中國生物製藥(01177.HK):TQB2102"HER2雙抗ADC"I期研究數據在2025年ASCO年會公佈
格隆匯5月27日丨中國生物製藥(01177.HK)宣佈,集團已在2025年美國臨牀腫瘤學會(ASCO)年會公佈了TQB2102「HER2雙特異性抗體偶聯藥物(ADC)」的首次人體I期臨牀研究初步數據。
截止2024年10月1日,該試驗共納入181例經治無標準治療方案的晚期實體瘤患者,包括HER2陽性和HER2低表達。研究結果顯示,在有效性方面,6mg/kg及以上劑量組中,HER2陽性乳腺癌客觀緩解率(ORR)爲51.3%,HER2低表達乳腺癌ORR爲51.5%,HER2高表達(HER2免疫組化3+)結直腸癌ORR爲34.8%,HER2陽性胃或胃食管結合部腺癌ORR爲70%。其中,HER2陽性乳腺癌伴腦轉移亞組ORR爲70%,1例顱內病竈完全緩解;31%的乳腺癌受試者在T-DM1/DS-8201耐藥後使用TQB2102治療仍有效。
在安全性方面,總人羣中≥3級不良事件(AE)主要爲中性粒細胞減少(21.7%)、白細胞計數降低(10.6%)、貧血(8.9%)、血小板計數降低(6.1%)等。特別值得關注的是,僅出現1例(0.55%) 2級間質性肺病(ILD),發生率遠低於同類藥物DS-8201 (發生率>10%)。
目前,全球尚無雙抗ADC藥物獲批上市。TQB2102在多個晚期惡性腫瘤中展現出顯着的臨牀獲益,且ILD發生率低,實現了療效和安全性的有效平衡。目前,TQB2102正在開展III期臨牀試驗,有望重塑HER2 ADC治療格局。
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