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中國(guo)蘇(su)州和(he)美國(guo)馬里蘭(lan)州羅(luo)克維爾市2022年(nian)6月(yue)8日 /美(mei)通社(she)/ -- 致力(li)于在腫瘤、乙肝(gan)及與(yu)衰老相關疾病等(deng)治療領域開(kai)發(fa)創新藥(yao)物的領先(xian)的生物醫(yi)藥(yao)企業——亞(ya)盛(sheng)醫(yi)藥(yao)(6855.HK)今日宣布,公司已在第58屆美(mei)國(guo)(guo)臨床腫瘤學會(ASCO)年會上,以壁報形式公布了Bcl-2抑制劑APG-2575治療復發(fa)/難治性(R/R)慢(man)性淋(lin)巴(ba)細胞白血(xue)病/小淋(lin)巴(ba)細胞淋(lin)巴(ba)瘤(CLL/SLL)患者的中國(guo)(guo)Ib/II期臨床試驗最新數據。
今年(nian)是亞盛醫(yi)藥(yao)連續(xu)第五(wu)年(nian)亮(liang)相ASCO年(nian)會(hui),此次公司共有(you)五(wu)個原研(yan)(yan)品種的(de)七項臨床研(yan)(yan)究入選(xuan)。其(qi)中(zhong),公司細胞凋亡管線重(zhong)要品種APG-2575在中(zhong)國(guo)R/R CLL/SLL患者中(zhong)的(de)臨床數(shu)據(ju)(ju)表(biao)現(xian)積(ji)極,客觀(guan)緩解(jie)率(ORR)達67.4%,且耐受良(liang)好,不良(liang)事件(jian)可控,在最高(gao)劑(ji)(ji)量800mg未觀(guan)察到劑(ji)(ji)量限(xian)制(zhi)毒(du)性(xing)(DLT),在每日劑(ji)(ji)量遞增(zeng)給(gei)藥(yao)方式下(xia)腫瘤溶解(jie)綜合征(TLS)風險極低。這(zhe)是Bcl-2抑制(zhi)劑(ji)(ji)在中(zhong)國(guo)R/R CLL/SLL患者中(zhong)的(de)首個較大樣本量的(de)研(yan)(yan)究報告。和國(guo)外同類(lei)藥(yao)物在國(guo)外類(lei)似患者人(ren)群中(zhong)的(de)數(shu)據(ju)(ju)相比(bi),有(you)效性(xing)相當,安(an)全性(xing)更(geng)好。亞盛醫(yi)藥(yao)將(jiang)在后續(xu)學術(shu)(shu)會(hui)議和學術(shu)(shu)期刊上發(fa)布該研(yan)(yan)究更(geng)詳細的(de)數(shu)據(ju)(ju)。
該(gai)項臨(lin)床研究(jiu)的主要研究(jiu)者、江蘇省人(ren)民醫院血液科主任李建勇教(jiao)授(shou)表示(shi):"APG-2575是(shi)一種選擇(ze)性Bcl-2抑制劑,能誘導細(xi)胞凋(diao)亡,抑制細(xi)胞生長。在此項Ib/II期臨(lin)床研究(jiu)中,APG-2575單藥治(zhi)療(liao)初(chu)步(bu)顯示(shi)出對R/R CLL/SLL患(huan)者的抗(kang)腫瘤活性以及(ji)良(liang)好的安全性,其(qi)每日劑量(liang)遞增(zeng)方式對患(huan)者更為(wei)友好。我們(men)期待進(jin)一步(bu)評估APG-2575單藥或聯合治(zhi)療(liao)在R/R CLL/SLL患(huan)者的療(liao)效。"
"APG-2575是首個(ge)在(zai)中(zhong)國(guo)(guo)進(jin)(jin)入臨床階段(duan)(duan)的、本土研發的Bcl-2抑(yi)(yi)制劑(ji),也是全(quan)球(qiu)(qiu)(qiu)第(di)二個(ge)、國(guo)(guo)內首個(ge)看到(dao)明確療(liao)(liao)效、并進(jin)(jin)入關鍵(jian)注冊(ce)臨床階段(duan)(duan)的Bcl-2抑(yi)(yi)制劑(ji)。此(ci)次(ci)公布的數據進(jin)(jin)一(yi)步證(zheng)明APG-2575或可為R/R CLL/SLL患(huan)(huan)者(zhe)(zhe)提供(gong)一(yi)種(zhong)療(liao)(liao)效確切(qie)、安全(quan)性更好、且給(gei)藥(yao)方案(an)更便捷友(you)好的可替(ti)代治療(liao)(liao)方案(an),我(wo)們(men)期待盡快將APG-2575推(tui)向上(shang)(shang)市,早(zao)日惠(hui)及(ji)患(huan)(huan)者(zhe)(zhe);此(ci)外,我(wo)們(men)也正積極探(tan)索該(gai)品種(zhong)在(zai)晚(wan)期實(shi)體(ti)瘤中(zhong)的單藥(yao)或聯合治療(liao)(liao)潛(qian)力,"亞盛醫(yi)(yi)藥(yao)首席(xi)醫(yi)(yi)學官翟一(yi)帆表示:"今(jin)年,我(wo)們(men)在(zai)ASCO年會上(shang)(shang)展示了多個(ge)品種(zhong)的多項臨床進(jin)(jin)展。對此(ci)我(wo)感到(dao)非常自豪,因為這(zhe)是亞盛醫(yi)(yi)藥(yao)全(quan)球(qiu)(qiu)(qiu)創新能(neng)力的體(ti)現。未來,我(wo)們(men)將繼續秉(bing)持(chi)初(chu)心,堅守‘解決中(zhong)國(guo)(guo)乃至(zhi)全(quan)球(qiu)(qiu)(qiu)患(huan)(huan)者(zhe)(zhe)尚未滿足的臨床需求'這(zhe)一(yi)使命,加快臨床開(kai)發,早(zao)日惠(hui)及(ji)全(quan)球(qiu)(qiu)(qiu)患(huan)(huan)者(zhe)(zhe)。"
APG-2575在此次ASCO年會上展示的核心要點如下:
A phase Ib/II study of lisaftoclax (APG-2575), a novel BCL-2 inhibitor (BCL-2i), in patients (pts) with relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (R/R CLL/SLL).
新型BCL-2抑制劑(BCL-2i)APG-2575治療復發/難治性慢性淋巴細胞白血病/小淋巴細胞淋巴瘤(R/R CLL/SLL)患者的Ib/II期臨床研究
摘要編號:#7543
附:亞盛醫藥在(zai)本屆ASCO年會展示的(de)包括APG-2575在(zai)內5個品種的(de)多項最新(xin)臨床(chuang)試(shi)驗進展包括:
產品 |
摘要 |
編號 |
形式 |
奧(ao)雷巴替尼(HQP1351) |
Promising antitumor activity of olverembatinib (HQP1351) in patients (pts) with tyrosine kinase inhibitor- (TKI-) resistant succinate dehydrogenase- (SDH-) deficient gastrointestinal stromal tumor (GIST). 奧雷(lei)巴替尼(HQP1351)在(zai)酪氨酸(suan)激酶抑制劑(TKI)耐藥的琥珀酸脫氫酶缺陷型胃(wei)腸間質瘤(SDH-deficient GIST)患者中顯(xian)示良好的抗(kang)腫(zhong)瘤活(huo)性 |
#11513 |
壁報討論 |
APG-2575 (Lisaftoclax) |
A phase Ib/II study of lisaftoclax (APG-2575), a novel BCL-2 inhibitor (BCL-2i), in patients (pts) with relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (R/R CLL/SLL). 新型BCL-2抑(yi)制(zhi)劑(BCL-2i)APG-2575治療復發/難治性(xing)慢性(xing)淋巴(ba)細胞(bao)白血病(bing)/小淋巴(ba)細胞淋巴(ba)瘤(R/R CLL/SLL)患者的Ib/II期臨(lin)床研究 |
#7543 |
壁報(bao)展示 |
Phase Ib/II study of BCL-2 inhibitor lisaftoclax (APG-2575) safety and tolerability when administered alone or combined with a cyclin-dependent kinase 4/6 (CDK4/6) inhibitor in patients with estrogen receptor-positive (ER?) breast cancer or advanced solid tumors. 一(yi)項(xiang)旨在評估(gu)BCL-2抑制劑APG-2575單藥或聯合周期蛋白依賴性激酶4/6(CDK4/6)抑制(zhi)劑治療雌激素受體陽(yang)性(xing)(ER+)乳腺癌和晚期實體瘤患者的安(an)全性和耐受性的Ib/II期臨床(chuang)研究 |
#TPS1122 |
壁報展示 |
|
APG-115 (Alrizomadlin) |
Newly updated activity results of alrizomadlin (APG-115), a novel MDM2/p53 inhibitor, plus pembrolizumab: Phase 2 study in adults and children with various solid tumors. 新型MDM2-p53抑(yi)制劑APG-115聯合帕(pa)博利(li)珠(zhu)單抗治療成人(ren)及(ji)兒(er)童實體瘤患者的(de)最新II期臨(lin)床數據 |
#9517 |
壁報討論(lun) |
APG-2449 |
First-in-human phase I results of APG-2449, a novel FAK and third-generation ALK/ ROS1 tyrosine kinase inhibitor (TKI), in patients (pts) with second-generation TKI-resistant ALK/ROS1 non-small-cell lung cancer (NSCLC) or mesothelioma. 新型FAK抑制劑和(he)第三代(dai)ALK/ ROS1酪氨酸激(ji)酶抑制劑(TKI)APG-2449治(zhi)療對(dui)二代(dai)TKI耐藥的ALK/ROS1+ 非小細(xi)胞肺癌(NSCLC)和惡性間皮瘤患者的首次人體I期(qi)試驗數(shu)據(ju) |
#9071 |
壁報展(zhan)示(shi) |
APG-1252 (Pelcitoclax) |
Updated study results of pelcitoclax (APG-1252) in combination with osimertinib in patients (pts) with EGFR-mutant non-small-cell lung cancer (NSCLC). APG-1252聯合奧希(xi)替尼治療(liao)攜帶(dai)EGFR突變(bian)的非小細胞肺癌(NSCLC)患者的最新臨(lin)床數(shu)據 |
#9116 |
壁報展示 |
First-in-human study of pelcitoclax (APG-1252) in combination with paclitaxel in patients (pts) with relapsed/refractory small-cell lung cancer (R/R SCLC). APG-1252聯(lian)合紫杉(shan)醇治療復發/難(nan)治性小細胞肺癌(ai)(R/R SCLC)患者(zhe)的首次人體(ti)試驗 |
e20612 |
在線發表 |