树突状细胞疗法ilixadencel获得FDA授予的再生医学高级疗法称号,用于治疗转移性肾细胞癌

2020-05-06 MedSci原创 MedSci原创

Immunicum的同种异体树突状细胞疗法ilixadencel,获得FDA授予的再生医学先进疗法(RMAT)称号,用于治疗转移性肾细胞癌(mRCC)。

Immunicum AB公司宣布其同种异体树突状细胞疗法ilixadencel,已经获得美国食品药品管理局(FDA)授予的再生医学先进疗法(RMAT)称号,用于治疗转移性肾细胞癌(mRCC)。

FDA的决定是基于II期MERECA临床试验结果。MERECA是一项国际、随机、对照和开放标签的II期临床试验,共纳入88名新诊断中度和不良预后的转移性肾癌患者。根据2比1的随机分组,患者在肾脏切除术前接受两次肿瘤内注射的ilixadencel,并在肾脏切除术后接受舒尼替尼或单用舒尼替尼治疗。

MERECA试验显示ilixadencel一直保持积极的安全性和耐受性,并显示出疗效的初步迹象。最新结果显示ilixadencel治疗组的确诊ORR为42.2%(19/45),而舒尼替尼对照组为24.0%(6/25)。

Ilixadencel是一种用于治疗实体瘤的细胞免疫疗法,活性成分是源自健康人的活化同种异体树突状细胞。将这些细胞注射到患者的肿瘤中会引起免疫反应,进而导致患者细胞毒性T细胞的肿瘤特异性活化。

迄今为止,ixiladencel已在各种实体瘤适应症的一系列临床试验中进行了测试,包括转移性肾细胞癌(mRCC)、肝细胞癌(HCC)和胃肠道间质瘤(GIST)以及与几种癌症护理标准相结合,包括酪氨酸激酶抑制剂Sutent(舒尼替尼)和Stivarga(regorafenib)以及检查点抑制剂Keytruda(pembrolizumab)等疗法。

原始出处:

https://www.firstwordpharma.com/node/1721697?tsid=4

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    2020-12-08 维他命
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