康方生物PD-1获FDA突破性疗法资格,三线治疗转移性鼻咽癌

2021-04-04 秘丛丛 亿欧

2020年9月,康方生物宣布派安普利单抗三线治疗转移性鼻咽癌的注册性临床试验达到了由独立影像评估的客观缓解率(ORR)主要终点。

2020年9月,康方生物宣布派安普利单抗三线治疗转移性鼻咽癌的注册性临床试验达到了由独立影像评估的客观缓解率(ORR)主要终点。

3月30日,康方生物宣布FDA授予派安普利单抗突破性疗法资格,用于三线治疗转移性鼻咽癌。

2020年9月,康方生物宣布派安普利单抗三线治疗转移性鼻咽癌的注册性临床试验达到了由独立影像评估的客观缓解率(ORR)主要终点,在既往经过多线治疗后的鼻咽癌患者中,展示了良好的临床疗效和安全性,将会向NMPA进行新药上市申请前沟通。

2020年5月,康方生物曾向NMPA提交了派安普利单抗治疗至少经过二线系统化疗复发或难治性经典型霍奇金淋巴瘤(r/rcHL)的新药上市申请。派安普利单抗拟开发的主要适应症包括肝癌、胃癌、肺癌、霍奇金淋巴瘤、鼻咽癌等疾病。

派安普利单抗由康方生物与正大天晴共同开发及商业化,其 Fc 受体和补体介导效用功能通过 Fc 区域突变而完全去除,同时与国外已上市 PD-1 抗体相比抗原结合解离速率较慢,因而具有更有效地阻断 PD-1 通路的活性,并维持更强的 T 细胞抗肿瘤活性。

鼻咽癌是一种发生于鼻咽部粘膜上皮的恶性肿瘤,多发生于鼻咽顶壁及侧壁。据统计,鼻咽癌影响全球约13万患者,以华南、东南亚和北非地区的患病率最高。超过70%的患者在确诊时已为局部晚期疾病,远处转移是患者复发和死亡的主要原因。

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