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喜讯!三阴乳腺癌迎来首个靶向药物!Tecentriq+Abraxane获批一线疗法

医药魔方 医药魔方 来源:医药魔方
2019-03-10
乳腺癌
原文

3月9日,Genentech宣布FDA加速批准Tecentriq联合Abraxane(白蛋白紫杉醇)一线治疗PD-L1阳性的不可手术切除的局部晚期或转移性三阴乳腺癌。FDA此次批准是基于IMpassion130研究的PFS数据,Genentech之后还要继续开展验证性临床研究,以支持Tecentriq在该适应症上获得完全批准。


三阴乳腺癌(Triple-Negative Breast Cancer,TNBC)是指雌激素受体(ER)、孕激素受体(PR)及人表皮生长因子受体2(HER-2)均为阴性的乳腺癌类型,占所有乳腺癌病理类型的10%~20%,多发于绝经前女性。三阴乳腺癌是最凶险的一种乳腺癌,侵袭性强,易转移,预后极差,患者确诊后的生存期通常不超过20个月,5年生存率不足15%。


三阴乳腺癌一般按照预后较差的乳腺癌进行常规治疗,标准疗法是术后使用含有蒽环类或紫杉醇类的新辅助化疗。由于TNBC患者的雌激素受体、孕激素受体或HER2受体存在多种亚型,即便是同一治疗方案,不同患者的应答水平也有很大差异。美国此前未批准任何用于治疗TNBC的靶向药物。


IMpassion130研究是多中心随机双盲Ⅲ期临床研究,评估了Atezolizumab联合白蛋白紫杉醇治疗此前未接受过全身治疗的局部晚期或转移性三阴乳腺癌的疗效、安全性和药动学,入组902例患者,主要研究终点是RECIST 1.1标准评价的PFS和OS,在所有意向治疗人群和PD-L1阳性人群中进行分析。


结果显示,Tecentriq+Abraxane相比单独使用Abraxane可使未接受系统治疗的PD-L1+晚期或转移性三阴乳腺癌患者的疾病恶化或死亡的风险降低40%,PFS分别为7.4和4.8个月。


两个药物联用的安全性数据与单独使用的安全性数据一致,未发现新的不良反应信号。最常见的(≥2%)的3-4级严重不良反应包括白细胞计数降低、手脚刺痛或麻木,中性粒细胞计数降低,疲倦、红细胞计数降低、血钾水平降低、肺炎、AST增高。


Tecentriq的2018年全球销售额是7.72亿瑞士法郎,三阴乳腺癌是其在膀胱癌和肺癌之后获批的第3大适应症,也是PD-1/PD-L1免疫治疗药物首次获批用于乳腺癌。


机器翻译

On March 9, Genentech announced that the FDA has accelerated the approval of Tecentriq in combination with Abraxane (albuminol) for the first-line treatment of PD-L1-positive unresectable locally advanced or metastatic triple-negative breast cancer. The FDA approval is based on the IMpassion130 study. After the PFS data, Genentech will continue to conduct confirmatory clinical studies to support Tecentriq's complete approval for this indication.

Triple-Negative Breast Cancer (TNBC) refers to females. Hormone receptor (ER). Progesterone receptor (PR) and human epidermal growth factor receptor 2 (HER-2) are negative breast cancer types, accounting for 10% to 20% of all breast cancer pathological types, mostly in Premenopausal women. Sanyin breast cancer is the most dangerous type of breast cancer, it is aggressive, easy to metastasize, and the prognosis is very poor. The survival time after diagnosis is usually less than 20 months, and the 5-year survival rate is less than 15%. /p>

Three-negative breast cancer is generally treated according to poor prognosis of breast cancer. Standard therapy is postoperative use of neoadjuvant chemotherapy with anthracyclines or paclitaxel. Because of estrogen receptors in patients with TNBC. Hormone receptor or HER2 receptor In a variety of subtypes, even in the same treatment regimen, the response levels of different patients vary widely. The United States has not previously approved any targeted drugs for the treatment of TNBC.

IMpassion130 study is a multicenter random double A blind phase III clinical trial evaluated the efficacy of Atezolizumab in combination with paclitaxel in the treatment of locally advanced or metastatic triple-negative breast cancer that had not previously received systemic therapy. Safety and pharmacokinetics, enrolled in 902 patients, the primary end point was The PFS and OS evaluated by the RECIST 1.1 criteria were analyzed in all intention-to-treat populations and PD-L1 positive populations.

The results showed that Tecentriq+Abraxane could not receive systemic treatment of PD compared to Abraxane alone. -L1+ patients with advanced or metastatic triple-negative breast cancer have a 40% lower risk of disease progression or death, with PFS of 7.4 and 4.8 months, respectively.

Safety data for the combination of the two drugs and use alone The safety data was consistent and no new adverse reaction signals were found. The most common (≥2%) serious grade 3-4 adverse reactions included decreased white blood cell counts. Stinging or numbness of hands and feet, decreased neutrophil count, and fatigue. Decreased red blood cell count. Blood potassium level decreased. Pneumonia. AST increased.

Tecentriq's global sales in 2018 was 772 million Swiss francs, and triple-negative breast cancer was approved after bladder and lung cancer. 3 major indications, also the first PD-1/PD-L1 immunotherapy drugs approved for breast cancer.

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