CLDN18.2靶向ADC 3期研究達到雙主要終點；雙靶點ADC 3期結果積極……

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CLDN18.2靶向ADC國際3期研究達到雙主要終點，延長胃癌患者PFS和OS 武田(Takeda)和信達生物（HK1801）(Innovent Biologics)公布了在研CLDN18.2靶向抗體偶聯藥物(ADC)arcotatug tavatecan治療晚期胃癌的國際性3期G-HOPE-001研究結果。研究同時達到無進展生存期(PFS)和總生存期(OS)兩項主要終點，顯著延長既往接受過多線...

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Dual-target ADC Phase 3 results are positive...","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"FFBC":1,"IHE":0.6,"ORR":1,"PFS":1,"NETL":0.6,"ADC":1,"FTXH":0.6,"ITT":1,"GMAB":1,"BMY":1},"content_text":"CLDN18.2靶向ADC國際3期研究達到雙主要終點，延長胃癌患者PFS和OS 武田(Takeda)和信達生物（HK1801）(Innovent Biologics)公布了在研CLDN18.2靶向抗體偶聯藥物(ADC)arcotatug tavatecan治療晚期胃癌的國際性3期G-HOPE-001研究結果。研究同時達到無進展生存期(PFS)和總生存期(OS)兩項主要終點，顯著延長既往接受過多線治療的CLDN18.2陽性晚期胃癌患者的生存期。 G-HOPE-001是一項國際性多中心、隨機、開放標籤3期研究，共納入464例既往接受過2至4線系統治療的CLDN18.2陽性、不可切除局部晚期或轉移性胃癌或胃食管交界部腺癌患者。受試者按1：1比例接受每3周一次、劑量為6mg/kg的arcotatug tavatecan，或研究者選擇的伊立替康、紫杉醇或曲氟尿苷/替匹嘧啶治療。最新分析顯示，arcotatug tavatecan組的中位總生存期達到10.2個月，對照組為6.9個月，死亡風險降低43%(HR=0.57，95%CI：0.45～0.73，P<0.0001)。經獨立影像學評估，兩組中位PFS分別為7.1個月和3.1個月(HR=0.45，95%CI：0.35～0.58)，經確認的客觀緩解率分別為37.4%和7.7%。 Arcotatug tavatecan是一款靶向緊密連接蛋白CLDN18.2的ADC，通過抗體將拓撲異構酶1抑制劑exatecan遞送至表達CLDN18.2的腫瘤細胞。該藥還採用Fc效應功能沉默設計，旨在降低抗體Fc段介導的非腫瘤組織毒性風險。CLDN18.2在正常胃黏膜組織中主要位於細胞間緊密連接區域，在部分胃癌等實體瘤中則異常暴露於腫瘤細胞表面，因此成為近年來胃癌靶向藥物開發的重要靶點。 EGFR/HER3雙靶點ADC3期結果積極，降低59%乳腺癌疾病進展或死亡風險百時美施貴寶（BMY）(Bristol Myers Squibb)與SystImmune宣佈，靶向表皮生長因子受體(EGFR)和人表皮生長因子受體3(HER3)的雙特異性ADC izalontamab brengitecan(iza-bren)治療激素受體陽性(HR+)、人表皮生長因子受體2(HER2)陰性晚期乳腺癌的3期PANKU-Breast01研究取得積極結果。研究達到PFS主要終點，使患者疾病進展或死亡風險降低59%。 PANKU-Breast01是一項隨機3期研究，共納入383例既往至少接受過一線化療後疾病進展的不可切除局部晚期、複發性或轉移性HR+/HER2陰性乳腺癌患者。其中190例患者接受iza-bren治療，193例接受化療。主要終點為盲態獨立中心審查(BICR)評估的PFS。 PFS中位隨訪時間為15.2個月時，iza-bren組的中位PFS達到8.2個月，對照組為4.0個月，疾病進展或死亡風險降低59%(HR=0.41，95%CI：0.33～0.53，P<0.0001)。此外，兩組經確認的客觀緩解率(cORR)分別為40.5%和20.2%，中位緩解持續時間分別為6.9個月和4.2個月。 Iza-bren是一款在研的潛在「First（FFBC）-in-class」雙特異性ADC，可同時靶向EGFR和HER3。這兩個受體均參與腫瘤細胞增殖和存活相關信號傳導。通過雙靶點結合，iza-bren能夠識別表達EGFR或HER3的腫瘤細胞，並在內化後釋放拓撲異構酶1抑制劑載荷，誘導腫瘤細胞死亡。該藥還被設計為能夠阻斷EGFR和HER3相關信號，進一步抑制腫瘤細胞增殖。FRα靶向ADC3期結果積極，卵巢癌患者疾病進展或死亡風險降低71% Genmab（GMAB）宣佈，在研抗體偶聯藥物rinatabart sesutecan(Rina-S)治療鉑耐藥卵巢癌的全球3期RAINFOL-02研究獲得積極頂線結果。研究達到PFS主要終點及OS關鍵次要終點，顯著降低患者的疾病進展或死亡風險。值得關注的是，在不同葉酸受體α(FRα)表達水平的患者中均觀察到相關獲益。 RAINFOL-02是一項全球性、多中心、隨機、開放標籤3期研究，共有584例鉑耐藥卵巢癌患者接受隨機分組，不限制FRα表達水平。受試者按1：1比例接受每3周一次、劑量為120mg/m 的Rina-S，或研究者選擇的紫杉醇、拓撲替康、聚乙二醇化脂質體多柔比星或吉西他濱治療。主要終點為研究者評估的PFS，關鍵次要終點包括OS和客觀緩解率(ORR)。結果顯示，在全部隨機患者組成的意向治療(ITT)人群中，與對照組相比，Rina-S使疾病進展或死亡風險降低71%(HR=0.29，95%CI：0.23～0.37，P<0.0001)，死亡風險降低57%(HR=0.43，95%CI：0.31～0.59，P<0.0001)。在預設的492例主要分析人群中，該藥使疾病進展或死亡風險降低67%(HR=0.33，95%CI：0.26～0.42)，死亡風險降低56%(HR=0.44，95%CI：0.31～0.63)，均達到統計學顯著性。 Rina-S是一款靶向FRα的ADC，由靶向抗體與拓撲異構酶1(TOPO1)抑制劑載荷組成，通過抗體識別腫瘤細胞表面的FRα，將細胞毒性藥物遞送至腫瘤細胞內發揮作用。[1]Takeda Announces Arcotatug Tavatecan(TAK-921)Demonstrated Statistically Significant and Clinically Meaningful Improvements in Overall Survival and Progression-Free Survival in Phase3Advanced Gastric Cancer Study.Retrieved October23,2026,from https://www.takeda.com/newsroom/newsreleases/2026/arcotatug-tavatecan-phase-3-study/[2]Izalontamab Brengitecan(Iza-Bren)Reduced Risk of Disease Progression or Death by59%versus Chemotherapy in Patients with Advanced HR+/HER2-Breast Cancer in Phase3PANKU-Breast01Study.Retrieved October23,2026,from https://news.bms.com/news/corporate-financial/2026/Izalontamab-Brengitecan-Iza-Bren-Reduced-Risk-of-Disease-Progression-or-Death-by-59-versus-Chemotherapy-in-Patients-with-Advanced-HRHER2--Breast-Cancer-in-Phase-3-PANKU-Breast01-Study/default.aspx [3]Genmab（GMAB） Announces Rinatabart Sesutecan(Rina-S )Demonstrates Statistically Significant Improvement in Progression-Free Survival and Overall Survival in Patients with Platinum-Resistant Ovarian Cancer.Retrieved October23,2026,from https://www.businesswire.com/news/home/20261023662606/en/Genmab（GMAB）-Announces-Rinatabart-Sesutecan-Rina-S-Demonstrates-Statistically-Significant-Improvement-in-Progression-Free-Survival-and-Overall-Survival-in-Patients-with-Platinum-Resistant-Ovarian-Cancer","kind":"highlight","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":false,"editions":null,"column":"","sentiment":"0","news_tag":"","news_rank":0,"isVideo":false,"video":null,"symbols":[],"gpt_button":1,"need_auth":false,"need_login_tip":false,"code":"91000000","status":"200"}}}