第二代靶向抗癌药Vizimpro获美国FDA批准，EGFR突变肺癌一线治疗新选择。
2018年9月28日，美国FDA批准新型激酶抑制剂Dacomitinib（商品名：VIZIMPRO，中文译名：，辉瑞药品），一线治疗EGFR外显子19缺失或外显子21 L858R置换突变的转移性非小细胞肺癌患者。
相比吉非替尼，Dacomitinib将患者死亡或疾病进展的风险降低了40%，下面看试验数据： Dacomitinib的疗效和安全性是在ARCHER 1050试验中确定。这是一项随机、多中心的国际性开放研究。试验纳入452名未接受治疗的转移性非小细胞肺癌患者，这些患者都有EGFR外显子19缺失或外显子21 L858R置换突变，他们被随机分为两组，一组接受Dacomitinib治疗，一组接受吉非替尼治疗。
结果显示，与吉非替尼相比，Dacomitinib显著延长了患者的疾病无进展生存期。Dacomitinib组的中位无进展生存期为14.7个月，而吉非替尼组为9.2个月。另外，Dacomitinib组的疗效持续时间更长，为14.8个月，而吉非替尼组只有8.3个月。 Dacomitinib组最常见的副作用包括腹泻、皮疹、甲沟炎、口腔炎、食欲减退、皮肤干燥等。
该试验的首席研究员、香港中文大学临床肿瘤科主席Tony Mok说道：“EGFR突变非小细胞肺癌十分常见，尤其是在亚洲人群中。ARCHER 1050试验的结果表明，可以考虑将Dacomitinib作为EGFR外显子19缺失或外显子21 L858R置换突变患者的一线治疗方案。”
完整说明书附件：http://labeling.pfizer.com/ShowLabeling.aspx?id=11019
U.S. FDA Approves VIZIMPRO® (dacomitinib) for the First-Line Treatment of Patients with EGFR-Mutated Metastatic Non-Small Cell Lung Cancer
U.S. Food and Drug Administration (FDA) has approved VIZIMPRO [vih-ZIM-pro] (dacomitinib), a kinase inhibitor for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test。
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"Improving outcomes for patients is the central focus of why we develop and deliver new medicines. VIZIMPRO is yet another example of Pfizer’s commitment to providing more options in lung cancer where there is great unmet need," said Andy Schmeltz, Global President, Pfizer Oncology. "With today’s approval, Pfizer has medicines that target three unique lung cancer biomarkers, marking real progress for patients which has been achieved through a diverse and persistent drug development approach."
The safety and efficacy of VIZIMPRO was demonstrated in ARCHER 1050, a randomized, multicenter, multinational, open-label study. Patients were required to have unresectable, metastatic NSCLC with no prior therapy for metastatic disease or recurrent disease with a minimum of 12 months disease-free after completion of systemic therapy; an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; EGFR exon 19 deletion or exon 21 L858R substitution mutations. A total of 452 patients were randomized 1:1 to VIZIMPRO (n=227) or gefitinib (n=225). The primary endpoint was progression-free survival (PFS) as determined by blinded Independent Radiologic Central (IRC) review, and additional efficacy outcomes included overall response rate (ORR), duration of response (DoR) and overall survival (OS). A statistically significant improvement in PFS as determined by the IRC was demonstrated for patients randomized to VIZIMPRO compared with gefitinib (HR = 0.59 [95% CI: 0.47, 0.74], p <0.0001). Median PFS in the VIZIMPRO group was 14.7 m |
