FDA批准第3个PD-L1抗体Durvalumab(商品名 Imfinzi）上市，治疗晚期或转移性尿路上皮癌患者。这些患者在先前的铂类化疗中或化疗后病情依旧出现进展，或在接受辅助或新辅助铂类化疗（neoadjuvant or adjuvant treatment with platinum-containing chemotherapy）的12个月内疾病出现进展。
商品名称：Imfinzi
通用名称：durvalumab
剂型：注射溶液剂
批准日期：2017年5月
适应证：
尿路上皮癌
Imfinzi（durvalumab）是针对程序性死亡配体-1（PD-L1）的研究性人单克隆抗体。PD-L1表达使得肿瘤能够通过与细胞毒性T淋巴细胞上的PD-1结合而逃避免疫系统的检测。Durvalumab阻断PD-L1与T细胞上的PD-1和CD80的相互作用，抵抗肿瘤的免疫逃避手段并激活患者的免疫系统来攻击癌症。Durvalumab在2016年获得PD-L1阳性不能手术或转移性UC患者的FDA突破性治疗指定，并于2015年通过快速通道指定治疗PD-L1阳性转移性头颈鳞状细胞癌患者。
用法与用量
推荐剂量为：每公斤体重10毫克，60分钟静脉点滴，每2周一次，直到疾病恶化或发生不可接受的毒副作用。
包装规格
单剂量小瓶
500mg/10mL

120mg/2.4mL

生产商：阿斯利康制药

Durvalumab (Imfinzi)
Imfinzi Gets Accelerated Approval for Urothelial Carcinoma
The Food and Drug Administration (FDA) has approved Imfinzi (durvalumab; AstraZeneca) for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. The indication is approved under accelerated approval based on tumor response rate and duration of response; continued approval is contingent upon verification and description of clinical benefit in confirmatory trials.
The approval of Imfinzi was based on one single-arm trial which included 182 patients with locally advanced or metastatic urothelial cancer whose disease progressed after prior platinum-containing chemotherapy. All patients received Imfinzi 10mg/kg via intravenous infusion every 2 weeks for up to 12 months or until unacceptable toxicity or disease progression. Tumor assessments were performed at Weeks 6, 12 and 16, then every 8 weeks for the first year and every 12 weeks thereafter. The major efficacy outcome measures were confirmed Objective Response Rate (ORR) according to RECIST v1.1 as assessed by Blinded Independent Central Review (BICR), and duration of response (DoR). Tumor specimens were evaluated prospectively for PD-L1 expression on tumor cells and immune cells at a central laboratory using the FDA-approved Ventana PD-L1 (SP263) Assay (Ventana Medical Systems, Inc.). 
Among the 182 patients, the confirmed ORR was 17% (95% CI: 11.9, 23.3). At the data cutoff for the ORR analysis, median response DoR was not reached (range: 0.9+ to 19.9+ months). The confirmed ORR was 26.3% (95% CI: 17.8, 36.4) in patients with a high PD-L1 score (n=95) and 4.1% (95% CI: 0.9, 11.5) in patients with a low or negative PD-L1 score (n=73); samples for 14 patients were not evaluable. The most common adverse effects reported included fatigue, musculoskeletal pain, constipation, decreased appetite, nausea, peripheral edema, and urinary tract infection.
Durvalumab is a human immunoglobulin G1 kappa (IgG1κ) monoclonal antibody that blocks the interaction of PD-L1 with PD-1 and CD80 (B7.1). Blockade of PD-L1/PD-1 and PD-L1/CD80 interactions releases the inhibition of immune responses, without inducing antibody dependent cell-mediated cytotoxicity (ADCC). PD-L1 blockade with durvalumab led to increased T-cell activation in vitro and decreased tumor size in co-engrafted human tumor and immune cell xenograft mouse models.
Imfinzi will be available in single-dose vials in 500mg/10mL or 120mg/2.4mL strengths.