翰森制药(03692.HK)将在2021 ASCO年会发布阿美乐®一线治疗EGFR突变NSCLC的III期研究结果
格隆汇5月20日丨翰森制药(03692.HK)宣布，由公司附属公司江苏豪森药业集团有限公司开发的1.1类创新药阿美乐®(甲磺酸阿美替尼片，HS-10296)一线治疗具有表皮生长因子受体(“EGFR”)敏感突变阳性局部晚期或转移性非小细胞肺癌(“NSCLC”)III期临床研究(“AENEAS研究”)达到主要研究终点。具体研究结果将于6月4日在2021年美国临床肿瘤学会(ASCO)年会上以壁报讨论形式展示(壁报摘要编号9013)。
AENEAS研究显示，与吉非替尼相比，使用阿美乐作为一线治疗的患者，无进展生存期(“PFS”)显著延长(中位PFS 19.3个月 vs 9.9个月，HR 0.46, p-value<0.0001)，持续缓解时间(“DoR”)也显著延长(中位DoR 18.1个月 vs 8.3个月，HR 0.38, p-value <0.0001)，总生存期(“OS”)数据目前尚未成熟。
AENEAS研究数据显示，尽管阿美乐组用药时间显著延长(中位用药时间463天vs 254天)，其药物相关的皮疹、腹泻、AST/ALT升高及药物相关的严重不良反应(SAEs)发生率更低(SAEs：阿美替尼4.2% vs 吉非替尼11.2%)。
AENEAS研究结论显示，与吉非替尼相比，阿美乐用于一线治疗EGFR突变阳性局晚期或转移性NSCLC，可显著延长患者PFS及DoR，并具有更好的安全性，有潜力成为该类患者新的治疗选择。公司已与EQRx, INC.合作，拓展阿美乐在大中华区以外市场。
公告显示，AENEAS研究是一项随机双盲对照的多中心三期临床研究，研究阿美乐对比吉非替尼作为一线针对EGFR突变阳性局部晚期或转移性非小细胞肺癌患者的治疗。
研究的主要终点是PFS，次要终点包括OS，客观缓解率(ORR)和DoR以及安全性。总计429例受试者在53家中国中心被招募，并按照1:1比例随机接受阿美乐(一日一次110mg)或者吉非替尼(一日一次，250mg)治疗。
而阿美乐是一种新型的，不可逆的表皮生长因子受体酪氨酸激酶抑制剂(“EGFRTKI”)，具有良好的药学特性可以选择性的抑制EGFR敏感和耐受突变。阿美乐每日治疗剂量为110毫克的片剂，已经被NMPA批准作为用于既往经EGFR TKI治疗时或治疗后出现疾病进展的，存在EGFR T790M突变阳性的局部晚期或转移性NSCLC患者的药品。
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