LONDON and BOSTON, May 6, 2024 /PRNewswire/ -- Calyx, a leading technology-enabled provider of Medical Imaging services and IRT/RTSM (Interactive Response Technology/Randomized Trial Supply Management) today announced its role in supporting the imaging-based endpoint for the pivotal trial that supported the FDA's groundbreaking approval of Iovance Biotherapeutic's AMTAGVI™ (lifileucel).

伦敦和波士顿，2024年5月6日/PRNewswire/--领先的医学成像服务和IRT/RTSM（交互式响应技术/随机试验供应管理）技术提供商Calyx今天宣布其在支持基于成像的关键试验终点方面的作用，该试验支持FDA对Iovance Biotherapeutic的AMTAGVI™（lifileucel）的开创性批准。

Indicated for the treatment of adult patients with unresectable or metastatic melanoma who have relapsed on other front-line therapy, AMTAGVI is the first cell therapy approved to treat solid tumors, which account for 90% of all cancers..

AMTAGVI用于治疗其他一线治疗复发的不可切除或转移性黑色素瘤成年患者，是第一种被批准用于治疗实体瘤的细胞疗法，占所有癌症的90%。。

Calyx supported Iovance in the trial that led to the approval of AMTAGVI™, the first cell therapy to treat solid tumors

Calyx在试验中支持Iovance，导致AMTAGVI™获得批准，AMTAGVI™是第一种治疗实体瘤的细胞疗法

Calyx Medical Imaging contributed to the design and implementation of the imaging components of the accelerated Phase II clinical trial, enabling 60 investigative sites to capture patient images via CT, MRI, PET, and skin photography in compliance with the protocol. Because image review in cell therapy requires thoughtful and strategic scientific implementation, Calyx's oncology imaging experts designed an image review methodology that enabled uniform and consistent evaluation by Calyx's independent readers..

Calyx Medical Imaging为加速II期临床试验的成像组件的设计和实施做出了贡献，使60个研究站点能够根据协议通过CT，MRI，PET和皮肤摄影捕获患者图像。由于细胞治疗中的图像审查需要深思熟虑和战略性的科学实施，Calyx的肿瘤成像专家设计了一种图像审查方法，使Calyx的独立读者能够进行统一一致的评估。。

'The work that Iovance is doing is extremely important, not only to melanoma patients and their loved ones but also to the broader oncology research community,' said David Herron, CEO of Calyx Medical Imaging. 'We are honored to have played a role in this important development program and look forward to continuing our collaboration with the Iovance team.'.

Calyx Medical Imaging首席执行官大卫·赫伦（DavidHerron）说：“Iovance正在做的工作非常重要，不仅对黑色素瘤患者及其亲人，而且对更广泛的肿瘤学研究界也是如此。”我们很荣幸在这个重要的开发项目中发挥了作用，并期待着继续与Iovance团队合作。”。

For more information on Calyx's experience in oncology trial imaging, visit Oncology Imaging Services| Calyx.

有关Calyx在肿瘤学试验成像方面的经验的更多信息，请访问肿瘤学成像服务| Calyx。

About Calyx

关于花萼

Calyx is a leading global technology-enabled service provider for Medical Imaging and IRT/RTSM (Interactive Response Technology/Randomized Trial Supply Management) for drug developers and the global clinical research community. Calyx's market-leading service, scientific knowledge, expertise, and technology offering help speed up the delivery of life-saving treatments to millions of patients around the world by accelerating and improving clinical trial outcomes..

Calyx是全球领先的技术支持服务提供商，为药物开发人员和全球临床研究界提供医学成像和IRT/RTSM（交互式响应技术/随机试验供应管理）。Calyx市场领先的服务、科学知识、专业知识和技术，通过加速和改善临床试验结果，有助于加速向全球数百万患者提供挽救生命的治疗。。

With operations in six countries, the company provides 24/7 services to most of the world's leading pharma and biotech companies.

该公司在六个国家开展业务，为大多数世界领先的制药和生物技术公司提供全天候服务。

For more information go to Calyx.ai and follow us on LinkedIn, Twitter, and Facebook.

有关更多信息，请访问Calyx.ai，并在LinkedIn、Twitter和Facebook上关注我们。

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SOURCE Calyx

源花萼