(jiān)管部門批準(zhǔn)或取得商業(yè)成功。如果相關(guān)假設(shè)與現(xiàn)實(shí)有所出入、出現(xiàn)風(fēng)險(xiǎn)，或發(fā)生不確定情況，實(shí)際結(jié)果可與前瞻性聲明中的預(yù)期有實(shí)質(zhì)上的差異。

? ? ? 風(fēng)險(xiǎn)和不確定因素包括但不僅限于一般行業(yè)情況與競(jìng)爭(zhēng)、一般經(jīng)濟(jì)因素（包括利率與匯率浮動(dòng)）、近期發(fā)生的全球新型冠狀病毒疫情（COVID-19）、美國(guó)及其他國(guó)家制藥行業(yè)監(jiān)管以及醫(yī)療政策的影響、全球范圍內(nèi)控制醫(yī)療成本的趨勢(shì)、技術(shù)發(fā)展、競(jìng)爭(zhēng)對(duì)手獲得的新產(chǎn)品與專利、新產(chǎn)品開發(fā)固有的挑戰(zhàn)（包括獲得監(jiān)管部門批準(zhǔn)）、默沙東對(duì)未來市場(chǎng)形勢(shì)做出準(zhǔn)確預(yù)測(cè)的能力、生產(chǎn)上的困難或遲延、國(guó)際經(jīng)濟(jì)金融狀況不穩(wěn)定與主權(quán)風(fēng)險(xiǎn)、對(duì)默沙東專利和其它創(chuàng)新產(chǎn)品保護(hù)的有效性的依賴程度，以及公司面臨專利訴訟和/或監(jiān)管行動(dòng)的風(fēng)險(xiǎn)。

? ? ? 默沙東沒有義務(wù)就新信息、未來事件或其它原因?qū)θ魏吻罢靶月暶鬟M(jìn)行公開的更新。尚有其它因素可能導(dǎo)致實(shí)際結(jié)果與前瞻性聲明存在實(shí)質(zhì)性差異，請(qǐng)參見默沙東2024年報(bào)10-K報(bào)表以及公司在美國(guó)證券交易所備案的其它文件（可在美國(guó)證券交易所網(wǎng)站www.sec.gov上查閱）。