Immutep Announces Successful Meeting With FDA On Phase III Design In Non-Small Cell Lung Cancer; TACTI-004 Registrational Trial Will Enrol ~750 Patients Regardless Of PD-L1 Expression In Order To Address The Entire 1l NSCLC Market Eligible For...
Immutep Announces Successful Meeting With FDA On Phase III Design In Non-Small Cell Lung Cancer; TACTI-004 Registrational Trial Will Enrol ~750 Patients Regardless Of PD-L1 Expression In Order To Address The Entire 1l NSCLC Market Eligible For...
Immutep Announces Successful Meeting With FDA On Phase III Design In Non-Small Cell Lung Cancer; TACTI-004 Registrational Trial Will Enrol ~750 Patients Regardless Of PD-L1 Expression In Order To Address The Entire 1l NSCLC Market Eligible For Anti-PD-1 Therapy
Immutep宣布在非小细胞肺癌III期设计上与FDA会议成功； TACTI-004注册试验将招募约750名患者，无论PD-L1表达如何，以应对符合抗-PD-1治疗条件的整个一线NSCLC市场
- Final discussion with the FDA, successfully concluding the regulatory preparations for the TACTI-004 Phase III trial design to evaluate efti in combination with KEYTRUDA (pembrolizumab), MSD's anti-PD-1 therapy, and standard chemotherapy in first-line non-small cell lung cancer
- TACTI-004 registrational trial will enrol ~750 patients regardless of PD-L1 expression in order to address the entire 1L NSCLC market eligible for anti-PD-1 therapy
- 最终与FDA讨论，顺利完成TACTI-004 Phase III试验设计的监管准备工作，该试验将评估efti与KEYTRUDA（pembrolizumab） ，MSD的抗PD-1治疗和1线非小细胞肺癌的标准化疗的联合应用。
- TACTI-004注册试验将招募约750名患者，无论PD-L1表达如何，以应对符合抗-PD-1治疗条件的整个1L NSCLC市场
SYDNEY, AUSTRALIA, July 22, 2024 (GLOBE NEWSWIRE) -- Immutep Limited ((ASX: IMM, NASDAQ:IMMP) ("Immutep" or "the Company"), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, today announces that positive feedback has been received from the US Food and Drug Administration ("FDA") regarding the planned TACTI-004 Phase III trial of eftilagimod alfa ("efti") in combination with KEYTRUDA (pembrolizumab), MSD's anti-PD-1 therapy, and histology-based platinum doublet chemotherapy for the treatment of first-line metastatic non-small cell lung cancer (1L NSCLC), regardless of PD-L1 expression.
2024年7月22日，澳洲悉尼（GLOBE NEWSWIRE） - 临床阶段生物技术公司Immutep Limited（（ASX: IMm、NASDAQ:IMMP）（“Immutep”或“公司”）宣布美国食品和药物管理局（“FDA”）已经对eftilagimod alfa（“efti”）与KEYTRUDA（pembrolizumab）的TACTI-004第III期试验提供回应，MSD的抗PD-1治疗，以及基于组织学的铂双t化疗，用于一线转移性非小细胞肺癌（1L NSCLC），无论PD-L1表达如何，收到了积极反馈。
The FDA feedback from this Type C meeting, along with feedback previously received from the Paul-Ehrlich-Institut ("PEI") and the Spanish Agency for Medicines and Health Products ("AEMPS"), concludes the preparatory regulatory interactions for the design of this registrational trial. This marks a significant step forward to develop an effective treatment for non-squamous and squamous 1L NSCLC patients who have high, low, or no PD-L1 expression and are eligible for anti-PD-1 therapy.
这次C型会议的FDA反馈，以及之前收到的Paul-Ehrlich-Institut （“PEI”）和西班牙药品和医疗产品管理局（“AEMPS”）的反馈，结论了这项注册试验的设计准备监管互动。这标志着为高、低或不具有PD-L1表达并符合抗PD-1治疗条件的非鳞状和鳞状1L NSCLC患者开发有效治疗方案向前迈出了重要一步。
The TACTI-004 Phase III trial, which will enrol ~750 patients, is based on the positive efficacy and safety data in 1L NSCLC generated from the TACTI-002 Phase II and INSIGHT-003 trials.
TACTI-004第III期试验将招募约750名患者，基于TACTI-002第II期和INSIGHt-003试验中收集的1L NSCLC的积极疗效和安全性数据。