在没有治疗的患者中,客观反应率(“ ORR”)为62.1%,疾病控制率(“ DCR”)为92.0%,中位反应持续时间为12.5个月,如一个独立审查委员会评估。中值无进展生存期(“ PFS”)为13.7个月,中间生存期(“ OS”)未达到20.8个月的中位随访。在先前治疗的患者中,ORR为39.2%,DCR为92.4%,中位数为11.1个月,如独立审查委员会的评估。中位PFS为11.0个月,中位OS不成熟,中位随访时间为12.5个月。反应发生在未接受治疗和先前治疗的患者中的早期(应答1.4-1.6个月)。安全性是可以忍受的,没有观察到新的安全信号。The most common drug-related treatment-emergent adverse events of Grade 3 or above (5% or more of patients) were abnormal hepatic function (16.9%), increased alanine aminotransferase (14.5%), increased aspartate aminotransferase (12.0%), peripheral oedema (6.0%) and increased gamma-glutamyltransferase (6.0%).
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