Roche gets Chinese approval for Tecentriq plus chemotherapy to treat ES-SCLC

罗氏(Roche)公司获得中国批准 Tecentriq 联合化疗治疗 ES-SCLC

2020-02-14 18:00:21 PHARMACEUTICAL


Tecentriq is a monoclonal antibody designed to bind with PD-L1 protein that is expressed on tumour cells and tumour-infiltrating immune cells, restricting its interactions with both PD-1 and B7.1 receptors. Tecentriq may facilitate the activation of T-cells by inhibiting PD-L1. The Chinese approval was based on data from the 403-patient Phase III IMpower133 study, which demonstrated that Tecentriq plus chemotherapy helped people significantly longer compared against chemotherapy alone. The combined therapy also significantly minimised the risk of disease worsening or death compared against chemotherapy alone. Roche’s IMpower133 is a phase III, multicentre, double-blinded and randomised placebo-controlled trial designed to assess the efficacy and safety of Tecentriq plus chemotherapy against chemotherapy alone in chemotherapy-naïve adults with ES-SCLC. Last month, China NMPA also accepted the supplemental Biologics License Application (sBLA) for Tecentriq plus Avastin (bevacizumab) to treat people with unresectable hepatocellular carcinoma (HCC). The sBLA was submitted based on data from the Phase III IMbrave150 study that achieved both of its co-primary endpoints, including OS and PFS. Roche global product development head and chief medical officer Dr Levi Garraway said: “Small cell lung cancer is an area of major unmet need in China and one that has seen limited advances until now. “This approval makes Tecentriq the first cancer immunotherapy available in China for the initial treatment of extensive-stage small cell lung cancer less than a year after the US FDA and EMA approvals, marking a swift and important step forward for patients with this aggressive and difficult-to-treat disease.” In January this year, Roche announced that Tecentriq failed to meet its primary endpoint in phase III muscle-invasive urothelial cancer (MIUC) trail. Tecentriq is being assessed in an extensive development programme, including multiple ongoing and planned Phase III studies, across lung, genitourinary, skin, breast, gastrointestinal, gynaecological, and head and neck cancers. The programme includes trials assessing Tecentriq in both alone, as well as in combination with other medicines.
Tecentriq 是一种单克隆抗体,旨在与 PD-L1蛋白结合,表达于肿瘤细胞和肿瘤浸润的免疫细胞,限制其与 PD-1和 B7.1受体的相互作用。Tecentriq 可以通过抑制 PD-L1来促进 T 细胞的活化。 中国的批准是基于403名患者的第三期 IMpower133研究的数据,该研究表明,与单纯化疗相比, Tecentriq 加化疗能帮助患者长得多。 与单纯化疗相比,联合治疗还能显著降低疾病恶化或死亡的风险。 罗氏(Roche)公司的 IMpower133是一项 III 期、多中心、双盲和随机安慰剂对照试验,旨在评估 Tecentriq 联合化疗单独治疗 ES-SCLC 化疗的疗效和安全性。 上个月,中国 NMPA 还接受了 Tecentriq 和 Avastin (贝伐单抗)的补充生物技术许可申请( sBLA ),用于治疗不可切除肝癌( HCC )。 sBLA 是根据第三阶段 IMbrave150研究的数据提交的,该研究实现了它的共同主要终点,包括 OS 和 PFS 。 罗氏(Roche)全球产品开发主管兼首席医疗官 Levi Garraway 博士表示:“小细胞肺癌是中国一个尚未得到满足的主要领域,迄今进展有限。 “这一批准使 Tecentriq 成为中国首个在美国 FDA 和 EMA 批准后不到一年时间内首次用于大规模小细胞肺癌的癌症免疫疗法,标志着这一侵略性和难治性疾病患者向前迈出了迅速而重要的一步。” 今年1月,罗氏(Roche)公司宣布 Tecentriq 未能达到 III 期肌肉侵袭性尿路上皮癌( MIUC )的主要终点。 Tecentriq 正在广泛的发展方案中进行评估,包括多项正在进行和计划进行的 III 期研究,涉及肺癌、泌尿生殖道、皮肤、乳房、胃肠道、妇科和头颈癌。 该方案包括单独评估 Tecentriq 以及与其他药物联合使用的试验。