百济神州(06160.HK)在AACR 2021年年会公布Sitravatinib联合百泽安®临床数据
格隆汇 4 月 12日丨百济神州(06160.HK)于2021年4月11日(美国东部时间)在美国癌症研究协会(AACR)2021年年会上的两项口头报告中公布了其抗PD-1抗体百泽安® (替雷利珠单抗)联合与Mirati Therapeutics, Inc. 合作开发的在研选择性激酶抑制剂sitravatinib的临床数据。在年会上公布的数据来自一项1b期临床试验 (NCT03666143)的两个伫列，分别用于治疗PD-1/PD-L1疗法难治性或耐药性的不可切除或转移性黑色素瘤患者以及用于治疗晚期铂类耐药卵巢癌(PROC)患者。
百济神州先前与Mirati Therapeutics, Inc. 达成独家合作和授权协定，在亚洲(不包括日本)、澳大利亚和纽西兰共同开发、生产和商业化sitravatinib。
百济神州肿瘤免疫学首席医学官贲勇医学博士表示：“从今天公布的数据来看，我们认为sitravatinib联合百泽安®有望为晚期实体瘤患者提供临床益处，并支持我们在正在开展的临床试验中进一步评估这项组合用药。此外，我们很兴奋地在PD-1/ PD-L1疗法难治性或耐药性黑色素瘤患者中观察到了初步抗肿瘤活性。我们将继续对患者进行随访并完成试验的全部患者入组，也期待同时不断加深对该组合用药的认知，为世界各地的患者提供一款新型抗击癌症的疗法。”
这项开放性、多中心的1b期临床试验旨在评估sitravatinib联合百泽安®针对晚期实体瘤患者的安全性╱耐受性和初步抗肿瘤活性。试验的主要终点为该项组合用药的安全性╱耐受性；关键次要终点包括经研究者基于实体瘤疗效评价标准(RECIST 1.1)评估的客观缓解率(ORR)、疾病控制率(DCR)和无进展生存期 (PFS)。此外，该试验也对总生存期(OS)进行评估。
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