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亞盛醫藥-B(06855.HK)耐立克、APG-2575、APG-115的五項研究進展將在美國血液學會年會展示,其中四項獲口頭報吿
格隆匯 11-03 23:01

格隆匯11月3日丨亞盛醫藥-B(06855.HK)公吿,公司共有3個在研新藥(耐立克、APG-2575、APG-115)的五項臨牀研究入選第64屆美國血液學會(AmericanSociety of Hematology,ASH)年會展示,其中4項獲口頭報吿。其中,公司原創I類新藥耐立克共有三項臨牀進展獲選口頭報吿。這是該品種的臨牀進展連續第五年入選ASH年會口頭報吿,充分體現國際血液學界對其療效和安全性的認可。同時,公司重要品種Bcl-2選擇性抑制劑APG-2575單藥或聯合治療初治、復發或難治(R/R)慢性淋巴細胞白血病╱小淋巴細胞淋巴瘤(CLL/SLL)患者的全球II期臨牀研究初步數據也獲口頭報吿。此為APG-2575聯合布魯頓氏酪氨酸激酶抑制劑(BTKi)acalabrutinib或利妥昔單抗治療R/R CLL/SLL患者的首次數據公佈。

在耐立克入選2022 ASH年會口頭報吿的臨牀進展中,該品種在美國慢性髓細胞白血病(CML)和費城染色體陽性急性淋巴細胞白血病(Ph+ ALL)患者中的有效性和安全性數據為亞盛醫藥首次公佈,且一經公佈即入選口頭報吿。數據顯示,耐立克在難治性CML和Ph+ ALL患者中的有效性和耐受性良好,即使在ponatinib或asciminib耐藥的患者中,亦顯現出很強的療效。這表明耐立克有望成為全球首個能有效克服ponatinib或asciminib耐藥的新一代BCR-ABL抑制劑。

此外,另外兩項入選口頭報吿的研究分別為該品種治療T315I突變耐藥CML患者的關鍵II期註冊臨牀研究的最新數據,和其用於中國CML耐藥患者的5年長期隨訪數據(I期臨牀研究),進一步驗證安全性和有效性。

APG-2575在此次ASH年會口頭報吿的數據體現了該品種在R/R CLL/SLL患者中強勁的單藥和聯合治療潛力。數據顯示:APG-2575聯合acalabrutinib治療R/RCLL/SLL的客觀緩解率(ORR)達98%;APG-2575聯合利妥昔單抗治療的ORR達87%。此外,單藥治療的研究結果和前期臨牀研究結果相似,再次展現了APG-2575優秀的療效和安全性;而聯合治療的研究,特別是和acalabrutinib的聯合治療的研究結果,顯示了超高的有效率。同時在腫瘤溶解綜合徵(TLS)的發生率和血液學不良事件等方面,聯合治療也保持了與APG-2575單藥治療相當的出色安全性。

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