「抗癌管家」全球肿瘤免疫治疗信息精选【第一期】—抗癌管家( 五 )

Basel, today announced the completion of a supplemental Biologics License Application (sBLA) submission to the US Food and Drug Administration (FDA) for Tecentriq? (atezolizumab) in combination with Avastin? (bevacizumab), for the treatment of people with unresectable hepatocellular carcinoma (HCC) who have not received prior systemic therapy. The FDA is reviewing the application under the Real-Time Oncology Review pilot programme, which aims to explore a more efficient review process to ensure safe and effective treatments are available to patients as early as possible. In July 2018, the FDA granted Breakthrough Therapy Designation for Tecentriq in combination with Avastin in HCC based on data from an ongoing Phase Ib trial.
此次申请基于IMbrave150研究的III期试验成果，证实了与索拉非尼相比，阿特珠单抗与贝伐单抗联合用药明显提高了患者的总生存率。将疾病进展和死亡风险降低了41% 。从安全性方面，阿特珠单抗与贝伐单抗的安全性与每种药物的已知安全性一致。此试验结果也于2019年11月在欧洲肿瘤内科学会（ESMO）亚洲大会上发布。
This application is based on the results of the Phase III IMbrave150 study, which demonstrated that Tecentriq in combination with Avastin reduced the risk of death (overall survival; OS) by 42% (hazard ratio [HR]=0.58; 95% CI: 0.42-0.79; p=0.0006) and reduced the risk of disease worsening or death (progression-free survival; PFS) by 41% (HR=0.59; 95% CI: 0.47–0.76; p<0.0001), compared with sorafenib. Safety for Tecentriq and Avastin was consistent with the known safety profiles of the individual medicines. The results were presented at the European Society for Medical Oncology (ESMO) Asia Congress in November 2019.
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来源：Business Wire
发生区域：美国
发布时间：2020.01.27
摘要：Hyleukin-7（NT-I7）联合帕博利珠单抗
（Pembrolizumab）治疗复发/难治性晚期实体瘤：美国FDA已批准IND申请
关键字：NT-I7、帕博利珠单抗、K药、联合治疗、FDA
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原文：
美国NeoImmuneTech是一家专注于T细胞研究的生物制药公司。日前公司正式宣布美国食品药品监督管理局已批准Hyleukin-7（NT- I7）与默克公司的抗PD-1抗体（帕博利珠单抗）用于联合治疗复发/难治性（R/R）晚期实体瘤患者的新药临床试验申请。此申请也意味着允许NeoImmuneTech启动Ib/IIa期临床试验。
NeoImmuneTech, Inc., a clinical-stage T cell-focused biopharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application for the combination of NeoImmuneTech’s Hyleukin-7 (NT-I7) and Merck’s anti-PD-1 therapy KEYTRUDA (pembrolizumab) for the treatment of patients with relapsed/refractory (R/R) advanced solid tumors. This IND clearance allows NeoImmuneTech to initiate a Phase 1b/2a basket study evaluating this combination in patients with both checkpoint inhibitor (CPI)-treated and CPI-na?ve R/R advanced solid tumors.
这项研究的目的是探索合理的给药方案，并探讨该联合用药在患有治疗复发/难治性（R/R）晚期实体瘤患者中的初步抗肿瘤活性。这项研究的结果将用于进一步探索其他癌种的研究。