康宁杰瑞制药-B(09966.HK)将于WCLC 2020展示KN046治疗晚期NSCLC患者临床数据以及KN046治疗罕见胸部肿瘤患者初步结果摘要
格隆汇 1 月 13日丨康宁杰瑞制药-B(09966.HK)发布公告，有关(i)KN046(一种重组人源化PD-L1/CTLA-4双特异性抗体)治疗晚期NSCLC患者的II期临床研究的临床数据及(ii)KN046治疗罕见胸部肿瘤患者的I期临床研究的初步安全性及疗效结果的摘要已获准于即将举行的2020年世界肺癌大会(“WCLC 2020”)上展示。WCLC 2020为汇聚全世界肺癌及胸部肿瘤学领域临床医生、研究人员及科学家的最大国际盛会。WCLC 2020将于2021年1月28日至2021年1月31日举行。两项研究的临床数据将分别以海报及口头报告形式发布。
KN046-201为一项II期、开放、多中心临床研究，旨在评估KN046治疗晚期 NSCLC受试者的疗效、安全性及耐受性。共招募64例既往接受过NSCLC一线系统性治疗的患者。此外，KN046-AUS-001为于澳大利亚进行的I期临床研究。其中入组五例罕见胸部肿瘤患者，其中包括四例胸腺上皮肿瘤患者(两例胸腺癌患者(IV期)、两例胸腺瘤患者(IV期))及一例胸膜间皮瘤患者(肉瘤样变，IIIB期)。中位治疗时间为22.7周(范围：16至48周)。
公告表示，KN046是集团自主研发的全球首创PD-L1/CTLA-4双特异性抗体。KN046同时靶向两个临床验证的免疫检查点，PD-L1及CTLA-4。目前，KN046在澳大利亚和中国已开展覆盖十多种肿瘤(包括NSCLC、三阴乳腺癌、食管鳞癌、肝细胞癌及胰腺癌)的约20项不同阶段临床试验。该等临床试验结果初步显示出KN046具有良好的安全性和有效性。基于在中国及澳大利亚取得的临床试验结果，美国食品药品监督管理局已批准集团于美国直接进入KN046的II期临床试验。目前，旨在评估KN046联合含铂化疗对局部晚期不可切除或转移性鳞状NSCLC患者的疗效及安全性的III期临床试验已在中国启动。 KN046的临床前及临床试验结果表明可显著减少对人体外周系统可能产生的毒副作用。公司认为，KN046有望成为突破性肿瘤免疫特效药。
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